(163 days)
No
The device description details a reflectance photometer system that calculates results based on reflection rates. There is no mention of AI, ML, or complex algorithms beyond standard signal processing for color intensity measurement. The performance studies focus on analytical performance and method comparison, not on the validation of AI/ML models.
No
Explanation: The device is intended for in vitro diagnostic use to aid in the diagnosis of various conditions by analyzing urine chemistry, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for point-of-care, in vitro diagnostic use only" and that "These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function."
No
The device description clearly states it is an "automated, bench top instrument" and a "portable easy to use instrument" that "reads Teco Diagnostics' Urine Reagent (URS-10) Strips". It describes hardware components like a display, internal printer, serial computer interface, electrical outlet, and a system for irradiating the test area with light and detecting reflectance using a photodiode. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Uritek TC-201 Urine Chemistry Test System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is "intended for point-of-care, in vitro diagnostic use only". It also describes its purpose as the "semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine" to "aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function." This clearly aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details how the device analyzes urine samples using reagent strips, which is a common method for in vitro diagnostic testing.
- Performance Studies: The document describes various performance studies (Precision, Sensitivity, Linearity, Stability, Interference, Comparison) which are typical evaluations required for IVD devices to demonstrate their analytical performance and clinical utility.
- Predicate Device: The mention of a predicate device (Siemens Clinitek Status Plus Analyzer) with a K number (K091216) indicates that this device is being compared to a previously cleared IVD device, further supporting its classification as an IVD.
- Reference Device: The mention of the Teco Diagnostics Urine Reagent (URS-10) Strips with a K number (K970250) as a reference device also points to the system's use with a cleared IVD component.
In summary, the explicit statement of "in vitro diagnostic use," the nature of the tests performed on urine samples, and the context of regulatory submissions (indicated by the mention of predicate and reference devices with K numbers) all confirm that the Uritek TC-201 Urine Chemistry Test System is an IVD device.
N/A
Intended Use / Indications for Use
The Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
Product codes
JIL, JIO, KQO, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB
Device Description
The Uritek TC-201 Urine Analyzer (TC-201) is a portable easy to use instrument which reads Teco Diagnostics' Urine Reagent (URS-10) Strips for testing in the clinical laboratory. The analyzer can determine the intensity of different colors on the reagent strip test area. It does this by irradiating the test area with light and detecting the reflectance of different wavelengths using photodiode. Results are calculated by a reflection rate which is a percentage of the total reflectance of the testing wavelength and are printed automatically.
The Uritek TC-201 Urine Analyzer reports semi-quantitative assays for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. The analyzer features a display, internal printer, a serial computer interface and an electrical outlet. Communication between the operator and the analyzer is made through the display using the user interface touch screen on the front surface of the instrument. Reagent strip results are automatically displayed on the screen in one minute. A printed hardcopy can also be created either from the results screen or recalled from memory.
The Urine Reagent Strips (URS-10) for Urinalysis are firm plastic strips to which ten different reagent pads are affixed. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. The Teco Urine Reagent (URS-10) Strips provide tests for the semi-quantitative determination of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point-of-care, 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)
1. Software: Software development, verification, and validation were performed according to FDA guidance.
2. Electrical Safety and Electromagnetic Compatibility: The device complies with IEC 61010-1, IEC 61010-2-101, IEC 61326-1, and IEC 61326-2-6.
3. Analytical Performance:
- A. Precision Study:
- i) In-house Precision Study: Evaluated within-run precision and run-to-run precision using commercially available urine control solutions at Level I (High analyte concentration), Level II (Low analyte concentration), and Level III (Negative).
- Within-Run Precision:
- N=180 strips per control level (20 strips x 3 strip lots x 1 day x 3 operators/analyzers).
- All analytes read 100% within the expected results +/- one color block.
- Run-to-Run Precision:
- N=120 strips per control level (3 strips x 2 run x 10 days x 2 operators/analyzers/strip lots).
- All analytes read 100% within the expected results +/- one color block.
- ii) Point-of-Care Precision Study: Evaluated precision at 3 POC sites using commercially available urine control solutions at Level I, Level II, and Level III.
- N=40 testing per sample (duplicates per run, two runs per day for 10 days).
- All analytes read 100% within the expected results +/- one color block.
- B. Linearity/Assay Reportable Range:
- Evaluated the reportable range for each analyte on the URS-10 strips. Sample measurement performed in replicates of 8 by 3 operators on each of 3 individual strip lots for a total of 24 measurements per sample.
- Measured range for each color block presented.
- C. Traceability and Stability:
- Traceability and Expected Value: Assessed using three levels of commercial urine controls (Negative, Low, High).
- Stability: Three types of stability studies performed:
- (1) Open bottle study: Monitored URS-10 strip integrity after opening for 13 weeks. Tested periodically using commercial urine controls levels I, II, and III. Acceptance criterion: read within expected ranges for >= 90 days.
- (2) Accelerated stability study: Assessed shelf-life by testing URS-10 strips once per week periodically for 13 weeks using commercial urine controls levels I, II, and III. Acceptance criterion: read within expected ranges for > 90 days to confirm 2-year shelf life.
- (3) Real-time shelf-life study: Ongoing study testing sealed bottles of URS-10 strips every 6 months until 18 months, then every 3 months until 27 months. Acceptance criterion: read within expected ranges through expiration date.
- Results Summary: All levels passed for open bottle and accelerated stability. Real time shelf life is an ongoing study.
- D. Detection Limit:
- Determined cutoff point concentration for each analyte. Samples prepared at minimum of 4 levels across the measuring range. Analyzed in replicates of 8 by 3 operators on 3 individual strip lots (24 data points per level).
- Cutoff defined as lowest concentration at which >55% of test results are positive.
- Cut-off values and percentage sensitivity for each color block are summarized.
- E. Analytical Specificity:
- Endogenous and Exogenous Interference Study: Evaluated interference of potential substances by adding at least 2 levels to negative, low positive, and high positive urine pools. Tested with 3 replicates. Interference defined as +/- 1 color block change.
- pH Interference Study: Evaluated effect of sample pH (5.0 to 9.0). pH > 8.5 affected protein test (false high).
- Specific Gravity Interference Study: Evaluated effect of sample specific gravity (1.000 to 1.040). SG > 1.030 affected pH and protein tests (false low).
- F. Flex Study:
- Temperature and Humidity Study: Evaluated effect of 80% humidity and >=30C. Stable at 92% humidity for over 24h at 30C; 5 replicates passed.
4. Comparison Study:
- A. Method Comparison with Predicate Device:
- Study Type: Multi-site method comparison study.
- Sample Size: 509 urine specimens (392 unaltered patient samples + 10% contrived samples, plus 91 additional clinical samples, plus 26 pre-screened pH >= 8.0 samples).
- Data Source: 3 Point-of-Care (POC) Sites (Clinica Medica Del Sagrado Corazon, Clinica Medica San Miquel, Artritis & Osteoporosis Center).
- Key Results & Agreement:
- Glucose: 98.43% overall exact match, 100.0% overall agreement +/-1 color block.
- Bilirubin: 98.82% overall exact match, 100.0% overall agreement +/-1 color block.
- Ketone: 98.43% overall exact match, 100.0% overall agreement +/-1 color block.
- Specific Gravity: 82.71% overall exact match, 100.0% overall agreement +/-1 color block. (Acceptance Criteria for SG is +/- 0.005)
- Blood: 98.04% overall exact match, 100.0% overall agreement +/-1 color block.
- Protein: 97.25% overall exact match, 100.0% overall agreement +/-1 color block.
- Urobilinogen: 99.61% overall exact match, 100.0% overall agreement +/-1 color block.
- pH: 90.57% overall exact match, 99.61% overall agreement +/-1 color block.
- Nitrite: 99.41% overall exact match. (No +/-1 color block agreement applies given binary result)
- Leukocyte: 97.84% overall exact match, 100% overall agreement +/-1 color block.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision Study (In-house Within-Run):
- Glucose: 98.33% Exact Match, 100% +/- Color Block Agreement
- Bilirubin: 98.33% Exact Match, 100% +/- Color Block Agreement
- Ketone: 99.44% Exact Match, 100% +/- Color Block Agreement
- Specific Gravity: 97.78% Exact Match, 100% +/- Color Block Agreement
- Blood: 100% Exact Match, 100% +/- Color Block Agreement
- Nitrite: 100% Exact Match, 100% +/- Color Block Agreement
- Protein: 100% Exact Match, 100% +/- Color Block Agreement
- Urobilinogen: 100% Exact Match, 100% +/- Color Block Agreement
- Leukocyte: 100% Exact Match, 100% +/- Color Block Agreement
- pH: 96.11% Exact Match, 100% +/- Color Block Agreement
Precision Study (In-house Run-to-Run):
- Glucose: 100% Exact Match, 100% +/- Color Block Agreement
- Bilirubin: 99.17% Exact Match, 100% +/- Color Block Agreement
- Ketone: 100% Exact Match, 100% +/- Color Block Agreement
- Specific Gravity: 98.33% Exact Match, 100% +/- Color Block Agreement
- Blood: 100% Exact Match, 100% +/- Color Block Agreement
- Nitrite: 100% Exact Match, 100% +/- Color Block Agreement
- Protein: 100% Exact Match, 100% +/- Color Block Agreement
- Urobilinogen: 100% Exact Match, 100% +/- Color Block Agreement
- Leukocyte: 100% Exact Match, 100% +/- Color Block Agreement
- pH: 97.50% Exact Match, 100% +/- Color Block Agreement
Precision Study (Point-of-Care Sites Combined):
- Glucose: 100% Exact Match, 100% Match within +/- 1 color block
- Bilirubin: 100% (Level I), 99.17% (Level II), 100% (Level III) Exact Match; 100% Match within +/- 1 color block for all levels.
- Ketone: 100% Exact Match, 100% Match within +/- 1 color block
- Specific Gravity: 99.17% (Level I), 100% (Level II), 100% (Level III) Exact Match; 100% Match within +/- 1 color block for all levels.
- Blood: 100% (Level I), 99.17% (Level II), 100% (Level III) Exact Match; 100% Match within +/- 1 color block for all levels.
- Nitrite: 100% Exact Match, 100% Match within +/- 1 color block
- Protein: 100% Exact Match, 100% Match within +/- 1 color block
- Urobilinogen: 99.17% (Level I), 100% (Level II), 100% (Level III) Exact Match; 100% Match within +/- 1 color block for all levels.
- Leukocyte: 100% (Level I), 99.17% (Level II), 100% (Level III) Exact Match; 100% Match within +/- 1 color block for all levels.
- pH: 98.33% (Level I), 98.33% (Level II), 100% (Level III) Exact Match; 100% Match within +/- 1 color block for all levels.
Detection Limit (Percentage Positive Results at Cut-off):
- Glucose: 67% (100 mg/dL block) to 83% (250 mg/dL and 500 mg/dL blocks)
- Bilirubin: 59% (Small) to 87.5% (Moderate)
- Ketone: 71% (Trace, 15 mg/dL blocks) to 91% (40 mg/dL block)
- Blood: 67% (Moderate) to 75% (Small)
- Protein: 75% (30 mg/dL block) to 91% (Trace)
- Nitrite: 58% (Positive)
- Leukocyte: 58% (Trace, Moderate) to 67% (Small, Large)
- Urobilinogen: 55% (4.0 mg/dL block) to 100% (0.2 mg/dL block)
- pH: 96% for all listed pH blocks except 6.0 (100%)
- SG: 92% for all listed SG blocks
Method Comparison with Predicate Device (Overall Exact Match and +/-1 Color Block Agreement):
- Glucose: 98.43% Exact Match, 100.0% +/-1 Color Block Agreement
- Bilirubin: 98.82% Exact Match, 100.0% +/-1 Color Block Agreement
- Ketone: 98.43% Exact Match, 100.0% +/-1 Color Block Agreement
- Specific Gravity: 82.71% Exact Match, 100.0% +/-1 Color Block Agreement
- Blood: 98.04% Exact Match, 100.0% +/-1 Color Block Agreement
- Protein: 97.25% Exact Match, 100.0% +/-1 Color Block Agreement
- Urobilinogen: 99.61% Exact Match, 100.0% +/-1 Color Block Agreement
- pH: 90.57% Exact Match, 99.61% +/-1 Color Block Agreement
- Nitrite: 99.41% Exact Match (N/A for +/-1 Color Block Agreement)
- Leukocyte: 97.84% Exact Match, 100.0% +/-1 Color Block Agreement
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a triple-lined design representing the bodies.
July 22, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
TECO DIAGNOSTICS, INC. AQUIL MERCHANT RESEARCH SCIENTIST 1268 N. LAKEVIEW AVE. ANAHEIM CA 92807
Re: K160372
Trade/Device Name: Uritek TC-201 Urine Chemistry Test System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: II Product Code: JIL, JIO, KQO, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB Dated: June 1, 2016 Received: June 2, 2016
Dear Mr. Merchant:
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 (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. 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.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For :
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K160372 |
| Device Name | Uritek TC-201 Urine Chemistry Test System |
| Indications for Use (Describe) | The Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function. |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
| FORM FDA 3881 (8/14) | Page 1 of 1 PSC Publishing Services (301) 443-6740 EF |
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Image /page/3/Picture/0 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black.
I. SUBMITTER
Applicant Information:
Teco Diagnostics, Inc. 1268 North Lakeview Avenue Anaheim, CA 92807 Phone: 714-463-1111 Fax: 714-463-1169
Contact Person: Aquil Merchant, M.S. Research Scientist Email: aquil@tecodiagnostics.com | Web: http://www.tecodiagnostics.com
Date Prepared: July 20th, 2016
II. DEVICE
Device Name: Uritek TC-201 Urine Chemistry Test System
Common Name:
Automated Urinalysis System, Urinary Test System The system consists of the Uritek TC-201 Urine Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips (K970250).
Regulatory Information:
Panel:
Clinical Chemistry
| Regulation section | Code | Test | Classification |
|---|---|---|---|
| 21 CFR § 862.1340 | JIL | Urinary Glucose (nonquantitative) Test System | II |
| 21 CFR § 864.6550 | JIO | Occult Blood Test | II |
| 21 CFR § 862.2900 | KQO | Automated Urinalysis System | I |
| 21 CFR § 864.7675 | LJX | Leukocyte Peroxidase Test | I |
| 21 CFR § 862.2800 | JRE | Refractometer for clinical use | I |
| 21 CFR § 862.1550 | CEN | Urinary pH (nonquantitative) Test System | I |
| 21 CFR § 862.1510 | JMT | Nitrite (nonquantitative) Test System | I |
| 21 CFR § 862.1645 | JIR | Urinary Protein or Albumin (nonquantitative) Test System | I |
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Image /page/4/Picture/0 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black.
| 21 CFR § 862.1435 | JIN | Ketones (nonquantitative) Test System | I |
|---|---|---|---|
| 21 CFR § 862.1785 | CDM | Urinary Urobilinogen (nonquantitative) Test System | I |
| 21 CFR § 862.1115 | JJB | Urinary Bilirubin and its conjugates (nonquantitative) Test System | I |
III. PREDICATE DEVICE
Siemens (formally Bayer) Clinitek Status Plus Analyzer SIEMENS HEALTHCARE DIAGNOSTICS 2 Edgewater Dr. Norwood, MA 02062 510(k) Number: K091216
IV. DEVICE DESCRIPTION
The Uritek TC-201 Urine Analyzer (TC-201) is a portable easy to use instrument which reads Teco Diagnostics' Urine Reagent (URS-10) Strips for testing in the clinical laboratory. The analyzer can determine the intensity of different colors on the reagent strip test area. It does this by irradiating the test area with light and detecting the reflectance of different wavelengths using photodiode. Results are calculated by a reflection rate which is a percentage of the total reflectance of the testing wavelength and are printed automatically.
The Uritek TC-201 Urine Analyzer reports semi-quantitative assays for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. The analyzer features a display, internal printer, a serial computer interface and an electrical outlet. Communication between the operator and the analyzer is made through the display using the user interface touch screen on the front surface of the instrument. Reagent strip results are automatically displayed on the screen in one minute. A printed hardcopy can also be created either from the results screen or recalled from memory.
The Urine Reagent Strips (URS-10) for Urinalysis are firm plastic strips to which ten different reagent pads are affixed. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. The Teco Urine Reagent (URS-10) Strips provide tests for the semi-quantitative determination of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine.
5
Image /page/5/Picture/0 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in a simple, sans-serif font.
V. INDICATIONS FOR USE
The Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Uritek TC-201 Urine Analyzer and the Clinitek Status Plus Analyzer, a POC device currently sold in the US market, share the same technological characteristics including the analytical method, testing parameters, calibration method, and power requirements. They only differ in battery, language option, their memory size, dimensions and weight. The comparison is summarized in the following table:
| Proposed Device | Predicate | ||
|---|---|---|---|
| Trade Name | Uritek TC-201 Urine Analyzer | Clinitek Status Plus Urine Analyzer | |
| Intended Use | The device is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for the semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine. | The device is intended to be used together with Clinitek Multistix 10 SG Strips as a system for the semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine. | |
| Methodology | Reflectance Photometer | Reflectance Photometer | |
| Specimen Type | Urine | Same | |
| Chemistry Strips | Teco Diagnostics Urine Reagent (URS-10) Strips | Clinitek Multistix 10 SG | |
| Analytical | |||
| Method | The analyzer measures the | ||
| intensity of the light reflected from | |||
| the reagent pads of a urinalysis | Same | ||
| Testing | |||
| Parameters | Glucose, Bilirubin, Ketone, | ||
| Specific Gravity, Blood, pH, | |||
| Protein, Urobilinogen, Nitrite, and | |||
| Leukocytes | Glucose, Bilirubin, Ketone, | ||
| Specific Gravity, Blood, pH, | |||
| Protein, Urobilinogen, Nitrite, | |||
| and Leukocytes | |||
| Calibration | |||
| Method | Self-calibration with the white | ||
| reflective check area located at the | |||
| back of the test strip bed | Same | ||
| Operating | |||
| interface | Touch Screen | Same | |
| Entered | |||
| Parameter | Urine Color and Clarity, Patient | ||
| ID and Operator ID | Same | ||
| Printer | Built-in thermal printer | Same | |
| PC Port | Standard RS232 Serial Port, | ||
| USB Port | Same | ||
| Power | Input 100-240 VAC ± 20% and | ||
| 45-65Hz, output + 9V | Same | ||
| Battery Powered | |||
| Operation | None | 6 AA non-rechargeable alkaline | |
| batteries | |||
| Line Leakage | |||
| Current | 875 mg/dL Negative 0.0 – 0.5 mg/dL Small 0.5 - 1.5 mg/dL Bilirubin Moderate 1.75 - 3.0 mg/dL Large > 3.0 mg/dL 0.0 – 3.75 mg/dL Negative Trace 3.75 - 10.0 mg/dL Ketone 15 mg/dL 10.0 — 27.5 mg/dL 40 mg/dL 27.5 – 60.0 mg/dL 80 mg/dL > 60.0 mg/dL 0 - 7.5 Ery/uL Negative 7.5 - 21.25 Ery/uL Trace Blood Small 21.25 — 52.5 Ery/μL Moderate 52.5 - 170 Ery/uL Large > 170 Ery/uL 0.0 - 11.25 mg/dL Negative 11.25 - 26.25 mg/dL Trace Protein 30 mg/dL 26.25 - 65 mg/dL 100 mg/dL 65 - 200 mg/dL 300 mg/dL > 200 mg/dL Negative 0.0 - 0.075 mg/dL Nitrite > 0.075 mg/dL Positive Negative 0.0 – 11.25 ca cells/uL Trace 11.25 – 56.25 ca cells/uL Leukocyte Small 56.25 – 111.25 ca cells/µL |
Table: Measuring Range of Each Color Block of URS-10 Strips
111.25 - 406.25 ca cells/uL
Moderate
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| Large | > 406.25 ca cells/µL | |
|---|---|---|
| Urobilinogen | 0.2 mg/dL | 0.2 – 0.6 mg/dL |
| 1.0 mg/dL | 0.6 – 1.5 mg/dL | |
| 2.0 mg/dL | 1.5 – 3.0 mg/dL | |
| 4.0 mg/dL | 3.0 – 6.0 mg/dL | |
| 8.0 mg/dL | > 6.0 mg/dL | |
| pH | 5.0 | |
| 6.0 | 6.0 | |
| 6.5 | 6.5 | |
| 7.0 | 7.0 | |
| 7.5 | 7.5 | |
| 8.0 | 8.0 | |
| 8.5 | 8.5 | |
| SG | 1.005 | 1.005 |
| 1.010 | 1.010 | |
| 1.015 | 1.015 | |
| 1.020 | 1.020 | |
| 1.025 | 1.025 | |
| 1.030 | 1.030 |
C. Traceability and Stability:
Traceability and Expected Value:
Three levels of commercial urine controls that represent values as negative, low and high for all 10 URS parameters were used to assess the quality, the integrity and the stability of URS-10 strips during the manufacturing process and the storage of the strips. The package insert and certificate of analysis of these control solutions confirmed the specific target analyte concentration in each level. These controls were purchased from a commercially available supplier (HYCOR Biomedical), who sells their controls for standard testing throughout the world.
The expected ranges for all controls used for testing URS-10 strips are listed in the following table. Please see Appendix 18.D for the control details.
| Analyte | Level I | Level II | Level III |
|---|---|---|---|
| Glucose | $500 - \ge 1000$ mg/dL | 100 – 500 mg/dL | Negative |
| Bilirubin | Moderate to Large | Small to Moderate | Negative |
Table I: Urine Control Acceptable Range
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com
| Ketone | $40 - \ge 80$ mg/dL | Trace - 40 mg/dL | Negative |
|---|---|---|---|
| Specific Gravity | 1.010 - 1.030 | $\le 1.005$ - 1.020 | $\le 1.005$ - 1.015 |
| Blood | Moderate to Large | Trace to Moderate | Negative |
| Nitrite | Positive | Positive | Negative |
| Protein | $100 - \ge 300$ mg/dL | Negative to 30 mg/dL | Negative |
| Urobilinogen | $4.0 - \ge 8.0$ EU/dL | 0.2 - 1.0 EU/dL | 0.2 - 1.0 EU/dL |
| Leukocyte | Small to Large | Trace to Moderate | Negative |
| pH | 7.0 - 8.5 | 7.0 - 8.5 | 5.0 - 7.0 |
510(k) SUMMARY
Stability:
Although the Teco Diagnostics URS-10 strips (K970250) have already passed all the Stability studies and approved by FDA for commercial use but we are performing three types of stability studies to assess the stability of URS-10 reagent strips with our new Uritek TC-201 urine analyzer.
(1) Open bottle study:
To monitor URS-10 strip's integrity after the strip bottle has been opened for use, open bottle study was conducted. This study involves testing URS-10 strips once periodically on TC-201 device, for 13 weeks using commercial urine controls levels I, II and III. Three (3) lots of URS-10 strip bottles used in the Open-vial Study will have passed Quality Control inspection and are opened (seals broken) and stored at room temperature (15-30°C) and 20-30% humidity. The acceptance criteria was that the tested strips must read all controls within the expected ranges as listed in the package insert for ≥ 90 days (pass 13 weeks) to confirm the statement "Do not use after 90 days of breaking the foil" on the URS-10 strip bottle label.
(2) Accelerated stability study:
Besides being used for testing product's integrity, accelerated stability study is often carried out to assess the shelf-life of a new product, which is verified in real-time studies. Accelerated stability study involves testing URS-10 strips once per week periodically on TC-201 device, for 13 weeks using commercial urine controls levels I, II and III. Three (3) lots of URS-10 strip bottles used in the Accelerated stability study will have passed Quality Control inspection and are sealed and stored at 37 C ± 2 C oven and 20-30% humidity. The acceptance criteria was that the tested strips must read all controls within the expected ranges as listed in Table 18.3.1 for > 90 days (pass 13 weeks) to confirm the sealed URS-10 strips bottle shelf life of two (2) years at room temperature (15-30°C) with 20-30% humidity.
(3) Real-time shelf-life study:
A real time, temperature and humidity stability study is currently being performed on sealed bottles of URS-10 strips to validate the claims stated in the Accelerated Stability Studies. This
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study involves testing the URS-10 strips on TC-201 device using commercial urine control levels I, II and III for every six (6) months from the manufactured date, until 18 months. After the URS-10 strips has passed 18 months, test every three (3) months until the product fails or until 27 months (3 months after the stated expiration date). Three (3) lots of URS-10 strips used in the Real Time Shelf Life Study will have passed Quality Control inspection and are sealed and stored at room temperature (15-30℃) and 20-30% humidity. The current strip label has an expiration date of 2 years.
The acceptance criteria was that the tested strips must read all controls within the expected ranges as listed in the package insert in real-time through its expiration date in the conditions that the product will be stored: sealed bottle, room temperature (15-30℃)
Results of all the stability studies are summarized in the following table. Please see Appendix 18.E Stability Study Data for data table.
| URS-10
Strip Lot no. | Urine Control
Level | Stability Study | | |
|-------------------------|------------------------|-----------------|-----------------------|----------------------|
| | | Open Bottle | Accelerated stability | Real time Shelf Life |
| 63726 | Level I | Pass | Pass | Ongoing study |
| | Level II | Pass | Pass | Ongoing study |
| | Level III | Pass | Pass | Ongoing study |
| 63886 | Level I | Pass | Pass | Ongoing study |
| | Level II | Pass | Pass | Ongoing study |
| | Level III | Pass | Pass | Ongoing study |
| 64020 | Level I | Pass | Pass | Ongoing study |
| | Level II | Pass | Pass | Ongoing study |
| | Level III | Pass | Pass | Ongoing study |
Table: Stability Study Test Results
D. Detection Limit
Sensitivity Study was performed to determine the cutoff point concentration at which each analyte on the URS-10 strip changed from negative to the positive color blocks. Samples were prepared by spiking the specified analyte concentration into negative urine with a minimum of 4 levels across the measuring range for each color block. Each pool was then analyzed in replicates of 8 by 3 operators on each of the 3 individual strip lots (8 strips x 3 operators/ strip lots), for a total of 24 data points for each level. The cutoff point determination study for each color block for each analyte is defined as the lowest concentration at which >55% of the test results are positive.
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Image /page/19/Picture/0 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black.
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com
510(k) SUMMARY
The cut-off values and percentage sensitivity for each color block for individual analyte is summarized and demonstrated in the table below:
| Analyte | Color Block | Cut-off | % Positive Results |
|---|---|---|---|
| Glucose | 100 mg/dL | 75 mg/dL | 67% |
| 250 mg/dL | 212.5 mg/dL | 83% | |
| 500 mg/dL | 437.5 mg/dL | 83% | |
| 1000 mg/dL | 875 mg/dL | 75% | |
| Bilirubin | Small | 0.5 mg/dL | 59% |
| Moderate | 1.75 mg/dL | 87.5% | |
| Large | 3.0 mg/dL | 62.5% | |
| Ketone | Trace | 3.75 mg/dL | 71% |
| 15 mg/dL | 10 mg/dL | 71% | |
| 40 mg/dL | 27.5 mg/dL | 91% | |
| 80 mg/dL | 60 mg/dL | 75% | |
| Blood | Trace | 7.5 Ery/μL | 71% |
| Small | 21.25 Ery/μL | 75% | |
| Moderate | 52.5 Ery/μL | 67% | |
| Large | 170 Ery/μL | 71% | |
| Protein | Trace | 11.25 mg/dL | 91% |
| 30 mg/dL | 26.25 mg/dL | 75% | |
| 100 mg/dL | 65 mg/dL | 87% | |
| 300 mg/dL | 200 mg/dL | 87% | |
| Nitrite | Positive | 0.075 mg/dL | 58% |
| Leukocyte | Trace | 11.25 ca cells/µL | 58% |
| Small | 56.25 ca cells/µL | 67% | |
| Moderate | 111.25 ca cells/µL | 58% | |
| Large | 312.5 ca cells/µL | 67% | |
| Urobilinogen | 0.2 mg/dL | 0.2 mg/dL | 100% |
| 1.0 mg/dL | 0.8 mg/dL | 71% | |
| 2.0 mg/dL | 2.0 mg/dL | 90% | |
| 4.0 mg/dL | 3.5 mg/dL | 55% | |
| 8.0 mg/dL | 7.0 mg/dL | 85% | |
| pH | 5.0 | 5.0 | 96% |
| 6.0 | 6.0 | 100% | |
| 6.5 | 6.5 | 96% | |
| 7.0 | 7.0 | 96% | |
| 7.5 | 7.5 | 96% | |
| 8.0 | 8.0 | 96% | |
| 8.5 | 8.5 | 96% | |
| SG | 1.005 | 1.005 | 92% |
| 1.010 | 1.010 | 92% | |
| 1.015 | 1.015 | 92% | |
| 1.020 | 1.020 | 92% | |
| 1.025 | 1.025 | 92% | |
| 1.030 | 1.030 | 92% |
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E. Analytical Specificity
Endogenous and Exogenous Interference Study:
Potential endogenous interferents and drugs commonly found in urine were evaluated to assess the interfering effect of various substances on the performance of URS-10 strips on Uritek TC-201 Urine Analyzer. At least 2 levels of the listed interferents were added to the urine sample pools which were prepared at 3 concentrations for each urine chemistry analyte; negative, low positive and high positive. Each urine sample was tested with 3 replicates using Uritek TC-201 Urine Analyzer. Interference was defined as a change in output of ± 1 color blocks between spiked and unspiked control sample for all the URS parameters.
The concentrations of the potential interfering substances that did not have any influence on the test results are listed below:
| Potential Interfering Substance | Highest Concentration of substance tested
which demonstrated no Interference |
|---------------------------------|---------------------------------------------------------------------------------|
| Ascorbic Acid | 30 mg/dL |
| Ammonium Chloride | 200 mg/dL |
| Albumin | ≤125 mg/dL |
| Bilirubin | 8 mg/dL |
| Creatine | 10 mg/dL |
| Lithium Acetoacetate | ≤60 mg/dL |
| Calcium Chloride | 100 mg/dL |
| Citric Acid | 50 mg/dL |
| Creatinine | 200 mg/dL |
| D (+) Glucose | 1500 mg/dL |
| Glycine | 450 mg/dL |
| Hemoglobin | 10 mg/dL |
| Potassium Chloride | 1500 mg/dL |
| Sodium Chloride | 4000 mg/dL |
| Oxalic Acid | 35 mg/dL |
| Sodium Acetate | 25 mg/dL |
| Sodium Nitrate | 10 mg/dL |
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| Sodium Nitrite | 10 mg/dL |
|---|---|
| Sodium Phosphate | 500 mg/dL |
| Uric Acid | 150 mg/dL |
| Urea | 4000 mg/dL |
| Riboflavin | 10 mg/L |
| Theophylline | 100 mg/L |
| D (+) Galactose | 80 mg/dL |
| Fructose | 100 mg/dL |
| Lactose | 10 mg/dL |
| Leucocytes | 3000 cells/uL |
| Blood | 8.5) |
| Amoxicillin (≥ 100 mg/dL), Hypochlorite (≥ 0.6%), | |
| SG (> 1.030) | |
| Bilirubin | Blood (≥ 5%), Pyridium (≥ 50 mg/dL) |
| Formalin (≥ 185 mg/dL), Boric Acid (≥ 500 mg/dL), | |
| Acetylcysteine (≥ 67.5 mg/dL), Hypochlorite (≥ 0.6%) | |
| Urobilinogen | Blood (≥ 1%) |
| Hypochlorite (≥ 0.6%) | |
| SG | Albumin (≥ 200 mg/dL), Blood (≥ 1%) |
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| Nitrofurantoin (≥ 120 mg/dL) | -1 to -2 | |
|---|---|---|
| pH | SG (> 1.030), Sodium Bicarbonate (≥ 750 mg/dL), Sodium | |
| Phosphate (≥ 250 mg/dL), Creatinine (≥ 400 mg/dL) | +1 to +2 | |
| Ascorbic Acid (≥75 mg/dL), Calcium Chloride (≥ 275 mg/dL) | ||
| Citric Acid (≥ 75 mg/dL), Sodium Chloride (≥ 6000 mg/dL), | ||
| Oxalic Acid (≥ 70 mg/dL) | -1 to -2 | |
| Blood | Albumin (200 mg/dL), Hypochlorite (≥ 0.6%) | +2 |
| Acetylcysteine (≥ 67.5 mg/dL) | -1 | |
| Nitrite | Blood (≥ 1%), Hypochlorite (≥ 0.6%), Pyridium (≥ 50 mg/dL) | +1 |
| Leukocytes | Blood (≥ 1%), Pyridium (≥ 50 mg/dL) | +1 to +2, |
| Glucose (≥ 2000 mg/dL), Boric Acid (≥ 500 mg/dL), | ||
| Chloroquine (≥ 20 mg/dL), Amoxicillin (≥ 100 mg/dL), | ||
| Hypochlorite (≥ 0.6%) | -1, | |
| -1 to -2 | ||
| Ketone | Blood (≥ 5%), Acetylcysteine (≥ 67.5 mg/dL), Pyridium (≥ 50 | |
| mg/dL) | +1, +2 to +3 | |
| Hypochlorite (≥ 0.6%) | -1 to -2 |
pH Interference Study:
The sponsor performed an additional study to evaluate the effect of sample pH on the test results for the ten analytes in human urine. The study result shows that sample pH from 5.0 to 9.0 does not affect the test results for leukocytes, urobilinogen, ketone, pH, blood, nitrite, bilirubin and glucose. Samples with pH greater than 8.5 affected the protein test resulting in a false high result.
Specific Gravity Interference Study:
The sponsor performed an additional study to evaluate the effect of sample specific gravity on the test results for the ten analytes in human urine. The study result shows that sample specific gravity from 1.000 to 1.040 does not affect the test results for leukocytes, urobilinogen, ketone, blood, nitrite, bilirubin and glucose. Samples with specific gravity greater than 1.030 affected the pH and protein tests resulting in a false low result.
Based on the results of this testing the sponsor has included the effects from above interfering substances in the labeling as limitations of procedure.
F. Flex Study
Temperature and Humidity Study:
The environmental effect on the performance of Uritek TC-201 Urine Analyzer and URS-10 strips was evaluated by placing the strips in relative humidity of 80% environment at ≥30 C. These conditions were manufactured artificially in the Laminar Air Flow Cabinet by placing Hot Water Steam Bath and a Humidifier. Tests were performed at particular time-points at 0.1h. 8h. 16h and 24h using commercially available urine control solutions at Level I (High analyte concentration), Level II (Low analyte concentration) and Level III (Negative).
Uritek TC-201 Urine Analyzer was stable at 92% humidity for over 24h at 30 C. The acceptance criteria was that the tested strips must read all controls within the expected ranges as listed in Table 18.3.1. 5 replicates of strips tested passed for each control level. Please see Appendix 18.M Analyzer Operating Conditions Study Data for data tables.
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4. Comparison Study
A. Method Comparison with Predicate Device:
Three Point-of-Care (POC) Sites that represented the intended user sites of these devices were selected to perform the method comparison studies to evaluate the performance of the Teco Diagnostics Urinalysis Reagent Strip (URS-10) read by the Uritek TC-201 Urine Analyzer compared to the performance of the predicate method, Siemens Multistix 10 SG Reagent strip read by Siemens Clinitek Status+ Urine Analyzer. Each site randomly selected at least 115, unaltered patient samples to test on both device pairings. In order to evaluate the performance of the candidate device over the entire measuring range of each analyte, additional contrived samples (10% of the total samples) were tested resulting in up to 392 specimens evaluated at all sites. Three lots of Teco Diagnostics Urinalysis Reagent Strip (URS-10) and 3 units of Uritek TC-201 Urine Analyzer were used in the study (detailed information is provided in Appendix 18.L). Three operators at each site ran the samples.
An additional method comparison study was performed at POC Site I and Site II for a total of 91 clinical samples to demonstrate the substantial equivalence accuracy for all the URS parameters. Moreover a separate study was performed at Site I wherein the patient urine samples were prescreened at pH ≥ 8.0 using a standardized pH meter and then performed the method comparison study using Uritek TC-201 Urine Analyzer and Siemens Clinitek Status+ Urine Analyzer. The total number of patient urine specimens evaluated in the Method Comparison Study is 509. (392+91+26) Gender and unique patient identifiers were recorded for each sample tested. Testing results are summarized in the following tables.
| Glucose | Siemens Clinitek Status + Urine Analyzer | ||||||
|---|---|---|---|---|---|---|---|
| 3 Sites, N=509 | 1000 | 500 | 250 | 100 | Neg | Overall | |
| 1000 | 16 | 4 | 0 | 0 | 0 | 20 | |
| Uritek TC- | 500 | 4 | 37 | 0 | 0 | 0 | 41 |
| 201 Urine | 250 | 0 | 0 | 10 | 0 | 0 | 10 |
| Analyzer | 100 | 0 | 0 | 0 | 25 | 0 | 25 |
| Neg | 0 | 0 | 0 | 0 | 0 | 413 | 413 |
| Total | 20 | 41 | 10 | 25 | 413 | 509 | |
| Agreement within same | 80.00% | 90.24% | 100.0% | 100.0% | 100.0% | 98.43% | |
| color block (Exact Match) | (16/20) | (37/41) | (10/10) | (25/25) | (413/413) | (501/509) | |
| Agreement within ±1 color | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | |
| block | (20/20) | (37/41) | (10/10) | (25/25) | (413/413) | (509/509) |
Glucose concentration levels compared at a 98.43% overall exact match and a 100.0% overall agreement ±1 color block match between the Uritek TC-201 Urine Analyzer and Siemens Clinitek Status+ Analyzer.
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Image /page/25/Picture/0 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside. To the right of the hexagon is the text "Teco Diagnostics" in a sans-serif font.
| Bilirubin | Siemens Clinitek Status + Urine Analyzer | |||||
|---|---|---|---|---|---|---|
| 3 Sites, N=509 | 3+ | 2+ | 1+ | Neg | Overall | |
| Uritek TC- | ||||||
| 201 Urine | ||||||
| Analyzer | 3+ | 35 | 1 | 0 | 0 | 36 |
| 2+ | 0 | 31 | 0 | 0 | 31 | |
| 1+ | 0 | 0 | 51 | 5 | 56 | |
| Neg | 0 | 0 | 0 | 386 | 386 | |
| Total | 35 | 32 | 51 | 391 | 509 | |
| Agreement within same | ||||||
| color block (Exact Match) | 100.0% | |||||
| (35/35) | 96.88% | |||||
| (31/32) | 100.0% | |||||
| (51/51) | 98.72% | |||||
| (386/391) | 98.82% | |||||
| (503/509) | ||||||
| Agreement within ±1 color | ||||||
| block | 100.0% | |||||
| (35/35) | 100.0% | |||||
| (32/32) | 100.0% | |||||
| (51/51) | 100.0% | |||||
| (391/391) | 100.0% | |||||
| (509/509) |
Bilirubin concentration levels compared at a 98.82% overall exact match and a 100.0% overall agreement ±1 color block match between the Uritek TC-201 Urine Analyzer and Siemens Clinitek Status+ Analyzer.
| Ketone | Siemens Clinitek Status + Urine Analyzer | ||||||
|---|---|---|---|---|---|---|---|
| 3 Sites, N=509 | 80 | 40 | 15 | Trace | Neg | Overall | |
| 80 | 13 | 1 | 0 | 0 | 0 | 14 | |
| Uritek TC- | 40 | 0 | 18 | 1 | 0 | 0 | 19 |
| 201 Urine | |||||||
| Analyzer | 15 | 0 | 0 | 24 | 1 | 0 | 25 |
| TRA | 0 | 0 | 0 | 44 | 4 | 48 | |
| Neg | 0 | 0 | 0 | 1 | 402 | 403 | |
| Total | 13 | 19 | 25 | 46 | 406 | 509 | |
| Agreement within same | |||||||
| color block (Exact Match) | 100.0% | ||||||
| (13/13) | 94.74% | ||||||
| (18/19) | 96.0% | ||||||
| (24/25) | 95.65% | ||||||
| (44/46) | 99.01% | ||||||
| (402/406) | 98.43% | ||||||
| (501/509) | |||||||
| Agreement within ±1 color | |||||||
| block | 100.0% | ||||||
| (13/13) | 100.0% | ||||||
| (19/19) | 100.0% | ||||||
| (25/25) | 100.0% | ||||||
| (46/46) | 100.0% | ||||||
| (406/406) | 100.0% | ||||||
| (509/509) |
Ketone concentration levels compared at a 98.43% overall exact match and a 100.0% overall agreement ±1 color block match between the Uritek TC-201 Urine Analyzer and Siemens Clinitek Status+ Analyzer.
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Image /page/26/Picture/0 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black.
| Specific Gravity | Siemens Clinitek Status + Urine Analyzer | |||||||
|---|---|---|---|---|---|---|---|---|
| 3 Sites, N=509 | ≥1.030 | 1.025 | 1.020 | 1.015 | 1.010 | 1.030 | 57 | |
| 1.025 | 6 | 55 | 5 | 0 | 0 | 0 | 66 | |
| 1.020 | 0 | 21 | 112 | 10 | 0 | 0 | 143 | |
| 1.015 | 0 | 0 | 16 | 135 | 6 | 0 | 157 | |
| 1.010 | 0 | 0 | 0 | 8 | 40 | 7 | 55 | |
| 300 | 100 | 30 | Trace | Neg | Overall | |||
| >300 | 26 | 0 | 0 | 0 | 0 | 26 | ||
| 100 | 0 | 35 | 0 | 0 | 0 | 35 | ||
| Uritek TC-201 | ||||||||
| Urine Analyzer | 30 | 0 | 3 | 34 | 0 | 0 | 37 | |
| Trace | 0 | 0 | 2 | 46 | 6 | 54 | ||
| Neg | 0 | 0 | 0 | 3 | 354 | 357 | ||
| Total | 26 | 38 | 36 | 49 | 360 | 509 | ||
| Agreement within same | 100.0% | 92.11% | 94.44% | 93.88% | 98.33% | 97.25% | ||
| color block (Exact Match) | (26/26) | (35/38) | (34/36) | (46/49) | (354/360) | (495/509) | ||
| Agreement within ±1 color | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | ||
| block | (26/26) | (38/38) | (36/36) | (49/49) | (360/360) | (509/509) |
Protein concentration levels compared at a 97.25% overall exact match and a 100.0% overall agreement ±1 color block match between the Uritek TC-201 Urine Analyzer and Siemens Clinitek Status+ Analyzer.
| Urobilinogen | Siemens Clinitek Status + Urine Analyzer | ||||||
|---|---|---|---|---|---|---|---|
| 3 Sites, N=509 | >8.0 | 4 | 2 | 1 | 0.2 | Overall | |
| Uritek TC-201 | |||||||
| Urine Analyzer | >8.0 | 31 | 0 | 0 | 0 | 0 | 31 |
| 4.0 | 0 | 26 | 0 | 0 | 0 | 26 | |
| 2.0 | 0 | 0 | 22 | 0 | 0 | 22 | |
| 1.0 | 0 | 0 | 0 | 14 | 0 | 14 | |
| 0.2 | 0 | 0 | 0 | 2 | 414 | 416 | |
| Total | 31 | 26 | 22 | 16 | 414 | 509 | |
| Agreement within same color | |||||||
| block (Exact Match) | 100.0% | ||||||
| (31/31) | 100.0% | ||||||
| (26/26) | 100.0% | ||||||
| (22/22) | 87.5% | ||||||
| (14/16) | 100.0% | ||||||
| (414/414) | 99.61% | ||||||
| (507/509) | |||||||
| Agreement within ±1 color | |||||||
| block | 100.0% | ||||||
| (31/31) | 100.0% | ||||||
| (26/26) | 100.0% | ||||||
| (22/22) | 100.0% | ||||||
| (16/16) | 100.0% | ||||||
| (414/414) | 100.0% | ||||||
| (509/509) |
Urobilinogen concentration levels compared at a 99.61% overall exact match and a 100.0% overall agreement ±1 color block match between the Uritek TC-201 Urine Analyzer and Siemens Clinitek Status+ Analyzer.
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| pH | Siemens Clinitek Status + Urine Analyzer | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 3 Sites, N=509 | 8.5 | 8 | 7.5 | 7.0 | 6.5 | 6.0 | 5.0 | Overall | |
| Uritek | 8.5 | 36 | 0 | 0 | 0 | 0 | 0 | 0 | 36 |
| TC-201 | |||||||||
| Urine | 8.0 | 2 | 15 | 5 | 0 | 0 | 0 | 0 | 22 |
| Analyzer | 7.5 | 1 | 1 | 34 | 1 | 0 | 0 | 0 | 37 |
| 7.0 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | |
| 6.5 | 0 | 0 | 0 | 8 | 65 | 1 | 0 | 74 | |
| 6.0 | 0 | 0 | 0 | 0 | 11 | 89 | 8 | 108 | |
| 5.0 | 0 | 0 | 0 | 0 | 1 | 9 | 122 | 132 | |
| Total | 39 | 16 | 39 | 109 | 77 | 99 | 130 | 509 | |
| Agreement within | |||||||||
| same color block | |||||||||
| (Exact Match) | 92.31% | ||||||||
| (36/39) | 93.75% | ||||||||
| (15/16) | 87.18% | ||||||||
| (34/39) | 91.74% | ||||||||
| (100/109) | 84.42% | ||||||||
| (65/77) | 89.90% | ||||||||
| (89/99) | 93.85% | ||||||||
| (122/130) | 90.57% | ||||||||
| (461/509) | |||||||||
| Agreement within | |||||||||
| ±1 color block | 97.44% | ||||||||
| (38/39) | 100.0% | ||||||||
| (16/16) | 100.0% | ||||||||
| (39/39) | 100.0% | ||||||||
| (109/109) | 98.70% | ||||||||
| (76/77) | 100.0% | ||||||||
| (99/99) | 100.0% | ||||||||
| (130/130) | 99.61% | ||||||||
| (507/509) |
pH concentration levels compared at an 90.57% overall exact match and a 99.61% overall agreement ±1 color block match between the Uritek TC-201 Urine Analyzer and Siemens Clinitek Status+ Analyzer.
| Nitrite | Siemens Clinitek Status + Urine Analyzer | |||
|---|---|---|---|---|
| 3 Sites, N=509 | POS | NEG | Overall | |
| Uritek TC-201 | ||||
| Urine Analyzer | POS | 80 | 2 | 82 |
| NEG | 1 | 426 | 427 | |
| Total | 81 | 428 | 509 | |
| Agreement within same color | ||||
| block (Exact Match) | 98.77% | |||
| (80/81) | 99.53% | |||
| (426/428) | 99.41% | |||
| (506/509) | ||||
| Agreement within ±1 color block | N/A | N/A | N/A |
Nitrite concentration levels compared at a 99.41% overall exact match between the Uritek TC-201 Urine Analyzer and Siemens Clinitek Status+ Analyzer.
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Image /page/29/Picture/0 description: The image shows the logo for "Teco Diagnostics". The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in a sans-serif font.
| Leukocyte | Siemens Clinitek Status + Urine Analyzer | ||||||
|---|---|---|---|---|---|---|---|
| 3 Sites, N=509 | 3+ | 2+ | 1+ | Trace | Neg | Overall | |
| 3+ | 39 | 0 | 0 | 0 | 0 | 39 | |
| 2+ | 0 | 12 | 0 | 0 | 0 | 12 | |
| Uritek TC-201 | |||||||
| Urine Analyzer | 1+ | 0 | 1 | 49 | 0 | 0 | 50 |
| Trace | 0 | 0 | 1 | 27 | 7 | 35 | |
| Neg | 0 | 0 | 0 | 2 | 371 | 373 | |
| Total | 39 | 13 | 50 | 29 | 378 | 509 | |
| Agreement within same color | 100.0% | 92.31% | 98.00% | 93.10% | 98.15% | 97.84% | |
| block (Exact Match) | (39/39) | (12/13) | (49/50) | (27/29) | (371/378) | (498/509) | |
| Agreement within ±1 color | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | |
| block | (39/39) | (12/13) | (50/50) | (29/29) | (378/378) | (509/509) |
Leukocyte concentration levels compared at a 97.84% overall exact match and a 100% overall agreement ±1 color block match between the Uritek TC-201 Urine Analyzer and Siemens Clinitek Status+ Analyzer.
B. Matrix Comparison:
Not applicable.
5. Clinical Study:
Not applicable.
6. Expected Values/Reference Range:
Glucose: Small amounts of glucose are normally excreted by the kidney. J Concentrations as little as 0.1 g/dl glucose, read either at 10 or 30 seconds, may be significantly abnormal if found consistently. At 10 seconds, results should be interpreted qualitatively; for semi-quantitative results, read at 30 seconds only.
Bilirubin: Normally, no bilirubin is detectable in urine by even the most sensitive method. Even trace amounts of bilirubin are sufficiently abnormal to require further investigation. Atypical colors (colors produced which are different than the negative or positive color blocks shown on the Color Chart) may indicate that bilirubin derived bile pigments are present in the urine sample and are possibly masking the bilirubin reaction.
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Image /page/30/Picture/0 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black.
Ketone: Normally, no ketones are present in urine. Detectable levels of ketone may occur in urine during physiological stress conditions such as fasting, pregnancy, and frequent strenuous exercise. In starvation diets, or in other abnormal carbohydrate metabolism situation, ketones appear in the urine in excessively large amounts before serum ketones are elevated.
Specific Gravity: Random urine may vary in specific gravity from 1.003-1.040+. Twenty-four hour urine from normal adults with normal diets and normal fluid intake will have a specific gravity of 1.016-1.022.10
Blood: Any green spots or green color developing on the reagent area within 40 seconds is significant and the urine should be examined further. Blood is frequently, but not invariably found in the urine of menstruating females.
pH: The normal pH of urine can range from 4.5-8.0. The average pH values in healthy subjects is 6.0.3
Protein: In 24-hour urine, 1-14 mg/d of protein may be excreted by the normal kidney. A color matching any color block greater than trace indicates significant proteinuria. For urine with high specific gravity, the test area may most closely match the trace color block even though only normal concentrations of protein are present. Clinical judgment is needed to evaluate the significance of trace results.
Urobilinogen: In a healthy population, the normal urine urobilinogen range obtained with this test is 0.2-1.0 Ehrlich Unit/dL. A result of 2.0 EU/dL may be of clinical significance and the same patient sample should be evaluated further.
Nitrite: Normally no detectable amount of nitrite is present in urine. 3 The nitrite area will be positive in a proportion of cases of significant infection, depending on how long the urine specimens were retained in the bladder prior to collection. Retrieval of positive cases with the nitrite test range from as low as 40%, in instances where little bladder incubation occurred, to as high as 80% in instances where a minimum of 4 hours incubation occurred.
Leukocytes: Normal urine specimens generally yield negative results with this test. A trace result may be of questionable clinical significance and it is recommended that the test be repeated using a fresh sample from the same patient. Repeated trace and positive results are of clinical significance.
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References:
-
- Free, A.H and Free, H.M .: Urinalysis, Critical Discipline of Clinical Science. CRC Crit. Rev. Clin. Lab. Sci. 3(4): 481-531; (1972).
-
- Yoder, J.Adams, E.C., and Free. H.M .: Simultaneous Screening for Urinary Occult Blood, Protein, Glucose and pH. Amer. J. Med Tech. 31:285; (1965).
-
- Tietz, N.W .: Clinical Guide to Laboratory Tests; W.B. Saunders Company, (1976).
-
- Burtis, C.A. and Ashwood, E.R .: Tietz Textbook of Clinical Chemistry 200 Ed. 2205; (1994).
-
- Schersten, B. and Fritz, H.: Subnormal Levels of Glucose in Urine. JAMA 201:129-132; (1967).
-
- McGarry, J.D .: Lilly Lecture, 1978: New Perspectives in the Regulation of Ketogenesis. Diabetes 28: 517-523 May, (1978).
-
- Williamson, D.H.: Physiological ketoses, or Why Ketone Bodies? Postgrad. Med. J. (June Suppl.): 371-375: (1971).
-
- Paterson, P. et al.: Maternal and Fetal Ketone Concentrations in Plasma and Urine. Lancet: 862-865; April 22, (1967).
-
- Fraser, J. et al .: Studies with a Simplified Nitroprusside Test for Ketone Bodies in Urine, Serum, Plasma and Milk. Clin. Chem. Acta II: 372-378; (1965).
-
- Henry, J.B. et al .: Clinical Diagnosis and Management by Laboratory Methods, 17" Ed. Philadelphia: Saunders; (1979).
-
- Beer JH, Vogt A, Neftel K, et al. False positive results for leucocytes in urine dipstick test with common antibiotics. BMJ 313:25; (1996).
-
- Csako G. False positive results for ketone with the drug MESNA and other freesulfhydryl compounds, Clin Chem. (1987).
-
- Young, D.S., et al.: Effects of Drugs on Clinical Laboratory Tests. Clin. Chem. Vol. 18 (10): 1041-1303; 1972.
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Image /page/32/Picture/0 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside. To the right of the hexagon is the text "Teco Diagnostics" in black font.
IX. Conclusion:
Device verification and validation testing confirms that product specifications are met, which supports the intended use and technological characteristic as the predicate devices. The information provided supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.
The performance characteristics of the Uritek TC-201 Urine Analyzer with the Urine Reagent (URS-10) Strips were verified by were verified by precision study, linearity study, traceability study, stability study, detection limit study, specificity study, and flex study. Testing results indicate that the Uritek TC-201 Urine Analyzer and Urine Reagent (URS-10) Strips perform satisfactorily when used appropriately, as outlined in the package insert.
Method comparison study results demonstrate a substantial equivalency on performance between Uritek TC-201 with Urine Reagent (URS-10) Strips and the predicate device, Clinitek Status Plus Urine Analyzer with Clinitek Multistix 10 SG Strips. In summary, the results present here support the substantial equivalence to the predicate device.