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.

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.

AI/ML Overview

The document describes the Uritek TC-201 Urine Chemistry Test System and its performance evaluation to establish substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document provides the following comparison study results for the Uritek TC-201 Urine Chemistry Test System against a predicate device:

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Albumin Result	Not explicitly stated	84.9% (n = 518) Accuracy
	Not explicitly stated	97.9% (n=335) Sensitivity
	Not explicitly stated	86.9% (n=183) Specificity
Creatinine Result	Not explicitly stated	83.4% (n = 518) Accuracy
Albumin to Creatinine Ratio	Not explicitly stated	89.9% (n=518) Accuracy
	Not explicitly stated	92.5% (n=255) Sensitivity
	Not explicitly stated	93.16% (n=263) Specificity

Note: The acceptance criteria are not explicitly stated in numerical form. The conclusion states that "product specifications are met" and that the data "supports the substantial equivalence to the predicate device." Therefore, the reported performance metrics are implicitly presented as meeting the unstated acceptance criteria for substantial equivalence.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: A total of 518 urine specimens were analyzed in the comparison study.
Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted at "three Point-of-Care sites," implying real-world clinical samples. While not explicitly stated as retrospective or prospective, the nature of a comparison study using collected specimens for analysis often points to a prospective collection for the study's purpose, though it cannot be definitively confirmed from the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number of experts used or their qualifications to establish the ground truth for the test set. The comparison study was conducted against a "predicate device" (Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis), which would have its own established accuracy and is used as the reference standard in this context.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison was primarily made against the results from the predicate device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
Effect Size of Human Readers with/without AI: Not applicable, as this device is an automated urinalysis system for chemical analysis, not an AI-assisted diagnostic imaging or interpretation system that involves human readers improving with AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the analytical performance and comparison studies described appear to be evaluations of the "algorithm only" or the device's automated performance (Urine Analyzer and Urine Microalbumin Creatinine Strips as a system). The Uritek TC-201 Urine Analyzer is an "automated, bench top instrument." The comparison study evaluates the system's performance in generating results compared to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the comparison study was established by the predicate device (Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis). The study compares the results from the Uritek TC-201 system to those obtained from the predicate device on the same urine specimens.

8. The sample size for the training set

The document does not explicitly state the sample size used for a training set. The provided information pertains to verification, validation, and a comparison study for the device's analytical performance. As a medical device for chemical analysis, training sets in the typical machine learning sense might not be directly applicable in the same way as for AI/ML-based diagnostic algorithms. Device calibration and internal validation would involve specific samples, but these are not termed "training sets" in this context.

9. How the ground truth for the training set was established

Since no specific "training set" is described for an AI/ML context, the method for establishing its ground truth is not applicable or provided. For the device itself, the "self-calibration with the white area located at the back of the test strip bed" is mentioned, which serves a calibration function.

Summary

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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)

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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

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Indications for Use

510(k) Number (if known) K152835

Device Name

Uritek TC-201 Urine Chemistry Test System

Indications for Use (Describe)

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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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:

1. 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).
1. Product Code: JFY - Enzymatic Method, Creatinine JIR - Indicator Method, Protein or Albumin (Urinary, Non-Quant.) KQO – Automated urinalysis system
1. 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

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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

ChemistryStrips	Urine Microalbumin CreatinineStrips (UAC)	Siemens Reagent Strips for Urinalysis
TestingParameters	Microalbumin, Creatinine	Microalbumin, Creatinine, Bilirubin,Blood (Occult), Glucose, Ketone,Leukocytes, Nitrite, pH, Protein,Specific Gravity, Urobilinogen, andhuman Chorionic Gonadotropin(hCG)
Micro-AlbuminMethodology	Indicator method based on dyebinding using a high affinitysulfonephthalein dye. At a constantpH, the development of a blue coloris due to the presence of Micro-Albumin. The resulting color rangesfrom pale green to aqua blue.	Same
CreatinineMethodology	Indicator method based on theperoxidase-like activity of a coppercreatinine complex that catalyze thereaction of diisopropylbenzenedihydroperoxide and 3', 3', 5', 5' -tetramethylbenzidine. The resultingcolor ranges from orange throughgreen to blue.	Same
DetectionRange	Detects albumin concentration from10mg/L to 150mg/LDetects creatinine concentrationfrom 10mg/dL to 300mg/dL	Same
CalculatedParameter	Albumin : Creatinine Ratio	Same
CalibrationMethod	Self-calibration with the white arealocated at the back of the test stripbed	Same
Operatinginterface	Touch Screen	Same
EnteredParameter	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 PortUSB Port
Power	Input 100-240 V $\pm$ 20% and 45-65Hz, output + 9V
Line LeakageCurrent	<0.5mA
AnalyzerOperatingConditions	18-30℃ (64-86°F); 18%-80%Relative Humidity (non-condensing)
BatteryPoweredOperation	None
Memory	Store up to 2000 test results
DisplayLanguage	English, Spanish, Chinese
ScreenDisplay	Color
Dimensions	Width 7.25 inDepth 10.5 inHeight 6.5 in
Weight	1.88kg (4.14 lbs)
	Same
	Same
	Same
	Same
	6 AA non-rechargeable alkalinebatteries
	Store up to 950 test results
	English, Spanish
	Mono-tone
	Width 6.7 inDepth 10.7 inHeight 6.2 in
	1.66kg (3.65 lbs)

VII. PERFORMANCE DATA

1. Software

The software development, verification were performed according to the Food and Drug Administration's guidance document. The contents of the software testing for this submission conform to the Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices as shown in Section 16 - Software.

2. Electrical Safety and Electromagnetic Compatibility

The Uritek TC-201 Urine Analyzer device complies with the applicable voluntary standards which include IEC 61010-1, IEC 61010-2-101, IEC 61326-1 and IEC 61326-2-6 for

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Image /page/8/Picture/0 description: The image contains 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.

Electromagnetic Compatibility and Safety. The Electrical Safety and EMC Report are included in the Electromagnetic Compatibility and Electrical Safety Section 17 of the submission.

3. 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. The testing results are detailed in Performance Testing - Bench Section 18 of the submission.

Laboratory test results indicate that the Uritek TC-201 Urine Chemistry Test System can safely and effectively perform with satisfaction when used according to the user manual of the analyzer and the package insert of the strip.

4. Comparison Study

The accuracy of Uritek TC-201 Urine Chemistry Test System was evaluated at three Point-of-Care sites by comparing the data using the predicate. A total of 518 urine specimens were analyzed. Method comparison study results indicate that the intended users were able to obtain comparable testing data when using the Uritek TC-201 Urine Chemistry Test System and the predicate device. The results are summarized in the following table:

	Accuracy	Sensitivity	Specificity
Albumin result	84.9% (n = 518)	97.9% (n=335)	86.9% (n=183)
Creatinine result	83.4% (n = 518)	N/A	N/A
Albumin toCreatinine Ratio	89.9% (n=518)	92.5% (n=255)	93.16% (n=263)

VII. CONCLUSIONS

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 laboratory test results and the method comparison studies results demonstrate a substantial equivalency on performance between Teco Diagnostics' Uritek TC-201 Urine Chemistry Test System and the predicate device when used appropriately, as outlined in the package insert.

In summary, the results present here support the substantial equivalence to the predicate device.

Regulation Number and Section

§ 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.