(267 days)
No
The document describes standard automated urine analysis using reflectance photometry and image scanning technology, without mentioning any AI or ML algorithms for data processing or interpretation.
No
Explanation: The device is an automatic urine analyzer intended for in vitro diagnostic use to detect various analytes in urine, providing information for screening and auxiliary diagnosis, not for treating any condition.
Yes
The device is an "Automatic Urine Analyzer" intended for "in vitro diagnostic use only." It performs semi-quantitative/qualitative detection of various analytes in urine to provide information regarding health status, and it is explicitly stated that "Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria."
No
The device description clearly states it is an "automated instrument" that performs physical operations like "sample transmitting, sample aspirating, sample dropping, rinsing strip feeding and color identifying". It also mentions a built-in printer. These are hardware components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The UC-1800 Automatic Urine Analyzer is automated instrument which is intended for professional, in vitro diagnostic use only."
- Purpose: The device is designed to perform tests on urine samples (which are biological specimens taken from the body) to provide information about a patient's health status (carbohydrate metabolism, kidney and liver function, acid-base balance, bacteriuria). This is the core function of an in vitro diagnostic device.
- Use with Reagents: It is used in conjunction with specific urine reagent strips (URIT 11FA and URIT 12FA), which are also explicitly stated to be for "professional, in vitro diagnostic use only."
- Clinical Setting: The intended user is a "Professional" and the device is used in a "Clinical Laboratory," which are typical settings for IVD use.
The entire description and intended use clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UC-1800 Automatic Urine Analyzer is automated instrument which is intended for professional, in vitro diagnostic use only.
Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, setone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
Product codes
JIO, JIL, JFY, CDM, CEN, JIN, JJB, JMT, LJX, JRE, JMA, JIR, KQO
Device Description
UC-1800 Automatic Urine Analyzer is characterized by fully automated and simple operation. All you need to do is to set test strips and samples, press the START key, and the rest of operations are fully automated with UC-1800, which can measure samples continuously. For each measurement, the instrument automatically performs a series of operation: sample transmitting, sample aspirating, sample dropping, rinsing strip feeding and color identifying, etc. The instrument is used in conjunction with a serial of URIT urine test strips for measuring 15 parameters. Measure results are printed through either built-in printer or external printer. The device is described as below.
Test strip measurement principle
Measurement of test strips is done by the reflectance photometry method.
Placing tube racks loaded with samples on the rack injection mechanism and clicking the START key, the instrument will automatically perform a series of operations, such as transmitting samples, selecting strips, reading barcode, aspirating samples, dropping samples, measuring samples and printing results, until all tube racks are done. During the measurement, the reacted pads on strip (calibration pad is not involved in reaction, just for reference) will change colors and absorb irradiated monochromatic light as a result of chemical reaction within 60 seconds. Then the optical mechanism will compare the reflective light amount of each reacted pad with the reflective light amount of the concentrations of analyzes will be calculated by CPU and printed together with semi-quantitative symbols.
The measuring system consists of a light source (LED) and a light rom the light source falls on the reacted pads and the calibration pad on the strip. The absorbent and reflective light amounts vary with the color of reagent pads. If the color is darker, more light is absorbed, and less light is reflected, vice versa. i.e., the degree of color development is proportional to the concentration of analyzes in urine. The reflectance is calculated using the following formula:
R% = (Tm * Cs) / (Ts * Cm) * 100%
R: Reflectance
Tm: Reflective light amount at the reactive pad with the measurement wavelength
Ts: Reflective light amount at the reactive pad with the reference wavelength
Cm: Reflective light amount at the calibration pad with the measurement wavelength
Cs: Reflective light amount at the calibration pad with the reference wavelength
The reflected lights from reagent pads are transmitted in the optical unit and received by the light receptor, where the optical signals are transformed into electrical signals. Then the electrical signals are transformed through I/V converter, processed by CPU and finally printed out.
Specific gravity measurement principle
Specific gravity measurement method is refractometer, which using the correlation between light refractive index and total solids in the solution to determine.
Refractometer method, available at 15℃~38℃ temperature range of use can be calibrated by the temperature compensation device; available for use the known standard high specific gravity concentration solution and standard low specific gravity deionized water to calibrate; easy to standardization, less quantity of samples, especially suitable for patients with oliguria and pediatric patients. Refractometer method is reference method by Clinical Laboratory Standard Institution, CLSI and Chinese Committee for Clinical Laboratory Standards, CCCLS.
Specific gravity is based on the principle of different concentrations of urine sample which have different refractive indexes to measure, that is uses the same wavelength of monochromatic parallel light comes into the contains urine sample, and then according to position of refracted ray in photoelectric technology detector (displacement sensor) to determine the specific gravity value.
Specific gravity results are calculated by the following formulas:
SGX = { SGH - SGL } * (KX - KL) / (KH - KL) + SGL
can change to
(SGX - SGL) / (SGH - SGL) = (KX - KL) / (KH - KL)
relationship between them is linear.
SGH: The specific gravity of high concentration solution
SGL: The specific gravity of low concentration solution
SGX: The specific gravity of sample solution
KH: High concentration solution position coefficient
KL: Low concentration solution position coefficient
KX: Sample solution position coefficient
Position coefficient: It is calculated by the detector output data, and has a linear relationship with the refractive index.
Refractive index change depends on the temperature of the sample solution, and the specific gravity value is using the following formula to correct.
SGt = SGX + {TSAM - TSTD} * Ct
SGt: The specific gravity of high concentration solution
SGx: The specific gravity of low concentration solution
TSAM: The temperature of sample solution
TSTD: The temperature of low concentration solution
Ct: Temperature coefficient (SG 0.001/3°C) (temperature coefficient)
If the urine sample contains large amounts of glucose or protein, then the specific gravity will be affected, according to WS/T 229-229 "Physical, chemical and microscopic examination of urine" 5.4.1 requirements: 1 g/L protein will increase urine specific gravity 0.0003, 1 g/L glucose will increase urine specific gravity 0.0004. So, the specific gravity results will be corrected through the glucose and protein level which was measured by the test strip.
SG = SGt - CGLU - CPRO
SG: Specific gravity value which after the temperature compensation
SGt: Specific gravity value which gets from formula (4)
CGLU: Glucose correction value
CPRO: Protein correction value
Turbidity measurement principle
Turbidity module emits light, to make it go through the sample, and then detect how much light is scattered by the particles in the water from the direction at a 90-degree angle to the incident light (The most stable angle of scattered light, is at a right angle to the center line of the incident light, so measuring the scattered light from 90° direction which can minimize the influence of particle size on scattering light intensity). This scattered light measurement method called scattering method.
Turbidity result is calculated by the following formula:
T = (Ss/Ts - Sw/Tw)/K
T: Turbidity level
Ss: Sample scattered light level
Ts: Sample transmission light level
Sw: Flushing fluid scattered light level
Tw: Flushing fluid transmission light level
K: Coefficient factor
Color measurement principle
The color of often seen objects, are actually the objects surfaces absorb a part of chromatic light from the white light(sunlight) that fall on them, and then reflect the other part of chromatic light to human eyes' response. Various frequencies of visible light are mixed together become white, that is to say, it contains all sorts of color of light, such as red(R), yellow(Y), green(G), blue(B), purple(P). According to the German physicist Helinholtz's three primary colors theory, all sorts of color is made of different proportion of three primary colors (red, green, blue).
Primary colors are the "basic color" which cannot be gotten by other colors mixed. But mix the primary colors in different proportion will get other new colors. Three primary colors of light are RGB (Red, Green, and Blue). Equivalent red light +green light=yellow light, green light +blue light = cyan light. Equivalent red light = magenta light, equivalent red +green+ blue=white, and if the intensity of these three lights is zero, it is black (dark).
When the white light through colored solution colors light will be absorbed, so the color of the light through the solution can be expressed as the color of the solution color can be detected by the professional color recognition sensor (filter) which in the back-end of the solution.
URIT 11FA/12FA urine reagent strips
Urine Reagent Strips is used to determine the components to be measured in urine by dry chemistry method together with urine analyzer. Various components to be tested in the urine can result in changes to the colors of corresponding reagent blocks on the Urine Reagent Strips. The depth of reaction color is proportional to the corresponding component to be tested in the urine. Qualitative and semi-quantitative detection can be conducted to the contents of the corresponding detected components. As a reagent for the determination of multiple components in human urine and the most basic test item for clinical urine routine test), it is suitable for the screening test or auxiliary diagnosis for clinical diagnosis, without the specificity for diseases or indications, and urine dry chemistry test is a screening test and cannot be used as a single diagnostic method.
Ascorbic Acid
Based on the principle of Tillman's Reagent, Ascorbic acid can reduce the dye from blue to red. The purpose of the determination of this project is to provide the user with the content of Ascorbic acid in the sample to determine its possible interference.
Nitrite
In this reaction, nitrate is reduced to nitrite by Gram-negative bacteria in the nitrite will react with arsanilic acid to form a diazonium compound and the diazonium compound with naphthy ethylenediamine dihydrochloride to show a pink color.
Microalbumin
Based on the dye-binding method, microalbumin can react with the dye to form a pink complex and generate produce a color change, which is particularly sensitive to the reaction of albumin.
Leukocytes
Based on the principle of esterase method, granulosa cytoplasm contains esterase which can hydrolyze a 3-hydroxyindoxyl ester substrate, release phenol and react with diazo reagent to generate purple-red compounds.
Creatinine
Based on the principle of displacement reaction, creatinine can displace the dye in the metal chloride-acid dye complex, and the color will change from green to yellow.
Ketone
Based on the principle of sodium nitroprussiate method, sodium nitroprusside can interact with ketone (acetoacetate) under alkaline conditions to become purple, especially acetoacetate is particularly sensitive to this.
Urobilinogen
Based on the principle of azo-binding method, urobilinogen is coupled with diazonium salt under strong acid conditions to form carmine pigment.
Bilirubin
Based on the principle of azo-coupline method,2,4-dichloroaniline diazonium salt can react specifically with bilirubin, and produce different colors depending on the concentration of bilirubin.
Glucose
Based on the reaction principle of glucose oxidase can specifically oxidize ß-D-glucose to generate glucuronic acid and hydrogen peroxide that will oxidize the indicator under the action of peroxidase and show a purple-red color.
Protein
Based on the principle of protein error method of dye binding, the protein can combine with the dye to form a complex that produce a color change, especially the response to albumin is more sensitive than that of globulin, hemoglobin, Bence-Jone protein and mucin.
Blood
Based on the principle of hemoglobin contact activity method, the decomposition of peroxides can be catalyzed through the peroxidase-like action of hemoglobin, so that tetramethylbenzidine is oxidized and colored.
Specific Gravity
Using the polyelectrolyte method, and based on the principle of ion exchange between electrolytes in urine and polyelectrolytes. In the presence of cations, the polymer hydrogen ions will be released through exchange, and the color of bromothymol blue indicator will change from blue to blue-green and finally to yellow.
pH
The pH value within the range from 5.0 to 9.0 is measured by pH indicator, and the pH value of fresh urine of normal people is within the range from 5.5 to 7.0.
Mentions image processing
Yes, "Measurement of test strips is done by the reflectance photometry method, using CIS (contact image sensor) image scanning analysis technology to detect."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Reflectance photometry, Refractometer, Light-transmission measurement, Light-scattering measurement.
Anatomical Site
Urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional, in vitro diagnostic use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance
Precision /Reproducibility
Repeatability (With-in Run) Precision:
- Sample size: Each sample was tested in 20 replicates across 3 instruments with 3 lots of URIT 11FA Urine Reagent Strips and 3 lots of URIT 12FA Urine Reagent Strips in each instrument, for a total of 60 measurements at each concentration.
- Key results: All tests had 60 of 60 (100%) match at +/- one color block for both URIT 11FA and URIT 12FA Urine Reagent Strips, and for physical module items (Turbidity, Color). All concluded as Qualified.
Reproducibility (Between-Run) Precision:
- Sample size: Each sample was tested for 20 days with 2 runs per day, in 1 time per run in 3 sites, each site with 1 instrument. The test was performed across 3 instruments with 3 lots of URIT 11FA Urine Reagent Strips and 3 lots of URIT 12FA Urine Reagent Strips in each instrument by 3 operators, each operator performing the test for 6-7 days, for a total of 120 measurements at each concentration.
- Key results: All concentrations for all tests had 120 of 120 (100%) match at +/- one color block for both URIT 11FA and URIT 12FA Urine Reagent Strips, and for physical module items (Turbidity, Color). All concluded as Qualified.
Linearity/assay reportable range
- URIT 11/12 FA Urine Reagent Strips (Common Item): All analytes showed 100% agreement at the same block and within +/- one block across all tested concentrations. Test conducted on three UC-1800 machines and repeated 21 times for each batch of test strips.
- URIT 11FA Urine Reagent Strips (Ascorbic acid): All concentrations showed 100% agreement at the same block and within +/- one block.
- URIT 12FA Urine Reagent Strips (Microalbumin & Creatinine): All concentrations showed 100% agreement at the same block and within +/- one block.
Analytical Sensitivity
- Summary of minimum detection limits for various analytes for URIT 11FA and 12FA Urine Reagent Strips. Analytical sensitivity is not applicable for pH and Specific Gravity.
- Critical value (URIT 11FA/12FA Urine Reagent Strips): Agreement rates for various analytes at different concentrations (e.g., Glucose 100 (1+) = 86% (11FA), 73% (12FA); Leukocyte 70(1+) = 92% (11FA), 74% (12FA)).
Analytical specificity
Exogenous and Endogenous Interference:
- Substances showing no interference for all analytes were identified (e.g., Cefoxitin, Ofloxacin, Tetracycline, Protein, Lactose, etc.) at their maximum tested concentrations.
- Substances causing interference were identified, along with their maximum non-interfering concentration, interference concentration, specific effect (e.g., false positive/negative, elevated positive result), and applicable strip type.
Effect of urine pH:
- Leukocytes: pH values lower than 5.5 may yield a false negative result. No significant interference observed for pH > 5.5.
- Specific Gravity: pH values lower than 5.5 may yield a false increased result (False Positive). pH values higher than 7.5 may yield a decreased result (False Negative). No significant interference observed for pH 5.5-7.5.
Effect of urine color: All tested colors (red, orange, brown, yellow, green, blue, purple) showed no interference on each analyte for both URIT 11/12FA Urine Reagent Strips across all tested concentrations.
Effect of urine Specific Gravity:
- Leukocytes: SG >= 1.040 may yield a false negative result. No interference for SG
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 26, 2024
URIT Medical Electronic Co., Ltd. c/o Dylan Wu, Consultant Shanghai SUNGO Management Consutling Co., Ltd. Room 1401, Dongfang Building, 1500# Century AVE Shanghai 200122, China
Re: K232317
Trade/Device Name: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: JIO, JIL, JFY, CDM, CEN, JIN, JJB, JMT, LJX, JRE, JMA, JIR, KQO Dated: March 29, 2024 Received: March 29, 2024
Dear Dylan Wu:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232317
Device Name
UC-1800 Automatic Urine Analyzer URIT 11FA Urine Reagent Strips URIT 12FA Urine Reagent Strips
Indications for Use (Describe)
The UC-1800 Automatic Urine Analyzer is automated instrument which is intended for professional, in vitro diagnostic use only.
Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, setone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary
K232317
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement by 21 CFR 807.92
Date prepared: 25th, April 2024
1 Submitter's Information
Name: URIT Medical Electronic Co., Ltd. Address: No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China Contact Person: Jun Jiang Title: Manager Tel: 0773-2288586 FAX: 0773-2288560 Email: service@uritest.com 2 Official Contact Person Information
Primary contact: Mr. Dylan Wu Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-18616797137 Email: haiyang.wu@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
3 Subject Device
3.1 Trade Name and Regulatory Information:
| No. | Trade name | Regulatory Information |
|---|---|---|
| 1 | UC-1800 | |
| Automatic Urine | ||
| Analyzer | Class I §21 CFR 862.2900 | |
| Automated Urinalysis System | ||
| 3 | URIT 11FA Urine | |
| Reagent Strips | Class II (Blood and Glucose analytes | |
| raise system to Class II / 510(k) | ||
| required) | ||
| 4 | URIT 12FA Urine | |
| Reagent Strips | Class II (Blood, Glucose and Creatinine | |
| analytes raise system to Class II / | ||
| 510(k) required) |
3.2 Classification Information
| No. | Regulation
21 CFR Section | Product
Code | Classification | Description | Panel |
|-----|------------------------------|-----------------|----------------|---------------------------------------------|--------------------|
| 1 | 862.2900 | KQO | Class I | Automated Urinalysis System | Clinical Chemistry |
| 2 | 862.1225 | JFY | Class II | Creatinine test System | Clinical Chemistry |
| 3 | 862.1645 | JIR | Class I | Protein or Albumin
(Urinary, Non-Quant.) | Clinical Chemistry |
4
| No. | Regulation
21 CFR Section | Product
Code | Classification | Description | Panel |
|-----|------------------------------|-----------------|----------------|-------------------------------------------------------------|--------------------|
| 4 | 862.1340 | JIL | Class II | Glucose
(Urinary, Non-Quantitative) | Clinical Chemistry |
| 5 | 864.6550 | JIO | Class II | Blood, Occult, Colorimetric, In Urine | Hematology |
| 6 | 862.1785 | CDM | Class I | Urobilinogen
(Urinary Non-Quant.) | Clinical Chemistry |
| 7 | 862.1550 | CEN | Class I | pH
(Urinary, Non-Quant.) | Clinical Chemistry |
| 8 | 862.1435 | JIN | Class I | Ketones
(Urinary, Non-Quant.) | Clinical Chemistry |
| 9 | 862.1645 | JIR | Class I | Protein or Albumin
(Urinary, Non-Quant.) | Clinical Chemistry |
| 10 | 862.1115 | JJB | Class I | Urinary Bilirubin & Its Conjugates
(Urinary, Non-Quant.) | Clinical Chemistry |
| 11 | 862.1510 | JMT | Class I | Nitrite (Urinary, Non-Quant.) | Clinical Chemistry |
| 12 | 864.7675 | LJX | Class I | Leukocyte peroxidase test | Hematology |
| 13 | 862.2800 | JRE | Class I | Specific Gravity | Clinical Chemistry |
| 14 | 862.1095 | JMA | Class I | Ascorbic Acid Test System | Clinical Chemistry |
4 Predicate device
510(k) Number: K082811 Uritest 500B Urine Analyzer Uritest 50 Urine Analyzer Uritest 10G Urine Reagent Strips Uritest 11G Urine Reagent Strips
510(k) Number: K142391 Mission® U120 Ultra Urine Analyzer Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls
510(k) Number: K093098 AUTION MAX AX-4030 Urinalysis System
5 Device Description
5.1 UC-1800 Automatic Urine Analyzer
UC-1800 Automatic Urine Analyzer is characterized by fully automated and simple operation. All you need to do is to set test strips and samples, press the START key, and the rest of operations are fully automated with UC-1800, which can measure samples continuously. For each measurement, the instrument automatically performs a series of operation: sample transmitting, sample aspirating, sample dropping, rinsing strip feeding and color identifying, etc. The instrument is used in conjunction with a serial of URIT urine test strips for measuring 15 parameters. Measure results are printed through either built-in printer or external printer. The device is described as below.
Test strip measurement principle a
Measurement of test strips is done by the reflectance photometry method.
Placing tube racks loaded with samples on the rack injection mechanism and clicking the START key, the instrument will automatically perform a series of operations, such as transmitting samples, selecting strips, reading barcode, aspirating
5
samples, dropping samples, measuring samples and printing results, until all tube racks are done. During the measurement, the reacted pads on strip (calibration pad is not involved in reaction, just for reference) will change colors and absorb irradiated monochromatic light as a result of chemical reaction within 60 seconds. Then the optical mechanism will compare the reflective light amount of each reacted pad with the reflective light amount of the concentrations of analyzes will be calculated by CPU and printed together with semi-quantitative symbols.
The measuring system consists of a light source (LED) and a light rom the light source falls on the reacted pads and the calibration pad on the strip. The absorbent and reflective light amounts vary with the color of reagent pads. If the color is darker, more light is absorbed, and less light is reflected, vice versa. i.e., the degree of color development is proportional to the concentration of analyzes in urine. The reflectance is calculated using the following formula:
$$\text{R%} = \frac{T_m \cdot \mathcal{C}_s}{T_s \cdot \mathcal{C}_m} \times 100% \tag{1}$$
R: Reflectance
Tm: Reflective light amount at the reactive pad with the measurement wavelength
Ts: Reflective light amount at the reactive pad with the reference wavelength
Cm: Reflective light amount at the calibration pad with the measurement wavelength
Cs: Reflective light amount at the calibration pad with the reference wavelength
The reflected lights from reagent pads are transmitted in the optical unit and received by the light receptor, where the optical signals are transformed into electrical signals. Then the electrical signals are transformed through I/V converter, processed by CPU and finally printed out.
b Specific gravity measurement principle
Specific gravity measurement method is refractometer, which using the correlation between light refractive index and total solids in the solution to determine.
Refractometer method, available at 15℃~38℃ temperature range of use can be calibrated by the temperature compensation device; available for use the known standard high specific gravity concentration solution and standard low specific gravity deionized water to calibrate; easy to standardization, less quantity of samples, especially suitable for patients with oliguria and pediatric patients. Refractometer method is reference method by Clinical Laboratory Standard Institution, CLSI and Chinese Committee for Clinical Laboratory Standards, CCCLS.
Specific gravity is based on the principle of different concentrations of urine sample which have different refractive indexes to measure, that is uses the same wavelength of monochromatic parallel light comes into the contains urine sample, and then according to position of refracted ray in photoelectric technology detector (displacement sensor) to determine the specific gravity value. Specific gravity measurement principle functional block diagram is shown in Figure 1 below.
Image /page/5/Figure/14 description: The image shows a light ray entering a prism and being refracted. The light ray is labeled "Light ray" and the refracted ray is labeled "Refracted ray". The prism is labeled "Prism" and a detector is labeled "Detector".
Figure 1 Specific gravity measurement principle
Specific gravity results are calculated by the following formulas:
$$SG_X = \left{ SG_H - SG_L \right} \cdot \frac{K_X - K_L}{K_H - K_L} + SG_L \tag{2}$$
can change to
$$\frac{SG_X - SG_L}{SG_H - SG_L} = \frac{K_X - K_L}{K_H - K_L} \tag{3}$$
relationship between them is linear.
SGH: The specific gravity of high concentration solution
6
SGL: The specific gravity of low concentration solution
SGX: The specific gravity of sample solution
KH: High concentration solution position coefficient
KL: Low concentration solution position coefficient
KX: Sample solution position coefficient
Position coefficient: It is calculated by the detector output data, and has a linear relationship with the refractive index.
Refractive index change depends on the temperature of the sample solution, and the specific gravity value is using the following formula to correct.
$$\text{SG}_t = \text{SG}_X + {T_{SAM} - T_{STD}} \cdot \mathcal{C}_t \tag{4}$$
SGt: The specific gravity of high concentration solution
SGx: The specific gravity of low concentration solution
TSAM: The temperature of sample solution
TSTD: The temperature of low concentration solution
Ct: Temperature coefficient (SG 0.001/3°C) (temperature coefficient)
If the urine sample contains large amounts of glucose or protein, then the specific gravity will be affected, according to WS/T 229-229 "Physical, chemical and microscopic examination of urine" 5.4.1 requirements: 1 g/L protein will increase urine specific gravity 0.0003, 1 g/L glucose will increase urine specific gravity 0.0004. So, the specific gravity results will be corrected through the glucose and protein level which was measured by the test strip.
$$\mathcal{SG} = \mathcal{SG}_t - \mathcal{C}_{GLU} - \mathcal{C}_{PRO} \tag{5}$$
SG: Specific gravity value which after the temperature compensation
SGt: Specific gravity value which gets from formula (4)
CGLU: Glucose correction value
CPRO: Protein correction value
C Turbidity measurement principle
Turbidity module emits light, to make it go through the sample, and then detect how much light is scattered by the particles in the water from the direction at a 90-degree angle to the incident light (The most stable angle of scattered light, is at a right angle to the center line of the incident light, so measuring the scattered light from 90° direction which can minimize the influence of particle size on scattering light intensity). This scattered light measurement method called scattering method. Turbidity measurement principle functional block diagram is shown in Figure 2 below.
Image /page/6/Figure/22 description: The image shows a diagram of a glass making sample pool. A light ray enters the pool from the left and is scattered in different directions. Transmission light exits the pool to the right and is measured by a detector. Scattered light at 90 degrees is also measured by a detector.
Figure 2 Turbidity measurement principle
Turbidity result is calculated by the following formula:
$$T = \left(\mathbb{S}_{\mathcal{S}}/T_{\mathbb{S}} - \mathbb{S}_{W}/T_{W}\right)/K \tag{6}$$
T: Turbidity level
7
Ss: Sample scattered light level
Ts: Sample transmission light level
Sw: Flushing fluid scattered light level
Tw: Flushing fluid transmission light level
K: Coefficient factor
d Color measurement principle
The color of often seen objects, are actually the objects surfaces absorb a part of chromatic light from the white light(sunlight) that fall on them, and then reflect the other part of chromatic light to human eyes' response. Various frequencies of visible light are mixed together become white, that is to say, it contains all sorts of color of light, such as red(R), yellow(Y), green(G), blue(B), purple(P). According to the German physicist Helinholtz's three primary colors theory, all sorts of color is made of different proportion of three primary colors (red, green, blue).
Primary colors are the "basic color" which cannot be gotten by other colors mixed. But mix the primary colors in different proportion will get other new colors. Three primary colors of light are RGB (Red, Green, and Blue). Equivalent red light +green light=yellow light, green light +blue light = cyan light. Equivalent red light = magenta light, equivalent red +green+ blue=white, and if the intensity of these three lights is zero, it is black (dark).
When the white light through colored solution colors light will be absorbed, so the color of the light through the solution can be expressed as the color of the solution color can be detected by the professional color recognition sensor (filter) which in the back-end of the solution.
Image /page/7/Figure/10 description: The image shows a diagram of a glass making sample pool. A white light ray is shown entering the glass making sample pool, which is represented by a circle. After passing through the sample pool, the light is labeled as transmission light. The transmission light then passes through an RGB light filter before reaching a detector.
RGB light fliter
Figure 3 Principle of color detection
5.2 URIT 11FA/12FA urine reagent strips
Urine Reagent Strips is used to determine the components to be measured in urine by dry chemistry method together with urine analyzer. Various components to be tested in the urine can result in changes to the colors of corresponding reagent blocks on the Urine Reagent Strips. The depth of reaction color is proportional to the corresponding component to be tested in the urine. Qualitative and semi-quantitative detection can be conducted to the contents of the corresponding detected components. As a reagent for the determination of multiple components in human urine and the most basic test item for clinical urine routine test), it is suitable for the screening test or auxiliary diagnosis for clinical diagnosis, without the specificity for diseases or indications, and urine dry chemistry test is a screening test and cannot be used as a single diagnostic method.
a Ascorbic Acid
Based on the principle of Tillman's Reagent, Ascorbic acid can reduce the dye from blue to red. The purpose of the determination of this project is to provide the user with the content of Ascorbic acid in the sample to determine its possible interference.
Nitrite b
In this reaction, nitrate is reduced to nitrite by Gram-negative bacteria in the nitrite will react with arsanilic acid to form a diazonium compound and the diazonium compound with naphthy ethylenediamine dihydrochloride to show a pink color.
8
Microalbumin C
Based on the dye-binding method, microalbumin can react with the dye to form a pink complex and generate produce a color change, which is particularly sensitive to the reaction of albumin.
Leukocytes d
Based on the principle of esterase method, granulosa cytoplasm contains esterase which can hydrolyze a 3-hydroxyindoxyl ester substrate, release phenol and react with diazo reagent to generate purple-red compounds.
Creatinine e
Based on the principle of displacement reaction, creatinine can displace the dye in the metal chloride-acid dye complex, and the color will change from green to yellow.
f Ketone
Based on the principle of sodium nitroprussiate method, sodium nitroprusside can interact with ketone (acetoacetate) under alkaline conditions to become purple, especially acetoacetate is particularly sensitive to this.
Urobilinogen g
Based on the principle of azo-binding method, urobilinogen is coupled with diazonium salt under strong acid conditions to form carmine pigment.
h Bilirubin
Based on the principle of azo-coupline method,2,4-dichloroaniline diazonium salt can react specifically with bilirubin, and produce different colors depending on the concentration of bilirubin.
i Glucose
Based on the reaction principle of glucose oxidase can specifically oxidize ß-D-glucose to generate glucuronic acid and hydrogen peroxide that will oxidize the indicator under the action of peroxidase and show a purple-red color.
Protein j
Based on the principle of protein error method of dye binding, the protein can combine with the dye to form a complex that produce a color change, especially the response to albumin is more sensitive than that of globulin, hemoglobin, Bence-Jone protein and mucin.
k Blood
Based on the principle of hemoglobin contact activity method, the decomposition of peroxides can be catalyzed through the peroxidase-like action of hemoglobin, so that tetramethylbenzidine is oxidized and colored.
l Specific Gravity
Using the polyelectrolyte method, and based on the principle of ion exchange between electrolytes in urine and polyelectrolytes. In the presence of cations, the polymer hydrogen ions will be released through exchange, and the color of bromothymol blue indicator will change from blue to blue-green and finally to yellow.
pH m
The pH value within the range from 5.0 to 9.0 is measured by pH indicator, and the pH value of fresh urine of normal people is within the range from 5.5 to 7.0.
6 Indications for use/Intended use
The UC-1800 Automatic Urine Analyzer is automated instrument, which is intended for professional, in vitro diagnostic use only.
Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, letone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate
9
metabolism, kidney and liver function, acid-base balance and bacteriuria.
The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilingen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
| Table 1 Technological characteristics of Proposed Device | |
|---|---|
| Feature | UC-1800 Automatic Urine Analyzer |
| Methodology | Reflectance photometer |
| Principle | Measurement of test strips is done by the reflectance |
| photometry method, using CIS (contact image sensor) image | |
| scanning analysis technology to detect. | |
| Chemistry | URIT 11FA Urine Reagent Strips |
| URIT 12FA Urine Reagent Strips | |
| Throughput | 480test/hour |
| Memory | 2 million sample data and 100,000 sample pictures. |
| PC Port | PS/2 interface, serial port, Ethernet interface, USB interface |
| Capabilities | Barcode Scanner; Built-in thermal printer or external USB |
| printer | |
| Available Languages on | |
| Screen | Chinese or English |
| Environment | |
| requirement | 15°C-30°C,RH ≤ 80% |
| Specimen ID enter | Manually enter or by bar code reader |
| Dimensions (L × W × H) | 653mm×641mm×570mm |
| Power Source | AC 100V-240V~, 50/60Hz, three-core power supply, good |
| grounding. | |
| Weight | 75kg |
| Calibration | The user can use the URIT urine control materials and |
| calibration test strips to calibrate the instrument |
7 Comparison of technological characteristics with the predicate device
Tahlo 1 Tochnological charactorictics of Propo
7.1 Substantial Equivalence
The URIT 11FA/12FA Urine Reagent Strips and the URIT UC-1800 Automatic Urine Analyzer is substantially equivalent to the Uritest 11G Urine Reagent Strips and the Uritest-500B Urine Analyzer (K082811) except Microalbumin and Creatinine. And the URIT 12FA Urine Reagent Strips and the URIT UC-1800 Automatic Urine Analyzer is substantially equivalent to the Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) and the Mission® U120 Ultra Urine Analyzer(K142391) Microalbumin and Creatinine only
And the URIT UC-1800 Automatic Urine Analyzer is substantially equivalent to AUTION MAX AX-4030 Urinalysis System (K093098) in detecting Specific Gravity, Turbidity and Color detected by Physical Module.
10
| Table 2 Total review of proposed device and predicate devices | |||
|---|---|---|---|
| Device Name | Predicate Device Name | Predicate | |
| 510(K) | |||
| number | Note | ||
| URIT UC-1800 | |||
| Automatic Urine | |||
| Analyzer | Uritest-500B Urine Analyzers | K082811 | Except Microalbumin/Creatinine |
| Mission® U120 Ultra Urine Analyzer | K142391 | Microalbumin/Creatinine only | |
| AUTION MAX AX-4030 Urinalysis | |||
| System | K093098 | Specific Gravity, Turbidity and Color | |
| detected by Physical Module | |||
| URIT 11FA Urine | |||
| Reagent Strips | Uritest 11G Urine Reagent Strips | K082811 | N/A |
| URIT 12FA Urine | |||
| Reagent Strips | Uritest 11G Urine Reagent Strips | K082811 | Except Microalbumin/Creatinine |
| URIT 12FA Urine | |||
| Reagent Strips | Mission® Urinalysis Reagent Strips | ||
| (Microalbumin/Creatinine) | K142391 | Microalbumin/Creatinine only |
11
| Table 3 Comparison with Predicate Devices (1) | ||||||
|---|---|---|---|---|---|---|
| Device | Proposed Device (K232317) | Predicate Device 1(K082811) | Predicate Device 2(K142391) | Predicate Device 3 (K093098) | ||
| Manufacturer | URIT Medical Electronic Co., Ltd. | URIT Medical Electronic Co., Ltd. | Acon Laboratories, Inc. | ARKRAY, Inc. | ||
| Device name | URIT UC-1800 Automatic Urine Analyzer | Uritest-500B Urine Analyzers | Mission® U120 Ultra Urine Analyzer | AUTION MAX AX-4030 Urinalysis System | ||
| Similarities | ||||||
| Classification | Class II (Blood, Glucose and Creatinine analytes raise | |||||
| system to Class II / 510(k) required) | Class II (Blood and Glucose analytes raise system to | |||||
| Class II / 510(k) required) | Class II (Creatinine analytes raise system to | |||||
| Class II / 510(k) required) | Class II (Blood and Glucose analytes raise | |||||
| system to Class II / 510(k) required) | ||||||
| Intended Use | UC-1800 Automatic Urine Analyzer is automated | |||||
| instruments which are intended for professional, in vitro | ||||||
| diagnostic use only. | ||||||
| Depending on the reagent strips being used, the instruments | ||||||
| perform semi-quantitative detection of the following | ||||||
| analytes in urine: ascorbic acid, microalbumin, leukocytes, | ||||||
| creatinine, ketone, urobilinogen, bilirubin, glucose, protein, | ||||||
| specific gravity, blood and pH in urine and for qualitative | ||||||
| determination of nitrite in urine. The urine hydrometer | ||||||
| (optional) can determine the specific gravity, color and | ||||||
| turbidity of urine. Test results may provide reference for | ||||||
| clinical examination and diagnosis. | Uritest-500B urine analyzer is semi-automated, bench | |||||
| top instruments which are intended for prescription, in | ||||||
| vitro diagnostic use only. The instruments perform semi- | ||||||
| quantitative detection of the following analytes in urine: | ||||||
| leukocytes, ketone, nitrite, urobilinogen, bilirubin, | ||||||
| protein, glucose, specific gravity, blood, pH and ascorbic | ||||||
| acid. Test results may provide information regarding the | ||||||
| status of carbohydrate metabolism, kidney and liver | ||||||
| function, acid base balance and bacteriuria. The | ||||||
| instruments use the accompanying check strip for daily | ||||||
| calibration. | The Mission U120 Ultra Urine Analyzer is a | |||||
| urinalysis instrument intended for in vitro | ||||||
| diagnostic use. It is intended for professional use | ||||||
| only at point-of-care locations. The Mission U120 | ||||||
| Ultra Urine Analyzer is intended to read Mission | ||||||
| Urinalysis Reagent strips | ||||||
| (Microalbumin/Creatinine) for the semi | ||||||
| quantitative measurement of Albumin and | ||||||
| Creatinine. These measurements are used to assist | ||||||
| diagnosis for kidney function. | The AX-4030 is an automated urine analyzer that is | |||||
| designed to measure and analyze urine samples | ||||||
| using measurements that include but are not | ||||||
| limited to; Normal, STAT, Control and Check. These | ||||||
| measurements are used to examine the following | ||||||
| analytes; glucose (GLU), protein (PRO), bilirubin | ||||||
| (BIL), urobilinogen (URO), pH (PH), blood (BLD), | ||||||
| ketones (KET), nitrite (NIT) leukocytes (LEU) and | ||||||
| specific gravity (S.G.). In addition, this device is | ||||||
| used only with AUTION Sticks 9EB multi- | ||||||
| parameter test strips. | ||||||
| Data Type | Qualitative, Semi-Quantitative | Qualitative, Semi-Quantitative | Semi-Quantitative | Semi-Quantitative | ||
| Location | Clinical Laboratory | Clinical Laboratory | Clinical Laboratory | Clinical Laboratory | ||
| Medical Device /IVD | Medical Device /IVD | Medical Device /IVD | Medical Device /IVD | Medical Device /IVD | ||
| Indications | For prescription use only. | For prescription use only. | For prescription use only. | For prescription use only. | ||
| Specimen Type | Human Urine | Human Urine | Human Urine | Human Urine | ||
| Analyte | With strips: Glucose, Blood, Urobilinogen, pH, Ketones, | |||||
| Protein, Bilirubin, Nitrite, Leukocyte, Specific Gravity, | ||||||
| Ascorbic acid | Glucose, Blood, Urobilinogen, pH, Ketones, Protein, | |||||
| Bilirubin, Nitrite, Leukocyte, Specific Gravity, Ascorbic | ||||||
| acid | N/A | N/A | ||||
| With strips: Creatinine, Microalbumin | N/A | Creatinine, Microalbumin | N/A | |||
| With Physical module: Specific Gravity, Turbidity and Color | N/A | N/A | Specific Gravity, Turbidity and Color | |||
| Methodology/Principle | Test strips: Reflectance photometer, Measurement of test | |||||
| strips is done by the reflectance photometry method, | ||||||
| using CIS (contact image sensor) image scanning analysis | ||||||
| technology to detect. | ||||||
| Specific Gravity: Refractometer method | ||||||
| Color: Light-transmission measurement | ||||||
| Turbidity: Light-scattering measurement method | Reflectance photometer (Only Test strips) | |||||
| Ingredients that change color in reaction with analytes | Reflectance photometer (Only Test strips) | |||||
| The Mission® U120 Ultra Urine Analyzer utilizes | ||||||
| a CMOS image sensor to measure the intensity of | ||||||
| light. The frequency of the light is determined by | ||||||
| the LED light source. | (without Test Strips) | |||||
| Specific gravity: Reflection refractometry | ||||||
| Color hue: Light-transmission measurement | ||||||
| Turbidity: Light-scattering measurement method | ||||||
| Specimen ID enter | Manually enter or by bar code reader | Manually enter or by bar code reader | Manually enter or by bar code reader | Barcode Reader | ||
| Environment | ||||||
| requirement | 15°C-30°C,RH ≤ 80% | 15°C-30°C,RH ≤ 80% | 15-30°C (59-86°F); 20-80% Relative Humidity | |||
| (noncondensing) | Temperature: 10-30°C,Humidity: 20-80% RH(No | |||||
| condensation ) |
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12
| Table 4 Comparison with Predicate Devices (2) | ||||
|---|---|---|---|---|
| Device | Proposed Device (K232317) | Predicate Device 1(K082811) | Predicate Device 2(K142391) | Predicate Device 3(K142392) |
| Manufacturer | URIT Medical Electronic Co., Ltd. | URIT Medical Electronic Co., Ltd. | Acon Laboratories, Inc. | ARKRAY, Inc. |
| Device name | URIT UC-1800 Automatic Urine Analyzer | Uritest-500B Urine Analyzers | Mission® U120 Ultra Urine Analyzer | AUTION MAX AX-4030 Urinalysis |
| System | ||||
| Differences | ||||
| Chemistry | URIT 11FA Urine Reagent Strips | |||
| URIT 12FA Urine Reagent Strips | Uritest 11G Urine Reagent Strips | Mission® Urinalysis Reagent Strips | ||
| (Microalbumin/ Creatinine) | None | |||
| Available | ||||
| Languages on | ||||
| Screen | Chinese or English | Chinese or English | English and Spanish | English |
| Dimensions | ||||
| (L × W × H) | 653mm×641mm×570mm | 390 mm x 340 mm ×290 mm | 26.0 (L) x 15.0 (W) x 17.5 (H) cm | 530 (w) x 530(d) x 530 (h)(mm) |
| Power Source | AC 100V-240V~, 50/60Hz, | |||
| three-core power supply, good grounding. | AC100-240V, 50/60Hz Input: 61VA | 100- 240 VAC (adapter), (50-60Hz± 1HZ)6 | ||
| AA batteries with 100 tests/6 new batteries; | 100-240 VAC, 50/60 Hz | |||
| Weight | 75kg | 6.5 Kg | ≤1.66 kg (3.65 lbs.) without batteries or | |
| power supply | 41Kg (including the Sampler unit 4kg) | |||
| PC Port | PS/2 interface, serial port, | |||
| Ethernet interface, USB interface | RS 232 port. | Standard RS232C Port (cable not included), | ||
| USB Port (cable not included); | ||||
| (Not connected to PC) Bluetooth Wireless | RS-232C/ Ethernet | |||
| Capabilities | Barcode Scanner | |||
| Built-in thermal printer or external USB printer | Internal or external Printer | Internal thermal printer | ||
| Barcode reader Connector | ||||
| External printer (optional) | ||||
| Barcode reader (optional) | ||||
| RJ45 Ethernet; (optional) | Built-in printer | |||
| Calibration | The user can use the URIT urine control materials and | |||
| calibration test strips to calibrate the instrument | Self-calibration---white calibration bar | The Mission® U120 Ultra Urine Analyzer | ||
| performs an automatic calibration each time | ||||
| a test is run. | N/A | |||
| Throughput | 480test/hour | 500 tests/hour | Single Test Mode: 55 tests/hour. | |
| Continuous Test Mode: 120 tests/hour. | 225 samples/hour | |||
| Memory | 2 million sample data and 100,000 sample pictures | 1,000 results | Last 2000 test results | 2500 tests |
13
No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China
Characteristic of the URIT 11FA/12FA Urine Reagent Strips are compared with the Uritest 11G Urine Reagent Strips (K082811) for instrument reading in Table 5 to Table 7
| Device | Proposed Device | Predicate Device 1 |
|---|---|---|
| Manufacturer | URIT Medical Electronic Co., Ltd. | URIT Medical Electronic Co., Ltd. |
| 510K number | K232317 | K082811 |
| Device name | URIT 11FA Urine Reagent Strips | |
| URIT 12FA Urine Reagent Strips | Uritest 11G Urine Reagent Strips | |
| Classification | Class II (Blood, Glucose and Creatinine | |
| analytes raise system to Class II / 510(k) | ||
| required) | Class II (Blood and Glucose analytes raise | |
| system to Class II / 510(k) required) | ||
| Intended Use | The URIT 11FA urine reagent strips provide | |
| semi-quantitative tests for ascorbic acid, | ||
| leukocytes, ketone, urobilinogen, bilirubin, | ||
| glucose, protein, specific gravity, blood and | ||
| pH in urine and for qualitative determination | ||
| of nitrite in urine. The URIT 11FA urine | ||
| reagent strips are for use with the UC-1800 | ||
| Automatic Urine Analyzer and are for | ||
| professional, in vitro diagnostic use only. | ||
| The URIT 12FA urine reagent strips provide | ||
| semi-quantitative tests for microalbumin, | ||
| leukocytes, creatinine, ketone, urobilinogen, | ||
| bilirubin, glucose, protein, specific gravity, | ||
| blood and pH in urine and for qualitative | ||
| determination of nitrite in urine. The URIT | ||
| 12FA urine reagent strips are for use with the | ||
| UC-1800 Automatic Urine Analyzer and are | ||
| for professional, in vitro diagnostic use only. | Uritest 11G urine reagent strips provide | |
| semi-quantitative tests for Ascorbic acid, | ||
| Nitrite, Leukocyte, Ketone, Urobilinogen, | ||
| Bilirubin, Glucose, Protein, Blood, Specific | ||
| Gravity, PH in urine. The Uritest 11 G urine | ||
| reagent strips are for use with Uritest-500B | ||
| urine analyzer and are for prescription, in | ||
| vitro diagnostic use only. Test results may | ||
| provide information regarding the status of | ||
| carbohydrate metabolism, kidney and liver | ||
| function, acid-base balance and bacteriuria | ||
| The strips are read instrumentally by the | ||
| Uritest-500B Urine Analyzers | ||
| Indications | Professional in vitro diagnostic use | Same |
| Analytes | URIT 11FA/12FA Urine Reagent Strips: | |
| Nitrite, Leukocyte, Ketone, Urobilinogen, | ||
| Bilirubin, Glucose, Protein, Blood, Specific | ||
| Gravity, PH | ||
| URIT 11FA Urine Reagent Strips also provide | ||
| the detection of Ascorbic acid, | ||
| While URIT 12FA Urine Reagent Strips | ||
| provide the detection of microalbumin and | ||
| creatinine (Predicated with K142391) | Ascorbic acid, Nitrite, Leukocyte, Ketone, | |
| Urobilinogen, Bilirubin, Glucose, Protein, | ||
| Blood, Specific Gravity, PH | ||
| Specimen | Human Urine | Same |
| Architecture | Firm plastic, dry reagent strips | Same |
| Table 5 Comparison with Predicate Devices-Reagent strips (1) | |||
|---|---|---|---|
| Device | Proposed Device | Predicate Device 1 | |
| Manufacturer | URIT Medical Electronic Co., Ltd. | URIT Medical Electronic Co., Ltd. | |
| 510K number | K232317 | K082811 | |
| Device name | URIT 11FA Urine Reagent Strips | ||
| URIT 12FA Urine Reagent Strips | Uritest 11G Urine Reagent Strips | ||
| Classification | Class II (Blood, Glucose and Creatinine analytes raise system to Class II / | ||
| 510(k) required) | Class II (Blood and Glucose analytes raise system to | ||
| Class II / 510(k) required) | |||
| Test Principle | Ingredients that change color in reaction with analytes | Same | |
| Blank block | |||
| (calibrator) | The distribution of urine on the test block and the color of the urine itself will | ||
| generally cause errors to the measurement results. The purpose of setting the | |||
| blank block is to eliminate these factors that may cause error, and the same blank | |||
| block is used for each project. | Same | ||
| Ascorbic acid | Based on the principle of Tillman's Reagent, Ascorbic acid can reduce the dye from | ||
| blue to red. The purpose of the determination of this project is to provide the user | |||
| with the content of Ascorbic acid in the sample to determine its possible | |||
| interference. | Same | ||
| Nitrite | In this reaction, nitrate is reduced to nitrite by Gram-negative bacteria in the urine, | ||
| the nitrite will react with arsanilic acid to form a diazonium compound, and the | |||
| diazonium compound will be combined with naphthylethylenediamine | |||
| dihydrochloride to show a pink color. | Same | ||
| Microalbumin | Based on the dye-binding method, microalbumin can react with the dye to form a | ||
| pink complex and generate produce a color change, which is particularly sensitive | |||
| to the reaction of albumin. | None | ||
| Leukocyte | Based on the principle of esterase method, granulosa cytoplasm contains esterase | ||
| which can hydrolyze a 3-hydroxyindoxyl ester substrate, release phenol and react | |||
| with diazo reagent to generate purple-red compounds. | Same | ||
| Creatinine | Based on the principle of displacement reaction, creatinine can displace the dye in | ||
| the metal chloride-acid dye complex, and the color will change from green to yellow | None | ||
| Ketone | Based on the principle of sodium nitro prussiate method, sodium nitroprusside can | ||
| interact with ketone (acetoacetate) under alkaline conditions to become purple, | |||
| especially acetoacetate is particularly sensitive to this. | Same | ||
| Urobilinogen | Based on the principle of azo-binding method, urobilinogen is coupled with | ||
| diazonium salt under strong acid conditions to form carmine pigment. | Same | ||
| Bilirubin | Based on the principle of azo-coupling method,2,4-dichloroaniline diazonium salt | ||
| can react specifically with bilirubin, and produce different colors depending on the | |||
| concentration of bilirubin. | Same | ||
| Glucose | Based on the reaction principle of glucose oxidase method, glucose oxidase can | ||
| specifically oxidize β-D-glucose to generate glucuronic acid and hydrogen peroxide | |||
| that will oxidize the indicator under the action of peroxidase and show a purple- | |||
| red color. | Same | ||
| Protein | Based on the principle of protein error method of dye binding, the protein can | ||
| combine with the dye to form a complex that produce a color change, especially the | |||
| response to albumin is more sensitive than that of globulin, hemoglobin, Bence- | |||
| Jone protein and mucin. | Same | ||
| Blood | Based on the principle of hemoglobin contact activity method, the decomposition | ||
| of peroxides can be catalyzed through the peroxidase-like action of hemoglobin, so | |||
| that tetramethylbenzidine is oxidized and colored. | Same | ||
| Specific Gravity | This test contains a detergent and Bromthymol blue that indicates the presence of | ||
| ionic constituents in the urine by changing color from green to yellow. | Same | ||
| PH | The pH value within the range from 5.0 to 9.0 is measured by pH indicator, and the | ||
| pH value of fresh urine of normal people is within the range from 5.5 to 7.0. | Same | ||
| Detection Range | Ascorbic Acid (10-100) mg/dL | Same | |
| Nitrite (+/-) | Same | ||
| Leukocytes (15-500)leu/mcL | Same | ||
| Ketone (5-80) mg/dL | Same | ||
| Urobilinogen (2-8)EU/dL | Same | ||
| Bilirubin (0.5-6.0) mg/dL | Same | ||
| Glucose (50-1000) mg/dL | Same | ||
| Protein (15-300)mg/dL | Same | ||
| Blood (10-200) ery/mcL | Same | ||
| Specific Gravity 1.005-1.030 | Same | ||
| pH 5.0-9.0 | Same |
14
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No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China
Characteristic of the URIT 12FA Urine Reagent Strips in detecting Microalbumin and creatinine are compared with the Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) (K142391) read by Mission®U120 Ultra Urine Analyzer in Table 7.
| Device | Proposed Device | Predicate Device 2 |
|---|---|---|
| Manufacturer | URIT Medical Electronic Co., Ltd. | Acon Laboratories, Inc. |
| 510K number | K232317 | K142391 |
| Device name | URIT 12FA Urine Reagent Strips | |
| (Only Microalbumin/Creatinine) | Mission® Urinalysis Reagent Strips | |
| (Microalbumin/Creatinine) | ||
| Classification | Class II | Class II |
| Similarities | ||
| Intended Use | The URIT 12FA urine reagent strips provide semi- | |
| quantitative tests for microalbumin , leukocytes, | ||
| creatinine , ketone, urobilinogen, bilirubin, | ||
| glucose, protein, specific gravity, blood and pH in | ||
| urine and for qualitative determination of nitrite | ||
| in urine. The URIT 12FA urine reagent strips are | ||
| for use with the UC-1800 Automatic Urine | ||
| Analyzer and are for professional, in vitro | ||
| diagnostic use only. | The Mission Urinalysis Reagent strips | |
| (Microalbumin/Creatinine) are intended for the | ||
| semi quantitative measurement of albumin and | ||
| creatinine in urine samples using the Mission | ||
| U120 Ultra Urine Analyzer. These | ||
| measurements are used to assist diagnosis for | ||
| kidney function. It is intended for professional | ||
| use only at point-of-care locations. | ||
| The strips are read instrumentally by the | ||
| Mission® U120 Ultra Urine Analyzer | ||
| Indications | Professional in vitro diagnostic use | Professional use in point-of-care urine testing |
| Analytes | Microalbumin and Creatinine | Microalbumin and creatinine |
| Specimen | Human Urine | Human Urine |
| Architecture | Firm plastic, dry reagent strips | Plastic strips affixed with two separate reagent |
| areas. | ||
| Differences | ||
| Test Principle | Ingredients that change color in reaction with | |
| analytes | Intensity of the light reflected from the reagent | |
| areas of a urinalysis reagent strip. | ||
| Storage | Store at 2°C-30°C | Store at 15°C-30°C |
| Microalbumin | ||
| Detection | ||
| Methodology | Based on the dye-binding method, microalbumin | |
| can react with the dye to form a pink complex | ||
| and generate produce a color change, which is | ||
| particularly sensitive to the reaction of albumin. | This test is based on dye binding using a high | |
| affinity sulfone phthalein dye. At a constant pH, | ||
| the development of any blue color is due to the | ||
| presence of albumin. The resulting color ranges | ||
| from pale green to aqua blue | ||
| Creatinine | ||
| Detection | ||
| Methodology | Based on the principle of displacement reaction, | |
| creatinine can displace the dye in the metal | ||
| chloride-acid dye complex, and the color will | ||
| change from green to yellow. | This test is based on the peroxidase-like activity | |
| of a copper creatinine complex that catalyzes the | ||
| reaction of diisopropylbenzene dihydroperoxide | ||
| and 3,3',5,5'- tetramethylbenzidine. The | ||
| resulting color ranges from orange through | ||
| green to blue | ||
| Detection | ||
| Range | Microalbumin (10-150) mg/L | Detects albumin between 10-150mg/L |
| Creatinine(10-300)mg/dL | Detects creatinine between 10-300 mg/dL (0.9 - | |
| 26.5 mmol/L) |
Table 7 Comparison with Predicato novicos.Roggont ctrine (2)
Therefore, it can be concluded that the subject device and the proposed device are substantially equivalent.
16
8 Summary of Non-Clinical Testing
8.1 Analytical performance
Precision /Reproducibility a
The Repeatability (With-in Run) Precision of the URIT UC-1800 Automatic Urine Analyzer was evaluated by using negative urines and spiked urines of known concentrations for each analyte. Each sample was tested in 20 replicates across 3 instruments with the 3lots of URIT 11FA Urine Reagent Strips and 3lots of URIT 12FA Urine Reagent Strips in each instrument for a total of 60 measurements at each concentrations for all tests had 60 of 60 (100%) match at ± one color block. The results are summarized in Table 8 to Table 11.
| Test | Expected Value | |||||
|---|---|---|---|---|---|---|
| Ascorbic acid (mg/dL) | -(0) | +-(10) | +1(25) | +2(50) | +3(100) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Nitrite | - (Negative) | + (Positive) | ||||
| Exact agreement | 100% (60/60) | 100% (60/60) | ||||
| ± 1 color block | 100% (60/60) | 100% (60/60) | ||||
| Conclusion | Qualified | Qualified | ||||
| Leukocyte(leu/μL) | -(0) | +-(15) | +1(70) | +2(125) | +3(500) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Ketone (mg/dL) | -(0) | +-(5) | +1(15) | +2(40) | +3(80) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Urobilinogen (EU/dL) | Normal | +1(2.0) | +2(4.0) | +3(8.0) | ||
| Exact agreement | 100% (60/60) | 100% (60/60) | 96.7% (58/60) | 100% (60/60) | ||
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Bilirubin (mg/dL) | -(0) | +1(0.5) | +2(2.0) | +3(6.0) | ||
| Exact agreement | 100% (60/60) | 100% (60/60) | 96.7% (58/60) | 100% (60/60) | ||
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Glucose(mg/dL) | -(0) | +-(50) | +1(100) | +2(250) | +3(500) | +4(1000) |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Protein(mg/dL) | -(0) | +-(15) | +1(30) | +2(100) | +3(300) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 93.3% (56/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Exact agreement | 100% (60/60) | 96.7% (58/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Test | Expected Value | |||||
| Blood(CELL/µL) | -(0) | +-(10) | +1(25) | +2(80) | +3(200) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 98.3% (59/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 96.7% (58/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| pH | 8.0 | 8.5 | 9.0 | |||
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | |||
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | |||
| Conclusion | Qualified | Qualified | Qualified |
Table 8 Summary of Repeatability (With-in Run) Precision of URIT 11FA Urine Reagent Strips
17
Table 9 Summary of Repeatability (With-in Run) Precision of URIT 12FA Urine Reagent Strips
| Test | Expected Value | |||||
|---|---|---|---|---|---|---|
| Nitrite | - (Negative) | + (Positive) | ||||
| Exact agreement | 100% (60/60) | 100% (60/60) | ||||
| ± 1 color block | 100% (60/60) | 100% (60/60) | ||||
| Conclusion | Qualified | Qualified | ||||
| Leukocyte(leu/µL) | -(0) | +-(15) | +1(70) | +2(125) | +3(500) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Ketone (mg/dL) | -(0) | +-(5) | +1(15) | +2(40) | +3(80) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 96.7% (58/60) | 96.7% (58/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Urobilinogen (EU/dL) | Normal | +1(2.0) | +2(4.0) | +3(8.0) | ||
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | ||
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Bilirubin (mg/dL) | -(0) | +1(0.5) | +2(2.0) | +3(6.0) | ||
| Exact agreement | 100% (60/60) | 98.3% (59/60) | 91.7% (55/60) | 100% (60/60) | ||
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Glucose(mg/dL) | -(0) | +-(50) | +1(100) | +2(250) | +3(500) | +4(1000) |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Protein(mg/dL) | -(0) | +-(15) | +1(30) | +2(100) | +3(300) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 93.3% (56/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
18
| No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China | ||||||
|---|---|---|---|---|---|---|
| Test | Expected Value | |||||
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Blood(CELL/µL) | -(0) | +-(10) | +1(25) | +2(80) | +3(200) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| pH | 8.0 | 8.5 | 9.0 | |||
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | |||
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | |||
| Conclusion | Qualified | Qualified | Qualified | |||
| Microalbumin | 10mg/L | 30mg/L | 80mg/L | 150mg/L | ||
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | ||
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Creatinine | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified |
URIT MEDICAL ELECTRONIC CO., LTD. District High-Tech Zone Guilin Gr
Table 10 Summary of Repeatability (With-in Run) Precision of Physical Module Item Turbidity
| Test | Expected Value | |||
|---|---|---|---|---|
| Turbidity | Clear | Micro turbid | Turbid | Very turbid |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 Block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified |
Table 11 Summary of Repeatability (With-in Run) Precision of Physical Module Item Color
| Test | Color | Exact agreement | Conclusion |
|---|---|---|---|
| Expected Value | Colorless | 100% (60/60) | Qualified |
| Brown | 100% (60/60) | Qualified | |
| Yellow | 100% (60/60) | Qualified | |
| Red | 100% (60/60) | Qualified | |
| Green | 100% (60/60) | Qualified | |
| Other-Orange | 100% (60/60) | Qualified | |
| Other-Blue | 100% (60/60) | Qualified | |
| Other-Purple | 100% (60/60) | Qualified |
The Reproducibility (Between-Run) Precision of the URIT UC-1800 Automatic Urine Analyzer was evaluated by using negative urines and spiked urines of known concentrations for each analyte. Each sample was tested for 20days with 2 runs per day, in 1 time per run in 3 sites, each site with 1 instrument, totally the test performed across 3 instruments with the 3lots of URIT 11FA Urine Reagent Strips and 3lots of URIT 12FA Urine Reagent Strips in each instrument by 3 operators, each operator performing the test for 6-7 days, for a total of 120 measurements at each concentration were tested. All
19
No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China
concentrations for all tests had 120 of 120 (100%) match at ± one color block. The results are summarized in Table 12 to Table 15.
Table 12 Summary of Reproducibility (Between-Run) Precision of URIT 11FA Urine Reagent Strips
| Test | Expected Value | |||||
|---|---|---|---|---|---|---|
| Ascorbic acid (mg/dL) | -(0) | +-(10) | +1(25) | +2(50) | +3(100) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 94.2% (113/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Nitrite | - (Negative) | + (Positive) | ||||
| Exact agreement | 100% (120/120) | 100% (120/120) | ||||
| ± 1 color block | 100% (120/120) | 100% (120/120) | ||||
| Conclusion | Qualified | Qualified | ||||
| Leukocyte(leu/μL) | -(0) | +-(15) | +1(70) | +2(125) | +3(500) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Ketone (mg/dL) | -(0) | +-(5) | +1(15) | +2(40) | +3(80) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Urobilinogen (EU/dL) | Normal | +1(2.0) | +2(4.0) | +3(8.0) | ||
| Exact agreement | 100% (120/120) | 100% (120/120) | 98.3% (118/120) | 100% (120/120) | ||
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Bilirubin (mg/dL) | -(0) | +1(0.5) | +2(2.0) | +3(6.0) | ||
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | ||
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Glucose(mg/dL) | -(0) | +-(50) | +1(100) | +2(250) | +3(500) | +4(1000) |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Protein(mg/dL) | -(0) | +-(15) | +1(30) | +2(100) | +3(300) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 99.2% (119/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Blood(CELL/μL) | -(0) | +-(10) | +1(25) | +2(80) | +3(200) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 95% (114/120) | 97.5% (117/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 99.2% (119/120) | 100% (120/120) |
| Test | Expected Value | |||||
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| pH | 8.0 | 8.5 | 9.0 | |||
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | |||
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | |||
| Conclusion | Qualified | Qualified | Qualified |
20
Table 13 Summary of Reproducibility (Between-Run) Precision of URIT 12FA Urine Reagent Strips
| Test | Expected Value | |||||
|---|---|---|---|---|---|---|
| Nitrite | - (Negative) | + (Positive) | ||||
| Exact agreement | 100% (120/120) | 100% (120/120) | ||||
| ± 1 color block | 100% (120/120) | 100% (120/120) | ||||
| Conclusion | Qualified | Qualified | ||||
| Leukocyte(leu/µL) | -(0) | +-(15) | +1(70) | +2(125) | +3(500) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Ketone (mg/dL) | -(0) | +-(5) | +1(15) | +2(40) | +3(80) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Urobilinogen (EU/dL) | Normal | +1(2.0) | +2(4.0) | +3(8.0) | ||
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | ||
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Bilirubin (mg/dL) | -(0) | +1(0.5) | +2(2.0) | +3(6.0) | ||
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | ||
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Glucose(mg/dL) | -(0) | +-(50) | +1(100) | +2(250) | +3(500) | +4(1000) |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Protein(mg/dL) | -(0) | +-(15) | +1(30) | +2(100) | +3(300) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Blood(CELL/µL) | -(0) | +-(10) | +1(25) | +2(80) | +3(200) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 95.8% (115/120) | 99.2% (119/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified |
21
| Test | Expected Value | |||||
|---|---|---|---|---|---|---|
| pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| pH | 8.0 | 8.5 | 9.0 | |||
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | |||
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | |||
| Conclusion | Qualified | Qualified | Qualified | |||
| Microalbumin | 10 mg/L | 30 mg/L | 80 mg/L | 150 mg/L | ||
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | ||
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | ||
| Conclusion | Qualified | Qualified | Qualified | Qualified | ||
| Creatinine | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified |
Table 14 Summary of Reproducibility (Between- Run) Precision of Physical Module Item Turbidity
| Test | Expected Value | |||
|---|---|---|---|---|
| Turbidity | Clear | Micro turbid | Turbid | Very turbid |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 Block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified |
Table 15 Summary of Reproducibility (Between- Run) Precision of Physical Module Item Color
| Test | Color | Exact agreement | Conclusion |
|---|---|---|---|
| Expected Value | Colorless | 100% (120/120) | Qualified |
| Brown | 100% (120/120) | Qualified | |
| Yellow | 100% (120/120) | Qualified | |
| Red | 100% (120/120) | Qualified | |
| Green | 100% (120/120) | Qualified | |
| Other-Orange | 100% (120/120) | Qualified | |
| Other-Blue | 100% (120/120) | Qualified | |
| Other-Purple | 100% (120/120) | Qualified |
b Linearity/assay reportable range
The assay reportable range was evaluated by measuring the samples containing known concentrations of all measurement blocks. Prepare the reference solutions according to the marked values of concentration for each item on the URIT 11FA and 12FA urine reagent strips, and conduct linear range/reportable range experiments on the instrument with the reference solutions. Test each reference solution on three UC-1800 machines of reagent strips. Repeat the test for each batch of test strip for 21 times on each instrument.
The results of assay reportable range of URIT 11FA Urine Reagent Strips and URIT 12FA Urine Reagent Strips are summarized as Table 16 to Table 18 show below. The Summary of Reportable Results of URIT 11FA Urine Reagent Strips and URIT 12FA Urine Reagent Strips are summarized as Table 19 show below.
22
| Table 16 Summary of Linearity of URIT 11/12FA Urine Reagent Strips -common analytes | |||||
|---|---|---|---|---|---|
| URIT 11/12 FA Urine Reagent Strips (Common Item) | |||||
| Qualitative | Semi-Quantitative | Concentration/Level | Agreement at same | Agreement within + /- one | |
| Analyte | Rank | Rank | Tested | block | block |
| Leukocyte | - | 0 | 0 leu/mcL | 100% (63/63) | 100% (63/63) |
| +/- | 15 | 15 leu/mcL | 100% (63/63) | 100% (63/63) | |
| +1 | 70 | 70 leu/mcL | 100% (63/63) | 100% (63/63) | |
| +2 | 125 | 125 leu/mcL | 100% (63/63) | 100% (63/63) | |
| +3 | 500 | 500 leu/mcL | 100% (63/63) | 100% (63/63) | |
| Ketones | - | 0 | 0 mg/dL | 100% (63/63) | 100% (63/63) |
| +/- | 5 | 5 mg/dL | 100% (63/63) | 100% (63/63) | |
| +1 | 15 | 15 mg/dL | 100% (63/63) | 100% (63/63) | |
| +2 | 40 | 40 mg/dL | 100% (63/63) | 100% (63/63) | |
| +3 | 80 | 80 mg/dL | 100% (63/63) | 100% (63/63) | |
| Urobilinogen | Normal | Normal | Normal | 100% (63/63) | 100% (63/63) |
| +1 | 2.0 | 2.0 mg/dL | 100% (63/63) | 100% (63/63) | |
| +2 | 4.0 | 4.0 mg/dL | 100% (63/63) | 100% (63/63) | |
| +3 | 8.0 | 8.0 mg/dL | 100% (63/63) | 100% (63/63) | |
| Bilirubin | - | 0 | 0 mg/dL | 100% (63/63) | 100% (63/63) |
| +1 | 0.5 | 0.5 mg/dL | 100% (63/63) | 100% (63/63) | |
| +2 | 2.0 | 2.0 mg/dL | 100% (63/63) | 100% (63/63) | |
| +3 | 6.0 | 6.0 mg/dL | 100% (63/63) | 100% (63/63) | |
| Glucose | - | 0 | 0 mg/dL | 100% (63/63) | 100% (63/63) |
| +/- | 50 | 50 mg/dL | 100% (63/63) | 100% (63/63) | |
| +1 | 100 | 100 mg/dL | 100% (63/63) | 100% (63/63) | |
| +2 | 250 | 250 mg/dL | 100% (63/63) | 100% (63/63) | |
| +3 | 500 | 500 mg/dL | 100% (63/63) | 100% (63/63) | |
| +4 | 1000 | 1000 mg/dL | 100% (63/63) | 100% (63/63) | |
| Protein | - | 0 | 0 mg/dL | 100% (63/63) | 100% (63/63) |
| +/- | 15 | 15 mg/dL | 100% (63/63) | 100% (63/63) | |
| +1 | 30 | 30 mg/dL | 100% (63/63) | 100% (63/63) | |
| +2 | 100 | 100 mg/dL | 100% (63/63) | 100% (63/63) | |
| +3 | 300 | 300 mg/dL | 100% (63/63) | 100% (63/63) | |
| Blood | - | 0 | 0 ery/mcL | 100% (63/63) | 100% (63/63) |
| +/- | 10 | 10 ery/mcL | 100% (63/63) | 100% (63/63) | |
| +1 | 25 | 25 ery/mcL | 100% (63/63) | 100% (63/63) | |
| +2 | 80 | 80 ery/mcL | 100% (63/63) | 100% (63/63) | |
| +3 | 200 | 200 ery/mcL | 100% (63/63) | 100% (63/63) | |
| Specific | |||||
| Gravity | N/A | 1.005 | 1.005 | 100% (63/63) | 100% (63/63) |
| 1.010 | 1.010 | 100% (63/63) | 100% (63/63) | ||
| 1.015 | 1.015 | 100% (63/63) | 100% (63/63) | ||
| 1.020 | 1.020 | 100% (63/63) | 100% (63/63) | ||
| 1.025 | 1.025 | 100% (63/63) | 100% (63/63) | ||
| 1.030 | 1.030 | 100% (63/63) | 100% (63/63) | ||
| pH | N/A | 5.0 | 5.0 | 100% (63/63) | 100% (63/63) |
| URIT 11/12 FA Urine Reagent Strips (Common Item) | |||||
| Qualitative | |||||
| Rank | Semi-Quantitative | ||||
| Rank | Concentration/Level | ||||
| Tested | Agreement at same | ||||
| block | Agreement within +/- one | ||||
| block | |||||
| Analyte | 6.0 | 6.0 | 100% (63/63) | 100% (63/63) | |
| 6.5 | 6.5 | 100% (63/63) | 100% (63/63) | ||
| 7.0 | 7.0 | 100% (63/63) | 100% (63/63) | ||
| 7.5 | 7.5 | 100% (63/63) | 100% (63/63) | ||
| 8.0 | 8.0 | 100% (63/63) | 100% (63/63) | ||
| 8.5 | 8.5 | 100% (63/63) | 100% (63/63) | ||
| 9.0 | 9.0 | 100% (63/63) | 100% (63/63) |
23
Table 17 Summary of Linearity of URIT 11FA Urine Reagent Strips
| URIT 11 FA Urine Reagent Strips | |||||
|---|---|---|---|---|---|
| Analyte | Qualitative | ||||
| Rank | Semi-Quantitative | ||||
| Rank | Concentration/Level | ||||
| Tested | Agreement at same | ||||
| block | Agreement within +/- one | ||||
| block | |||||
| Ascorbic | |||||
| acid | - | 0 | 0mg/dL | 100% (63/63) | 100% (63/63) |
| +1 | 10 | 10mg/dL | 100% (63/63) | 100% (63/63) | |
| +2 | 25 | 25mg/dL | 100% (63/63) | 100% (63/63) | |
| +3 | 50 | 50mg/dL | 100% (63/63) | 100% (63/63) | |
| +4 | 100 | 100mg/dL | 100% (63/63) | 100% (63/63) |
Table 18 Summary of Report range of URIT 12FA Urine Reagent Strips
| URIT 12FA Urine Reagent Strips (Microalbumin & Creatinine) | ||||
|---|---|---|---|---|
| Analyte | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block | Agreement within +/- one block |
| Microalbumin | 10 | 10mg/L | 100% (63/63) | 100% (63/63) |
| 30 | 30mg/L | 100% (63/63) | 100% (63/63) | |
| 80 | 80mg/L | 100% (63/63) | 100% (63/63) | |
| 150 | 150mg/L | 100% (63/63) | 100% (63/63) | |
| Creatinine | 10 | 10mg/dL | 100% (63/63) | 100% (63/63) |
| 50 | 50mg/dL | 100% (63/63) | 100% (63/63) | |
| 100 | 100mg/dL | 100% (63/63) | 100% (63/63) | |
| 200 | 200mg/dL | 100% (63/63) | 100% (63/63) | |
| 300 | 300mg/dL | 100% (63/63) | 100% (63/63) |
Table 19 Summary of Reportable Results of URIT 11/12FA Urine Reagent Strips
| Item | URIT Urine Reagent Strips | |
|---|---|---|
| 11FA | 12FA | |
| Ascorbic acid | 0, 10, 25, 50, 100 mg/dL | |
| -, +/-, +1, +2, +3 | N/A | |
| Microalbumin | N/A | 10,30,80,150 mg/L |
| Leukocyte | 0, 15, 70, 125, 500 leu/mcL | |
| -, +/-, +1, +2, +3 | ||
| Creatinine | N/A | 10,50,100,200,300 mg/dL |
| Ketone | 0,5,15,40,80 mg/dL | |
| -, +/-, +1, +2, +3 | ||
| Urobilinogen | Normal,2.0,4.0,8.0 EU/dL | |
| Normal, +1, +2, +3 |
24
| Item | URIT Urine Reagent Strips | |
|---|---|---|
| 11FA | 12FA | |
| Bilirubin | 0,0.5,2.0,6.0mg/dL | |
| -, +1, +2, +3 | ||
| Glucose | 0,50,100,250,500,1000 mg/dL | |
| -, +/-, +1, +2, +3, +4 | ||
| Protein | 0,15,30,100,300 mg/dL | |
| -, +/-, +1, +2, +3 | ||
| Blood | 0, 10,25,80,200 ery/mcL | |
| -, +/-, +1, +2, +3 | ||
| Specific Gravity | 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 | |
| pH | 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 |
c
The results of Analytical Sensitivity of URIT 11FA Urine Reagent Strips and URIT 12FA Urine Reagent Strips are summarized as Table 20.
| Table 20 Summary of Analytical Sensitivity of Urine Reagent Strips | ||
|---|---|---|
| Item | URIT Urine Reagent Strips | |
|---|---|---|
| 11FA | 12FA | |
| Ascorbic acid | 8~10mg/dL | N/A |
| Nitrite | 0.1-0.2mg/dL | |
| Microalbumin | N/A | 20-30mg/L |
| Leukocyte | 10~15leu/mcL | |
| Creatinine | N/A | 25~50mg/dL |
| Ketone | 4~5mg/dL | |
| Urobilinogen | 1~2EU/dL | |
| Bilirubin | 0.4~0.5mg/dL | |
| Glucose | 40~50mg/dL | |
| Protein | 10~15mg/dL | |
| Blood | 5~10ery/mcL |
Analytical sensitivity is not applicable for both strips in detection of pH and Specific Gravity
The results of Critical value of URIT 11FA Urine Reagent Strips and URIT 12FA Urine Reagent Strips are summarized as Table 21 show.
| Table 21 Summary of Critical value of Urine Reagent Strips | ||||
|---|---|---|---|---|
| Analyte | Concentration | Critical value | Agreement rate% | |
| 11FA | 12FA | |||
| Ascorbic acid | 25 (1+) | 12 mg/dL | 76 | |
| Ascorbic acid | 50 (2+) | 32 mg/dL | 89 | N/A |
| Ascorbic acid | 100 (3+) | 72 mg/dL | 66 | |
| Microalbumin | 8 | 5.2mg/dL | N/A | 88 |
| Microalbumin | 15 | 11.3mg/dL | 79 | |
| Leukocyte | 70(1+) | 38 leu/mcL | 92 | 74 |
| Leukocyte | 125(2+) | 88 leu/mcL | 85 | 64 |
| Leukocyte | 500 (3+) | 337 leu/mcL | 77 | 69 |
| Creatinine | 100 | 74mg/dL | 77 | |
| Creatinine | 200 | 142mg/dL | N/A | 75 |
| Creatinine | 300 | 239mg/dL | 79 |
25
| Analyte | Concentration | Critical value | Agreement rate% | |
|---|---|---|---|---|
| Ketone | 15 (1+) | 8 mg/dL | 82 | 74 |
| Ketone | 40 (2+) | 25 mg/dL | 82 | 76 |
| Ketone | 80(3+) | 63 mg/dL | 72 | 71 |
| Urobilinogen | 4 (2+) | 1.8 EU/dL | 81 | 77 |
| Urobilinogen | 8 (3+) | 4.5 EU/dL | 71 | 74 |
| Bilirubin | 2(2+) | 1.3 mg/dL | 88 | 78 |
| Bilirubin | 6(3+) | 3 mg/dL | 79 | 73 |
| Glucose | 100 (1+) | 75 mg/dL | 86 | 73 |
| Glucose | 250 (2+) | 165 mg/dL | 77 | 74 |
| Glucose | 500 (3+) | 360 mg/dL | 66 | 76 |
| Glucose | 1000 (4+) | 735 mg/dL | 71 | 74 |
| Protein | 30 (1+) | 21 mg/dL | 77 | 83 |
| Protein | 100 (2+) | 65 mg/dL | 75 | 70 |
| Protein | 300 (3+) | 180 mg/dL | 79 | 70 |
| Blood | 25 (1+) | 16 ery/mcL | 79 | 77 |
| Blood | 80 (2+) | 65 ery/mcL | 77 | 79 |
| Blood | 200 (3+) | 130 ery/mcL | 79 | 71 |
| pH | 5.5 | 5.2 | 83 | 73 |
| pH | 6 | 5.8 | 86 | 79 |
| pH | 6.5 | 6.3 | 82 | 77 |
| pH | 7.0 | 6.7 | 81 | 78 |
| pH | 7.5 | 7.3 | 76 | 82 |
| pH | 8.0 | 7.8 | 82 | 76 |
| pH | 8.5 | 8.2 | 72 | 94 |
| pH | 9.0 | 8.8 | 68 | 77 |
26
d Analytical specificity
d.1 Exogenous and Endogenous Interference
Select urine sample and mix it well to prepare negative samples for each dry chemistry item. Prepare the first positive-grade sample (excluding pH and specific gravity) by adding the substance to be tested, Dissolve the interfering substance with an appropriate solvent according to the chemical properties of the interfering substance. The concentration of the stock solution shall be appropriate to reduce dilution of the basic sample matrix. The dilution ratio of the sample matrix shall not exceed 5%, Absorb an appropriate volume of interfering substance stock solution according to a certain proportion and add it into the volumetric flask, and then fix to the scale with the basic sample to prepare a sample containing a single interfering substance. The concentration of interfering substances in different samples is shown in Table 22.
| Interfering substance | Concentration | Interfering substance | Concentration | Interfering substance | Concentration |
|---|---|---|---|---|---|
| Exogenous interfering substances | Endogenous interfering substances | ||||
| Acetaminophen | 300 mg/dL | Quaternary Ammonium | 200mg/dL | Hydroxybutyrate dehydrogenase | 450 mg/dL |
| Amoxicillin | 1333 mg/dL | Lithium acetoacetate | 250 mg/dL | Ammonium chloride | 2500 mg/dL |
| Ascorbic acid | 400 mg/dL | Peroxide | 10% | Bilirubin | 170 mg/dL |
| Biotin | 100 mg/dL | Peroxidase | 20mg/dL | Calcium chloride | 300 mg/dL |
| Cefoxitin | 1200 mg/dL | Sodium thiosulfate | 20mg/dL | Creatinine | 1500 mg/dL |
| Furosemide | 200 mg/dL | Potassium chloride | 1500 mg/dL | Glucose | 10000mg/dL |
| Gabapentin | 1200 mg/dL | Sodium Bicarbonate | 1500 mg/dL | HGB | 83 mg/dL |
| Gentamicin sulphate | 40 mg/dL | Citric acid | 150 mg/dL | Protein | 500 mg/dL |
| Ibuprofen | 250 mg/dL | Creatine | 10 mg/dL | Nitrite | 11 mg/dL |
| Levodopa | 125 mg/dL | Fructose | 100mg/dL | Urea | 20000 mg/dL |
| Lisinopril | 27 mg/dL | Galactose | 80 mg/dL | Urea acid | 155mg/dL |
| Metformin | 850 mg/dL | Oxalic acid | 70mg/dL | Urobilinogen | 300mg/dL |
| Methyldopa | 200 mg/dL | Vitamin B | 10mg/dL | Human immunoglobulin IgG | 500mg/dL |
| Methylamine + methylene blue | 400 + 66.5 mg/dL | Sodium acetate | 2.25mg/dL | Leukocyte | 2500leu/uL |
| Acetylcysteine | 20 mg/dL | Sodium chloride | 5500mg/dL | Cysteine | 20mg/dL |
| Ofloxacin | 90 mg/dL | Sodium nitrate | 10mg/dL | Blood | 0.05% |
| Phenazopyridine | 30 mg/dL | Sodium phosphate | 500mg/dL | Glycine | 450 mg/dL |
| Salicylic acid | 600 mg/dL | Theophylline | 100 mg/dL | Lactose | 10mg/dL |
| Tetracycline | 50 mg/dL | Leukocyte | 2500leu/uL |
| Table 22 Interfering substance and concentration | ||||||
|---|---|---|---|---|---|---|
| -------------------------------------------------- | -- | -- | -- | -- | -- | -- |
Add the solvent of the same volume as the experimental sample (the solvent used to prepare the stock solution) into the second volumetric flask and fix to the scale with the basic sample (experimental sample and control sample) shall be tested for five times on two UC-1800 machines, two batch numbers of 11FA and 12FA reagent strips. Results are summarized in the tables below.
1. The substances show no interference for all analytes
The following substances, i.e. Cefaxitin, Phenazopyridine, Salicylic acid, Tetracycline, Hydroxybutyrate delydrogenase, Protein, Lactose, Leukocyte, Potassium chloride, Citric acid, Creatine, Oxalic acid, Vitamin B, Sodium acetate, Sodium chloride, Sodium nitrate, Theophylline show no interference for all analytes at tested are summarized in Table 23.
| Interfering substance | Maximum concentration
without interference |
|-----------------------|-----------------------------------------------|
| Cefoxitin | 1200 mg/dL |
| Ofloxacin | 90 mg/dL |
Table 23 The substances that do not cause interference
27
| Interfering substance | Maximum concentration
without interference |
|-------------------------------|-----------------------------------------------|
| Phenazopyridine | 30 mg/dL |
| Salicylic acid | 600 mg/dL |
| Tetracycline | 50 mg/dL |
| Hydroxybutyrate dehydrogenase | 450 mg/dL |
| Protein | 500 mg/dL |
| Lactose | 10mg/dL |
| Leukocyte | 2500leu/uL |
| Potassium chloride | 1500 mg/dL |
| Citric acid | 150 mg/dL |
| Creatine | 10mg/dL |
| Fructose | 100mg/dL |
| Galactose | 80 mg/dL |
| Oxalic acid | 70mg/dL |
| Vitamin B | 10mg/dL |
| Sodium acetate | 2.25mg/dL |
| Sodium chloride | 5500mg/dL |
| Sodium nitrate | 10mg/dL |
| Theophylline | 100 mg/dL |
28
2.The substances that cause interference
For those substances that on initial screening with certain analytes, dose response testing was conducted to establish the concentration limitible) which no significant interference is expected. The results are given in the tables below
Table 24 The substances that cause interference
| Analyte | Interfering substances | Maximum concentration
without interference (mg/dL) | Interference
concentration (mg/dL) | Specific interference effect | Strip | | | | | |
|--------------|------------------------------|-------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------|-------|--|------------------------------------------|--|--|
| Leukocyte | Urobilinogen | 25 | 50 | From - to +- (False Positive) | | | | | | |
| | Amoxicillin | 700 | 1050 | From +- to 1 (elevated positive result) | | | | | | |
| | Ibuprofen | 125 | 187.5 | From +- to 2 (elevated positive result) | | | | | | |
| | Methylamine + methylene blue | 200+35 | 300+52.5 | From - to 1 (False Positive) | URIT 11/12 FA
Urine Reagent
Strips | | | | | |
| | Bilirubin | 60 | 80 | From +- to - (False Negative) | | | | | | |
| | Glucose | 1500 | 1666.7 | From +- to - (False Negative) | | | | | | |
| | Sodium Bicarbonate | 375 | 750 | From +- to - (False Negative) | | | | | | |
| | Glycine | 225 | 337.5 | From +- to - (False Negative) | | | | | | |
| | Sodium phosphate | 250 | 375 | From +- to - (False Negative) | | | | | | |
| Ketones | Methyldopa | 50 | 100 | From +- to - (False Negative) | | | | | | |
| | Methylamine + methylene blue | 100+17.5 | 150 | From - to +- (False Positive) | | | | | | |
| | Acetylcysteine | 3.3 | 200+35 | From +- to 1 (elevated positive result) | URIT 11/12 FA
Urine Reagent
Strips | | | | | |
| | Ammonium chloride | 1250 | 5 | From +- to - (False Negative) | | | | | | |
| | Bilirubin | 60 | 5 | From - to +- (False Positive) | | | | | | |
| | Creatinine | 1125 | 1875 | From +- to - (False Negative) | | | | | | |
| | Gabapentin | 15 | 80 | From +- to - (False Negative) | | | | | | |
| Urobilinogen | Methylamine + methylene blue | 66.7+11.7 | 1500 | From - to +- (False Positive) | | | | | | |
| | Bilirubin | 40 | 22.5 | From 1 to Normal (False Negative) | | | | | | |
| | Nitrite | 0.8 | 200+35 | From Normal to 1 (False Positive) | URIT 11/12 FA
Urine Reagent
Strips | | | | | |
| Bilirubin | Urobilinogen | 12.5 | 100+17.5 | From 1 to 2 (elevated positive result) | | | | | | |
| | Ascorbic acid | 150 | 60 | From 1+ to 2+ (elevated positive result) | | | | | | |
| | Methylamine + methylene blue | 200+35 | 1.7 | From 1+ to Normal (False Negative) | | | | | | |
| | Nitrite | 5 | 25 | From - to 1 (False Positive) | URIT 11/12 FA
Urine Reagent
Strips | | | | | |
| Glucose | Lithium acetoacetate | 80 | 50 | From - to 2 (False Positive) | | | | | | |
| | Peroxide | 5% | 25 | From 1 to 2 (elevated positive result) | | | | | | |
| | Ascorbic acid | 50 | 200 | From 1 to - (False Negative) | | | | | | |
| | Levodopa | 10.8 | 300+52.5 | From 1 to - (False Negative) | | | | | | |
| | Methylamine + methylene blue | 100+17.5 | 10 | From 1 to - (False Negative) | | | | | | |
| | Bilirubin | 40 | 125 | From +- to - (False Negative) | | | | | | |
| Protein | Urea | 10050 | 7.50% | From - to +- (False Positive) | URIT 11/12 FA
Urine Reagent
Strips | | | | | |
| | Quaternary Ammonium | 50 | 7.50% | From +- to 1 (elevated positive result) | | | | | | |
| | Sodium Bicarbonate | 750 | 100 | From +- to - (False Negative) | | | | | | |
| | Amoxicillin | 700 | 21.7 | From +- to - (False Negative) | | | | | | |
| | Gabapentin | 7.5 | 200+35 | From +- to - (False Negative) | | | | | | |
| | Ibuprofen | 62.5 | 60 | From +- to - (False Negative) | | | | | | |
| | Methylamine + methylene blue | 66.7+11.7 | 15025 | From +- to - (False Negative) | | | | | | |
| | Ammonium chloride | 625 | 100 | From - to +- (False Positive) | | | | | | |
| | Bilirubin | 40 | 150 | From - to 1 (False Positive) | | | | | | |
| | Calcium chloride | 150 | 100 | From +- to 1 (elevated positive result) | | | | | | |
| | Creatinine | 375 | 150 | From +- to 2 (elevated positive result) | | | | | | |
| | HGB | 1250 | 1125 | From +- to 1 (elevated positive result) | | | | | | |
| | Urea | 10050 | 1050 | From +- to - (False Negative) | | | | | | |
| | | | 15 | From +- to 1+ (elevated positive result) | | | | | | |
| | | | 125 | From +- to - (False Negative) | | | | | | |
| | | | 200+35 | From - to +- (False Positive) | | | | | | |
| | | | 100+17.5 | From +- to 1+ (elevated positive result) | URIT 11/12 FA
Urine Reagent
Strips | | | | | |
| | | | 1250 | From +- to - (False Negative) | | | | | | |
| | | | 60 | From - to +- (False Positive) | | | | | | |
| | | | 225 | From +- to - (False Negative) | | | | | | |
| | | | 1500 | From - to +-/1+ (False Positive and elevated
positive result) | | | | | | |
| | | | 750 | From +- to 1+ (elevated positive result) | | | | | | |
| | | | 3750 | From - to +-/1+ (False Positive and elevated
positive result) | | | | | | |
| | | | 2500 | From +- to 1+ (elevated positive result) | | | | | | |
| | | | | | | 15025 | | From +- to 1+ (elevated positive result) | | |
| | HGB | 1250 | 3750
2500 | From - to +/-/1+ (False Positive and elevated positive result)
From +- to 1+ ( elevated positive result) | | | | | | |
| | Urea | 10050 | 15025 | From +- to 1+ ( elevated positive result) | | | | | | |
29
| Analyte | Interfering substances | Maximum concentration
without interference (mg/dL) | Interference
concentration (mg/dL) | Specific interference effect | Strip | |
|------------------|------------------------------|-------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|
| Blood | Peroxidase | 5 | 10 | From - to +- (False Positive) | | |
| | Sodium Bicarbonate | 375 | 750 | From +- to 1 (elevated positive result) | | |
| | Glycine | 112.5 | 225 | From +- to - (False Negative) | | |
| | Ascorbic acid | 50 | 100 | From +- to 1 ( elevated positive result) | | |
| | Biotin | 2500 | 3750 | From +- to - (False Negative) | | |
| | Furosemide | 50 | 100 | From - to +- (False Positive) | URIT 11/12 FA
Urine Reagent
Strips | |
| | Ibuprofen | 187.5 | 250 | From +- to - (False Negative) | | |
| | Levodopa | 10.8 | 21.7 | From +- to - (False Negative) | | |
| | Methyldopa | 16.7 | 33.3 | From - to +- (False Positive) | | |
| | Methyldopa | 16.7 | 150 | From +- to 1+ ( elevated positive result) | | |
| | Methylamine + methylene blue | 66.7+11.7 | 100+17.5 | From - to +- (False Positive)
From +- to 1+ ( elevated positive result) | | |
| Specific Gravity | Salicylic acid | 300 | 450
600 | From 1.010 to 1.020 (Result rise)
From 1.010 to 1.030 (Result rise) | URIT 11/12 FA
Urine Reagent
Strips | |
| | Uric acid | 116.25 | 155 | From 1.015 to 1.025 (Result rise) | | |
| | Sodium bicarbonate | 1125 | 1500 | From 1.020 to 1.005 (Result reduction) | | |
| | Urobilinogen | 12.5 | 25 | From - to + (False Positive) | | |
| Nitrite | Sodium Bicarbonate | 750 | 1125 | From + to - (False Negative) | | |
| | Ascorbic acid | 50 | 100 | From + to - (False Negative) | URIT 11/12 FA
Urine Reagent
Strips | |
| | Methylamine + methylene blue | 200+35 | 300+52.5 | From - to + (False Positive) | | |
| | Bilirubin | 60 | 80 | From + to - (False Negative) | | |
| | Creatinine | 750 | 1125 | From + to - (False Negative) | | |
| Ascorbic acid | Sodium thiosulfate | 10 | 15 | From - to +- (False Positive)
From +- to 1 ( elevated positive result) | | |
| | Cysteine | 10 | 15 | From - to +- (False Positive)
From +- to 1 ( elevated positive result) | URIT 11 FA
Urine Reagent
Strips | |
| | Sodium phosphate | 250 | 375 | From +- to 1 ( elevated positive result) | | |
| | Levodopa | 5.4 | 10.8 | From +- to 1+ (elevated positive result) | | |
| | Acetylcysteine | 10 | 15 | From +- to 1+ (elevated positive result) | | |
| | Ammonium chloride | 1875 | 2500 | From +- to 1+ (elevated positive result) | | |
| | Quaternary Ammonium | 50 | 100 | From 10mg/L to 30mg/L (False Positive)
From 30mg/L to 80mg/L ( elevated positive result) | | |
| Microalbumin | Blood | 0.0375% | 0.05% | From 10mg/L to 30mg/L (False Positive)
From 30mg/L to 80mg/L ( elevated positive result) | | |
| | Human immunoglobulin lgG | 41.67 | 83.33 | From 10mg/L to 30mg/L (False Positive)
From 10mg/L to 80mg/L (False Positive)
From 30mg/L to 80mg/L ( elevated positive result)
From 30mg/Lto 150mg/L( elevated positive result) | | |
| | Ascorbic acid | 200 | 300 | From 30 mg/L to 10 mg/L (False Negative) | URIT 12 FA
Urine Reagent
Strips | |
| | Gabapentin | 7.5 | 30 | From 10 mg/L to 30 mg/L (False Positive)
From 30 mg/L to 80 mg/L ( elevated positive result) | | |
| | Methylamine + methylene blue | 66.7+11.7 | 100 + 17.5 | From 10mg/L to 30mg/L (False Positive)
From 30mg/L to 80mg/L ( elevated positive result) | | |
| | Ammonium chloride | 625 | 1250 | From30mg/L to 10mg/L (False Negative)
From10mg/L to 30mg/L (False Positive) | | |
| | Creatinine | 600 | 1500 | From30mg/L to 80mg/L ( elevated positive result) | | |
| | HGB | 83 | 750
830 | From10mg/L to 30mg/L (False Positive)
From30mg/L to 80mg/L ( elevated positive result) | | |
| | Acetaminophen | 225 | 208
300 | From 50 mg/dL to 100 mg/dL ( elevated positive result | | |
| | Biotin | 830 | 1250 | From 50 mg/dL to 100 mg/dL(elevated positive result) | | |
| | | | | | | |
| | Creatinine | Furosemide | 100 | 150 | From 50 mg/dL to 100 mg/dL (elevated positive result) | URIT 12 FA |
| | | Gabapentin | 15 | 22.5 | From 50 mg/dL to 100 mg/dL (elevated positive result) | Urine Reagent |
| | | Gentamicin sulphate | 20 | 30 | From 50 mg/dL to 10 mg/dL (False Negative) | Strips |
| | | Acetylcysteine | 3.3 | 200 | From 10 mg/dL to 50 mg/dL (False Positive) | |
| | | | | | 5 | From 50 mg/dL to 100 mg/dL (elevated positive result) |
| | | Ammonium chloride | 100 | 104.2 | From 50 mg/dL to 10 mg/dL (False Negative) | |
30
d.2 Effect of urine pH
Collect mixed negative urine samples and divise their pH values with 1M hydrochloric acid aqueous solution and 1M sodium hydroxide aquous solution to prepare samples with pH value of 4.5, 5.5, 6.5, 7.5, and 8.5, respectively. Each sample shall be tested for 5 times on 2 UC-1800 machines, two batch numbers of 11FA and 12FA test strips, respectively For all test strip and specific gravity, For leukorytes, unine pH values lover than 5.5 may yield a false negative result. For specific result. For spec No significant interference was observed for the urine pH ranges from 5.5 to 7.5, Urine pH values lower than 5.5 may yield a false increased of Specific Gravity, and urine pH values higher than 7.5 may yield decreased of specific gravity. The results were summarized as Table 25 shows.
| Table 25 Summary of effect of urine pH | ||
|---|---|---|
| URIT 11/12 FA Urine Reagent Strips | ||
| Item | No interference pH | Interference condition |
| Leukocytes | pH>5.5 | pH=4.5, From +- to - (False Negative) |
| Specific Gravity | 5.5-7.5 | pH=4.5, From 1.015 to 1.025 (False Positive) |
| pH=4.5, From 1.020 to 1.030 (False Positive) | ||
| pH≥8.5, From 1.015 to 1.005 (False Negative) | ||
| pH≥8.5, From 1.020 to 1.010 (False Negative) |
d.3 Effect of urine color
Collect mixed negative une samples and divide them into 3 parts tellow, ligin, lemon yellow, Naphthol green, Bright blue and Crystal violet to prepare the samples into the red, orage, brown, yellow purple samples ball be tested for 5 times on two UC-1800 machines of 11FA and 1274 test stips, respectively. All the results dentified that all color showed no interference on each and and a colle 26 to Table 31 shows.
| URIT 11/12FA Urine Reagent Strips | |||||||
|---|---|---|---|---|---|---|---|
| Analyte | Concentration | Red | Orange | Brown | |||
| HGB | |||||||
| Concentration | Result | Sunset yellow | |||||
| Concentration | Result | Lignin | |||||
| Concentration | Result | ||||||
| Leukocyte | - (0 leu/mcL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| +/- (15 leu/mcL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| Ketones | - (0 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| +/- (5 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| Urobilinogen | Normal (Normal) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| 1 (2.0 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| Bilirubin | - (0 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| 1 (0.5 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| Glucose | - (0 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| +/- (50 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| Protein | - (0 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| +/- (15 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| Blood | - (0 ery/mcL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| +/- (10 ery/mcL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| Specific Gravity | 1.015 (1.015) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| 1.020 (1.020) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| pH | 6.5 (6.5) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| 7.5 (7.5) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| Nitrite | - (0 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| + (0.5 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
Table 26 Summary of effect of urine color - Red, Orange, Brown (11/12FA)
Table 27 Summary of effect of urine color – Yellow, Green, Blue, Purple (11/12FA)
| URIT 11/12FA Urine Reagent Strips | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Yellow | Green | Blue | Purple | ||||||
| Analyte | Concentration | Lemon yellow | |||||||
| Concentration | Result | Naphthol green | |||||||
| Concentration | Result | Bright blue | |||||||
| Concentration | Result | Crystal violet | |||||||
| Concentration | Result | ||||||||
| - (0 leu/mcL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Leukocyte | +/- (15 leu/mcL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| - (0 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Ketones | +/- (5 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| Normal (Normal) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Urobilinogen | 1 (2.0 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| - (0 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Bilirubin | 1 (0.5 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| - (0 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Glucose | +/- (50 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| - (0 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Protein | +/- (15 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| - (0 ery/mcL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Blood | +/- (10 ery/mcL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| 1.015 (1.015) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Specific Gravity | 1.02 (1.02) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| pH | 6.5 (6.5) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| 7.5 (7.5) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| - (0 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Nitrite | + (0.5 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
31
| Red | Orange | Brown | ||||||
|---|---|---|---|---|---|---|---|---|
| Analyte | Concentration | HGB | ||||||
| Concentration | Result | Sunset yellow | ||||||
| Concentration | Result | Lignin | ||||||
| Concentration | Result | |||||||
| Ascorbic acid | - (0 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference | |
| Ascorbic acid | +/- (10 mg/dL) | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
Table 29 Summary of effect of urine color – Yellow, Green, Blue, Purple (11FA)
| Analyte | Concentration | Yellow | Green | Blue | Purple | ||||
|---|---|---|---|---|---|---|---|---|---|
| Lemon yellow | |||||||||
| Concentration | Result | Naphthol green | |||||||
| Concentration | Result | Bright blue | |||||||
| Concentration | Result | Crystal violet | |||||||
| Concentration | Result | ||||||||
| Ascorbic acid | - (0 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| +/- (10 mg/dL) | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
Table 30 Summary of effect of urine color - Red, Orange, Brown (12FA)
| Analyte | Concentration | Red | Orange | Brown | |||
|---|---|---|---|---|---|---|---|
| HGB Concentration | Result | Sunset yellow Concentration | Result | Lignin Concentration | Result | ||
| Microalbumin | 0 mg/L | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| Microalbumin | 30 mg/L | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| Creatinine | 0 mg/dL | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
| Creatinine | 50 mg/dL | 0,750,300 mg/L | No interference | 0,312.5,150 mg/L | No interference | 0;1;0.4 mg/L | No interference |
Table 31 Summary of effect of urine color – Yellow, Green, Blue, Purple (12FA)
| Concentration | Yellow | Green | Blue | Purple | |||||
|---|---|---|---|---|---|---|---|---|---|
| Analyte | Lemon yellow | Result | Naphthol green | Result | Bright blue | Result | Crystal violet | Result | |
| Concentration | Concentration | Concentration | Concentration | ||||||
| Microalbumin | 0 mg/L | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| 30 mg/L | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference | |
| Creatinine | 0 mg/dL | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
| 50 mg/dL | 0;20;3 mg/L | No interference | 0;40;20 mg/L | No interference | 0;10;1 mg/L | No interference | 0;10;3 mg/L | No interference |
d.1 Effect of urine Specific Gravity
Collect mixed negative urine samples and divide to adjust their specific gravity to prepare the samples with specific gravity of 1.005, 1.100, 1.015, 1.130, 1.135, 1.130, 1.045, and 1.150 respective); Each sample shall be tested for 5 times on two UC-800 machines, two batch numbers of 11FA and 12H test strips.
Table 32 Summary of Effect of urine Specific Gravity
| URIT 11/12 FA Urine Reagent Strips | ||
|---|---|---|
| Item | No interference SG | Interference situation |
| Leukocytes | SG |