(160 days)
Not Found
No
The device description details a system that uses light reflectance and photodiode detection to determine color intensity on reagent strips and calculate results based on a reflection rate. There is no mention of AI or ML algorithms being used for analysis, interpretation, or calculation. The performance studies focus on standard statistical metrics like accuracy, sensitivity, and specificity, which are typical for non-AI/ML diagnostic devices.
No.
The device is described as an in vitro diagnostic device used for the semiquantitative detection of Microalbumin and Creatinine in urine, which aids in the detection of patients at risk for developing kidney damage. It does not provide treatment or therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only." It is also indicated to aid in the detection of patients at risk for developing kidney damage through screening urine specimens.
No
The device description clearly states it consists of a "Urine Analyzer" which is an automated, bench top instrument that uses light and photodiodes to read reagent strips. This is a hardware component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only."
- Purpose: The device is designed to analyze biological specimens (urine) in vitro (outside the body) to provide information about a patient's health status (detection of microalbuminuria as an aid in the detection of patients at risk for developing kidney damage).
- Components: The system includes both an analyzer and reagent strips, which are typical components of IVD systems used for chemical analysis of biological fluids.
- Testing Method: The device uses chemical reactions on the reagent strips and optical detection (reflectance) to measure analytes in the urine, which is a standard method for in vitro diagnostic testing.
- Intended User and Setting: It is intended for use by professionals at Point-of-Care sites, which aligns with the use of IVD devices in clinical settings.
N/A
Intended Use / Indications for Use
Uritek TC-201 Urine Chemistry Test System consists of Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the semiquantitative detection of Microalbumin and Creatinine and determination of the albumin to creatinine ratio in urine. Test results may be used in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
Product codes (comma separated list FDA assigned to the subject device)
JFY, JIR, KQO
Device Description
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer (TC-201) is a portable easy to use instrument which reads Teco Diagnostics' Urine Microalbumin Creatinine (UAC) 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 microalbumin and creatinine. 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 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.
The Urine Microalbumin Creatinine (UAC) Strips are urine test strips of which microalbumin and creatinine reagent pad are affixed onto the firm plastic strips. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. UAC strips provide tests for the semi-quantitative detection of Microalbumin (low concentration of Albumin) and Creatinine and determination of the Albumin to Creatinine ratio (A : C) 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
It is intended for use only at Point-of-Care (POC) sites by professionals.
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:
The analytical performance of Uritek TC-201 Urine Chemistry Test System was verified by Precision Study, Sensitivity Study, Stability Study, Flex Study, Flex Study.
Comparison Study:
Study type: Method comparison study
Sample size: A total of 518 urine specimens.
Key results:
Albumin result: Accuracy 84.9% (n = 518), Sensitivity 97.9% (n=335), Specificity 86.9% (n=183)
Creatinine result: Accuracy 83.4% (n = 518)
Albumin to Creatinine Ratio: Accuracy 89.9% (n=518), Sensitivity 92.5% (n=255), Specificity 93.16% (n=263)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Albumin result: Accuracy 84.9% (n = 518), Sensitivity 97.9% (n=335), Specificity 86.9% (n=183)
Creatinine result: Accuracy 83.4% (n = 518)
Albumin to Creatinine Ratio: Accuracy 89.9% (n=518), Sensitivity 92.5% (n=255), Specificity 93.16% (n=263)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with two snakes intertwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2016
TECO DIAGNOSTICS, INC. YUNYUAN VIVIAN WANG R&D MANAGER 1268 N. LAKEVIEW AVE. ANAHEIM CA 92807
Re: K152835
Trade/Device Name: Uritek TC-201 Urine Chemistry Test System Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, JIR and KOO Dated: January 27, 2016 Received: January 28, 2016
Dear Dr. Yunyuan Vivian Wang:
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 8091); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS)
1
regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR 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 vours.
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
Indications for Use
510(k) Number (if known) K152835
Device Name
Uritek TC-201 Urine Chemistry Test System
Indications for Use (Describe)
Uritek TC-201 Urine Chemistry Test System consists of Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the semiquantitative detection of Microalbumin and Creatinine and determination of the albumin to creatinine ratio in urine. Test results may be used in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
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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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 font.
I. SUBMMITER
Applicant Information:
Teco Diagnostics, Inc. 1268 North Lakeview Avenue Anaheim, CA 92807 Phone: 714-463-1111 Fax: 714-463-1169
Contact Person: Yunyuan Vivian Wang, Ph. D. R&D Manager Email: vwang@tecodiag.com
Date Prepared: September 28th, 2015
II. DEVICE
Device Name: Uritek TC-201 Urine Chemistry Test System
Common Name:
Automated Urinalysis System, Urinary Test System
Regulatory Information:
-
- Regulation Classification section: Class II: 21 CFR 862.1225 - Creatinine test system Class I: 21 CFR 862.1645 - Urinary protein or albumin (nonquantitative) test system Class I: 21 CFR 862.2900 -Automated urinalysis system (exempt).
-
- Product Code: JFY - Enzymatic Method, Creatinine JIR - Indicator Method, Protein or Albumin (Urinary, Non-Quant.) KQO – Automated urinalysis system
-
- Panel: Clinical Chemistry
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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 font.
III. PREDICATE DEVICE
Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis SIEMMENS HEALTHCARE DIAGNOSTICS 2 Edgewater Dr. Norwood, MA 02062 510(k) Number: K091216
IV. DEVICE DESCRIPTION
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer (TC-201) is a portable easy to use instrument which reads Teco Diagnostics' Urine Microalbumin Creatinine (UAC) 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 microalbumin and creatinine. 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 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.
The Urine Microalbumin Creatinine (UAC) Strips are urine test strips of which microalbumin and creatinine reagent pad are affixed onto the firm plastic strips. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. UAC strips provide tests for the semi-quantitative detection of Microalbumin (low concentration of Albumin) and Creatinine and determination of the Albumin to Creatinine ratio (A : C) 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 the hexagon. To the right of the hexagon is the text "Teco Diagnostics" in black font. The text is slightly larger than the letters inside the hexagon.
V. INDICATIONS FOR USE
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the semiquantitative detection of Microalbumin and Creatinine and determination of the albumin to creatinine ratio in urine. Test results may be used in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICAATE DEVICE
The Uritek TC-201 Urine Chemistry Test System and the Clinitek Status Plus Analyzer with Clinitek Microalbumin Reagent Strips, a POC device currently sold in the US market, share the same technological characteristics including the analytical method, testing parameters, chemical methodology, calibration method, and power requirements. They only differ in test strips used, battery, language option, their memory size, dimensions and weight. The comparison is summarized in the following table:
| Similarities and Differences | ||
|---|---|---|
| Device | Predicate | |
| Trade Name | Uritek TC-201 Urine Chemistry Test System | Siemens Reagent Strips for Urinalysis |
| Intended Use | Intended for prescription, in vitro diagnostic use only. | Same |
| Specimen Type | Urine | Same |
| Device Methodology | Reflectance Photometer | Same |
| Analytical Method | The analyzer measures the intensity of the light reflected from the reagent pads of a urinalysis reagent strip. | Same |
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Image /page/6/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. The text is in a sans-serif font and is slightly larger than the letters inside the hexagon.
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
Section 5 -- 510(k) SUMMARY
| Chemistry
Strips | Urine Microalbumin Creatinine
Strips (UAC) | Siemens Reagent Strips for Urinalysis |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing
Parameters | Microalbumin, Creatinine | Microalbumin, Creatinine, Bilirubin,
Blood (Occult), Glucose, Ketone,
Leukocytes, Nitrite, pH, Protein,
Specific Gravity, Urobilinogen, and
human Chorionic Gonadotropin
(hCG) |
| Micro-
Albumin
Methodology | Indicator method based on dye
binding using a high affinity
sulfonephthalein dye. At a constant
pH, the development of a blue color
is due to the presence of Micro-
Albumin. The resulting color ranges
from pale green to aqua blue. | Same |
| Creatinine
Methodology | Indicator method based on the
peroxidase-like activity of a copper
creatinine complex that catalyze the
reaction of diisopropylbenzene
dihydroperoxide and 3', 3', 5', 5' -
tetramethylbenzidine. The resulting
color ranges from orange through
green to blue. | Same |
| Detection
Range | Detects albumin concentration from
10mg/L to 150mg/L
Detects creatinine concentration
from 10mg/dL to 300mg/dL | Same |
| Calculated
Parameter | Albumin : Creatinine Ratio | Same |
| Calibration
Method | Self-calibration with the white area
located at the back of the test strip
bed | Same |
| Operating
interface | Touch Screen | Same |
| Entered
Parameter | Urine Color and Clarity, Patient ID,
Operator ID | Same |
| Printer | Built-in thermal printer | Same |
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Image /page/7/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.
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
Section 5 -- 510(k) SUMMARY
| PC Port | Standard RS232 serial Port
USB Port |
|-------------------------------------|-----------------------------------------------------------------|
| Power | Input 100-240 V $\pm$ 20% and 45-
65Hz, output + 9V |
| Line Leakage
Current |