URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

K152835 · Teco Diagnostics, Inc. · JFY · Mar 7, 2016 · Clinical Chemistry

Device Facts

• Record ID: K152835
• Device Name: URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
• Applicant: Teco Diagnostics, Inc.
• Product Code: JFY · Clinical Chemistry
• Decision Date: Mar 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended 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.

Device Story

Uritek TC-201 is an automated, benchtop urinalysis system for professional POC use. It consists of the TC-201 analyzer and UAC reagent strips. The analyzer uses reflectance photometry to measure color intensity on reagent pads; it irradiates the strip with light and detects reflectance via photodiode. The system calculates microalbumin and creatinine concentrations and the albumin-to-creatinine ratio. Results are displayed on a touchscreen and printed via an internal thermal printer. The device aids clinicians in screening for microalbuminuria to identify patients at risk for kidney damage. It features a serial/USB interface for data management and stores up to 2000 results.

Clinical Evidence

No clinical studies performed. Performance established via bench testing and method comparison study. Method comparison tested 402 patient samples and 38 contrived samples (total 518) across three POC sites. Results showed high agreement with predicate device; exact agreement for albumin and creatinine ranged from 77.8% to 91.4% across blocks, with 100% agreement within ±1 block.

Technological Characteristics

Reflectance photometer; uses bibulous material reagent strips with dye-binding (microalbumin) and peroxidase-like copper complex (creatinine) chemistry. Self-calibration via white strip area. Power: 100-240V AC. Connectivity: RS232/USB. Dimensions: 7.25" x 10.5" x 6.5". Weight: 1.88kg. Software-controlled analysis.

Indications for Use

Indicated for professional use at Point-of-Care (POC) sites for the semiquantitative detection of microalbumin and creatinine and determination of albumin-to-creatinine ratio in urine specimens to screen for microalbuminuria as an aid in detecting patients at risk for kidney damage.

Regulatory Classification

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.

Predicate Devices

• Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis (k091216)

Submission Summary (Full Text)

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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)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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: [phone] Fax: [phone]

Contact Person: Yunyuan Vivian Wang, Ph. D. R&D Manager Email: [e-mail]

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).
- 2. Product Code: JFY - Enzymatic Method, Creatinine JIR - Indicator Method, Protein or Albumin (Urinary, Non-Quant.) KQO – Automated urinalysis system
- 3. 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.

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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: [phone] Toll Free: 1-800-222-9880 Fax: [phone] www.tecodiagnostics.com

## Section 5 -- 510(k) SUMMARY

| Chemistry<br>Strips | Urine Microalbumin Creatinine<br>Strips (UAC) | Siemens Reagent Strips for Urinalysis |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing<br>Parameters | Microalbumin, Creatinine | Microalbumin, Creatinine, Bilirubin,<br>Blood (Occult), Glucose, Ketone,<br>Leukocytes, Nitrite, pH, Protein,<br>Specific Gravity, Urobilinogen, and<br>human Chorionic Gonadotropin<br>(hCG) |
| Micro-<br>Albumin<br>Methodology | Indicator method based on dye<br>binding using a high affinity<br>sulfonephthalein dye. At a constant<br>pH, the development of a blue color<br>is due to the presence of Micro-<br>Albumin. The resulting color ranges<br>from pale green to aqua blue. | Same |
| Creatinine<br>Methodology | Indicator method based on the<br>peroxidase-like activity of a copper<br>creatinine complex that catalyze the<br>reaction of diisopropylbenzene<br>dihydroperoxide and 3', 3', 5', 5' -<br>tetramethylbenzidine. The resulting<br>color ranges from orange through<br>green to blue. | Same |
| Detection<br>Range | Detects albumin concentration from<br>10mg/L to 150mg/L<br>Detects creatinine concentration<br>from 10mg/dL to 300mg/dL | Same |
| Calculated<br>Parameter | Albumin : Creatinine Ratio | Same |
| Calibration<br>Method | Self-calibration with the white area<br>located at the back of the test strip<br>bed | Same |
| Operating<br>interface | Touch Screen | Same |
| Entered<br>Parameter | Urine Color and Clarity, Patient ID,<br>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: [phone] Toll Free: 1-800-222-9880 Fax: [phone] www.tecodiagnostics.com

#### Section 5 -- 510(k) SUMMARY

| PC Port | Standard RS232 serial Port<br>USB Port |
|-------------------------------------|-----------------------------------------------------------------|
| Power | Input 100-240 V $\pm$ 20% and 45-<br>65Hz, output + 9V |
| Line Leakage<br>Current | <0.5mA |
| Analyzer<br>Operating<br>Conditions | 18-30℃ (64-86°F); 18%-80%<br>Relative Humidity (non-condensing) |
| Battery<br>Powered<br>Operation | None |
| Memory | Store up to 2000 test results |
| Display<br>Language | English, Spanish, Chinese |
| Screen<br>Display | Color |
| Dimensions | Width 7.25 in<br>Depth 10.5 in<br>Height 6.5 in |
| Weight | 1.88kg (4.14 lbs) |
| | Same |
| | Same |
| | Same |
| | Same |
| | 6 AA non-rechargeable alkaline<br>batteries |
| | Store up to 950 test results |
| | English, Spanish |
| | Mono-tone |
| | Width 6.7 in<br>Depth 10.7 in<br>Height 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 to<br>Creatinine 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.