URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

K160372 · Teco Diagnostics, Inc. · JIL · Jul 22, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160372
• Device Name: URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
• Applicant: Teco Diagnostics, Inc.
• Product Code: JIL · Clinical Chemistry
• Decision Date: Jul 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended 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.

Device Story

Uritek TC-201 is an automated, benchtop urinalysis system for point-of-care use. It processes Teco Diagnostics URS-10 reagent strips; strips contain ten reagent pads saturated with chemicals. The analyzer irradiates test pads with light; a photodiode detects reflectance at specific wavelengths. The device calculates results based on reflection rates; results are displayed on a touchscreen and printed via an internal thermal printer. Operators (clinicians/technicians) use the system to aid in diagnosing metabolic, kidney, urinary, and liver conditions. The device features self-calibration using a white reflective check area on the strip bed. It provides semi-quantitative results in one minute, facilitating immediate clinical decision-making.

Clinical Evidence

No clinical trials were performed. Evidence consists of analytical performance studies including precision (within-run, run-to-run, and point-of-care), linearity, detection limits, and interference testing. A method comparison study was conducted at three point-of-care sites comparing the Uritek TC-201 system to the Siemens Clinitek Status+ analyzer using 509 clinical urine samples (including 44 contrived samples). Results showed high agreement, with overall exact match rates for most analytes exceeding 90% and 100% agreement within ±1 color block.

Technological Characteristics

Reflectance photometer; uses Teco Diagnostics URS-10 reagent strips (bibulous pads on plastic). Self-calibration via white reflective check area. Dimensions: 7.25" x 10.5" x 6.5". Power: 100-240 VAC. Connectivity: serial computer interface. Complies with IEC 61010-1, IEC 61010-2-101 (electrical safety), and IEC 61326-1/2 (EMC).

Indications for Use

Indicated for point-of-care, in vitro diagnostic use to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function by semi-quantitatively detecting glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes in human urine.

Regulatory Classification

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.

Predicate Devices

• Siemens Clinitek Status Plus Analyzer (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 & 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.

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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 [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" (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 [phone] or [phone] 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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | |
| | 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, <i>in vitro</i> 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) | |
| | <span style="text-decoration: underline;"><b>Prescription Use</b></span> (Part 21 CFR 801 Subpart D) <input checked="true" type="checkbox"/> <input type="checkbox"/> 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. | |
| <b>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*</b> | |
| 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 |
| | [e-mail] |
| "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 [phone] 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: [phone] Fax: [phone]

Contact Person: Aquil Merchant, M.S. Research Scientist Email: [e-mail] | 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.

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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 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<br>Method | The analyzer measures the<br>intensity of the light reflected from<br>the reagent pads of a urinalysis | Same |
| Testing<br>Parameters | Glucose, Bilirubin, Ketone,<br>Specific Gravity, Blood, pH,<br>Protein, Urobilinogen, Nitrite, and<br>Leukocytes | Glucose, Bilirubin, Ketone,<br>Specific Gravity, Blood, pH,<br>Protein, Urobilinogen, Nitrite,<br>and Leukocytes | |
| Calibration<br>Method | Self-calibration with the white<br>reflective check area located at the<br>back of the test strip bed | Same | |
| Operating<br>interface | Touch Screen | Same | |
| Entered<br>Parameter | Urine Color and Clarity, Patient<br>ID and Operator ID | Same | |
| Printer | Built-in thermal printer | Same | |
| PC Port | Standard RS232 Serial Port,<br>USB Port | Same | |
| Power | Input 100-240 VAC ± 20% and<br>45-65Hz, output + 9V | Same | |
| Battery Powered<br>Operation | None | 6 AA non-rechargeable alkaline<br>batteries | |
| Line Leakage<br>Current | <0.5mA | <0.5mA | |
| Analyzer<br>Operating<br>Conditions | 18-30°C (64-86°F); 18%-80%<br>Relative Humidity (non-<br>condensing) | Same | |
| Memory | Store up to 2000 test results | Store up to 950 test results | |
| Display Language | English, Spanish, Chinese | English, Spanish | |
| Screen Display | Color | Mono-tone | |
| Dimensions | Width 7.25 in<br>Depth 10.5 in<br>Height 6.5 in | Width 6.7 in<br>Depth 10.7 in<br>Height 6.2 in | |
| Weight | 1.88kg (4.14 lbs) | 1.66kg (3.65 lbs) | |

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

# 510(k) SUMMARY

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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 the hexagon. To the right of the hexagon is the text "Teco Diagnostics" in black.

The Teco Diagnostics Urine Reagent (URS-10) Strips and Clinitek Multistix 10 SG Strips share the same characteristics including Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte methodologies.

#### VII TEST PRINCIPLE

Glucose: This test is based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the reaction in which glucose is oxidized to produce gluconic acid and hydrogen peroxide. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with potassium iodide chromogen in which the chromogen is oxidized to different colors ranging from blue-green to greenish-brown through brown and dark brown.

Bilirubin: This test is based on the coupling of bilirubin with a diazotized dichioroaniline in a strongly acid medium. Varying bilirubin levels will produce light tan to reddish brown color proportional to its concentration in urine.

Ketone: This test is based on the reaction of acetoacetic acid with sodium nitroprusside in a strongly basic medium. The colors range from beige or buff-pink color for a "Negative" reading to pink and pink-purple for a "Positive" reading.

Specific Gravity: This test is based on the apparent pKa change of certain pretreated polyelectrolytes in relation to the ionic concentration. In the presence of an indicator, the colors range from dark blue or blue-green in urine of low ionic concentration to green and yellow-green in urine of higher ionic concentration.

Blood: This test is based on the pseudoperoxidase action of hemoglobin and erythrocytes which catalyzes the reaction of 3,3,5,5 '-tetramethyl-benzidine and buffered organic peroxide. The resulting colors range from orange to yellow-green and dark green. Very high blood concentration may cause the color development to continue to dark blue.

pH: This test is based on the well-known double pH indicator method, where bromothymol blue and methyl red give distinguishable colors over the pH range of 5-9. The colors range from redorange to yellow and yellow-green to blue-green.

Protein: This test is based on the protein error-of-indicator principle. At a constant pH, the development of any green color is due to the presence of protein. Colors range from yellow for a "Negative" reaction to yellow-green and green to blue-green for a "Positive" reaction.

Urobilinogen: This test is based on a modified Ehrlich reaction in which pdiethylaminobenzaldehyde reacts with urobilinogen in a strongly acid medium. Colors range from light pink to bright magenta.

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Image /page/8/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. The text is in a simple, sans-serif font.

Nitrite: This test depends on the conversion of nitrate to nitrite by the action of Gram negative bacteria in the urine. The nitrite reacts with p-arsanilic acid to from a diazonium compound in an acid medium. The diazoniumn compound in turn couples with 1,2,3,4- tetrahydrobenzo(h) quinolin to produce a pink color.

Leukocytes: This test is based on the action of esterase present in leukocytes, which catalyzes the hydrolysis of an indoxyl ester derivative. The indoxyl ester liberated reacts with a diazoniumn salt to produce a beige-pink to purple color.

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Image /page/9/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.

## VIII. SUMMARY OF PERFORMANCE TESTING

#### 1. Software

The software development, verification, and validation 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 Premarket 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 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 Analyzer with the Teco Diagnostics Urine Reagent (URS-10) Strips was verified by Precision Study, Sensitivity Study, Stability Study, Interference Study and Flex Study. The analytical testing and comparison testing are detailed in Performance Testing - Bench Section 18 of the submission. Below are the summaries of the testing results:

#### A. Precision Study:

#### i) In-house Precision Study:

Within Run Precision of Uritek TC-201 Urine Analyzer with the Teco Diagnostics Urine Reagent Strips (URS-10) was evaluated using commercially available urine control solutions at Level I (High analyte concentration), Level II (Low analyte concentration) and Level III (Negative). The package insert and certificate of analysis of these control solutions confirmed the specific target analyte concentration in each level. The repeatability of the Uritek TC-201 Urine Analyzer was evaluated by testing each level of control solution by three operators on three analyzers in replicates of 20 per run per day with three strip lots. A total of 180 strips were used for each level control solution tested (20 strips x 3 strip lots x 1 day x 3operators/analyzers = 180 tests per control).

As shown in the following tables, all analytes read 100% within the expected results +/- one color block. Please see Appendix 18.B for In-House Precision Study Data tables. The results from the Within-Run Precision study are summarized below:

| Analyte | Level | Exact Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|---------|------------|--------------------------|------------------------------|---------------------------------|-------------------------------------|-----|
| Glucose | 1000 mg/dL | 177/180 | 98.33 | 180/180 | 100 | 180 |

#### Urine Control Level I

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Image /page/10/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: [phone] Toll Free: 1-800-222-9880 Fax: [phone] www.tecodiagnostics.com

#### 510(k) SUMMARY

| Bilirubin | Large | 177/180 | 98.33 | 180/180 | 100 | 180 |
|------------------|-----------|---------|-------|---------|-----|-----|
| Ketone | 80 mg/dL | 179/180 | 99.44 | 180/180 | 100 | 180 |
| Specific Gravity | 1.015 | 176/180 | 97.78 | 180/180 | 100 | 180 |
| Blood | Large | 180/180 | 100 | 180/180 | 100 | 180 |
| Nitrite | Positive | 180/180 | 100 | 180/180 | 100 | 180 |
| Protein | 300 mg/dL | 180/180 | 100 | 180/180 | 100 | 180 |
| Urobilinogen | 8.0 EU/dL | 180/180 | 100 | 180/180 | 100 | 180 |
| Leukocyte | Large | 180/180 | 100 | 180/180 | 100 | 180 |
| pH | 8.0 | 173/180 | 96.11 | 180/180 | 100 | 180 |

#### Urine Control Level II

| Analyte | Level | Exact<br>Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|-----|
| Glucose | 250 mg/dL | 179/180 | 99.44 | 180/180 | 100 | 180 |
| Bilirubin | Small | 180/180 | 100 | 180/180 | 100 | 180 |
| Ketone | 40 mg/dL | 180/180 | 100 | 180/180 | 100 | 180 |
| Specific Gravity | 1.010 | 178/180 | 98.89 | 180/180 | 100 | 180 |
| Blood | Moderate | 180/180 | 100 | 180/180 | 100 | 180 |
| Nitrite | Positive | 180/180 | 100 | 180/180 | 100 | 180 |
| Protein | Trace | 179/180 | 99.44 | 180/180 | 100 | 180 |
| Urobilinogen | 0.2 EU/dL | 180/180 | 100 | 180/180 | 100 | 180 |
| Leukocyte | Moderate | 178/180 | 98.89 | 180/180 | 100 | 180 |
| pH | 8.0 | 179/180 | 99.44 | 180/180 | 100 | 180 |

#### Urine Control Level III

| Analyte | Level | Exact<br>Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|------------------|----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|-----|
| Glucose | Negative | 180/180 | 100 | 180/180 | 100 | 180 |
| Bilirubin | Negative | 180/180 | 100 | 180/180 | 100 | 180 |
| Ketone | Negative | 180/180 | 100 | 180/180 | 100 | 180 |
| Specific Gravity | 1.010 | 179/180 | 99.44 | 180/180 | 100 | 180 |
| Blood | Negative | 180/180 | 100 | 180/180 | 100 | 180 |
| Nitrite | Negative | 180/180 | 100 | 180/180 | 100 | 180 |

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Image /page/11/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 slightly larger than the letters inside the hexagon.

| Protein | Negative | 180/180 | 100 | 180/180 | 100 | 180 |
|--------------|-----------|---------|-------|---------|-----|-----|
| Urobilinogen | 0.2 EU/dL | 180/180 | 100 | 180/180 | 100 | 180 |
| Leukocyte | Negative | 180/180 | 100 | 180/180 | 100 | 180 |
| pH | 6.0 | 178/180 | 98.89 | 180/180 | 100 | 180 |

The Run to Run precision of Uritek TC-201 Urine Analyzer with the Teco Diagnostics Urine Reagent Strips (URS-10) was evaluated by testing each level of control solution (negative, low positive, and high positive) by two operators with three lots of URS-10 strips in three replicate assays per run, 2 non- consecutive runs each day for over 10 days on 2 Uritek TC-201 Urine Analyzer. Run 1 and Run 2 were separated by atleast 1 hour. A total of 120 strips were used for each level control solution tested (3 strips x 2 run x 10 days x 2 operators/analyzers/strip lots = 120 tests per control).

As shown in the following tables, all analytes read 100% within the expected results +/- one color block. Please see Appendix 18.B for In-House Precision Study Data tables. The results from the Run to Run Precision study are summarized below:

| Analyte | Level | Exact Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|------------------|------------|--------------------------|------------------------------|---------------------------------|-------------------------------------|-----|
| Glucose | 1000 mg/dL | 120/120 | 100 | 120/120 | 100 | 120 |
| Bilirubin | Large | 119/120 | 99.17 | 120/120 | 100 | 120 |
| Ketone | 80 mg/dL | 120/120 | 100 | 120/120 | 100 | 120 |
| Specific Gravity | 1.015 | 118/120 | 98.33 | 120/120 | 100 | 120 |
| Blood | Large | 120/120 | 100 | 120/120 | 100 | 120 |
| Nitrite | Positive | 120/120 | 100 | 120/120 | 100 | 120 |
| Protein | 300 mg/dL | 120/120 | 100 | 120/120 | 100 | 120 |
| Urobilinogen | 8.0 EU/dL | 120/120 | 100 | 120/120 | 100 | 120 |
| Leukocyte | Large | 120/120 | 100 | 120/120 | 100 | 120 |
| pH | 8.0 | 117/120 | 97.50 | 120/120 | 100 | 120 |

#### Urine Control Level I

Urine Control Level II

| Analyte | Level | Exact<br>Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|---------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|-----|
| Glucose | 250 mg/dL | 120/120 | 100 | 120/120 | 100 | 120 |

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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: [phone] Toll Free: 1-800-222-9880 Fax: [phone] www.tecodiagnostics.com

#### 510(k) SUMMARY

| Bilirubin | Small | 120/120 | 100 | 120/120 | 100 | 120 |
|------------------|-----------|---------|-------|---------|-----|-----|
| Ketone | 40 mg/dL | 120/120 | 100 | 120/120 | 100 | 120 |
| Specific Gravity | 1.010 | 117/120 | 97.50 | 120/120 | 100 | 120 |
| Blood | Moderate | 120/120 | 100 | 120/120 | 100 | 120 |
| Nitrite | Positive | 120/120 | 100 | 120/120 | 100 | 120 |
| Protein | Trace | 119/120 | 99.17 | 120/120 | 100 | 120 |
| Urobilinogen | 0.2 EU/dL | 120/120 | 100 | 120/120 | 100 | 120 |
| Leukocyte | Moderate | 120/120 | 100 | 120/120 | 100 | 120 |
| pH | 8.0 | 119/120 | 99.17 | 120/120 | 100 | 120 |

#### Urine Control Level III

| Analyte | Level | Exact<br>Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|-----|
| Glucose | Negative | 120/120 | 100 | 120/120 | 100 | 120 |
| Bilirubin | Negative | 120/120 | 100 | 120/120 | 100 | 120 |
| Ketone | Negative | 120/120 | 100 | 120/120 | 100 | 120 |
| Specific Gravity | 1.010 | 120/120 | 100 | 120/120 | 100 | 120 |
| Blood | Negative | 120/120 | 100 | 120/120 | 100 | 120 |
| Nitrite | Negative | 120/120 | 100 | 120/120 | 100 | 120 |
| Protein | Negative | 120/120 | 100 | 120/120 | 100 | 120 |
| Urobilinogen | 0.2 EU/dL | 120/120 | 100 | 120/120 | 100 | 120 |
| Leukocyte | Negative | 120/120 | 100 | 120/120 | 100 | 120 |
| pH | 6.0 | 120/120 | 100 | 120/120 | 100 | 120 |

## ii) Point-of-Care Precision Study:

The precision of Uritek TC-201 Urine Analyzer at point-of-care (POC) sites was evaluated using commercially available urine control solutions at Level I (High analyte concentration), Level II (Low analyte concentration) and Level III (Negative). The package insert and certificate of analysis of these control solutions confirmed the specific target analyte concentration in each level. The three level control solutions were dispensed in to different containers and were randomly labeled with numbers. Each sample was tested in duplicates per run, two runs per day for 10 days (N = 40 testing per sample).

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## POC sites

## Site 1: Clinica Medica Del Sagrado Corazon

831 S. Harbor Blvd. Anaheim, CA 92805 Doctor: Rouben Calatian MD

#### Site 2: Clinica Medica San Miquel

1306 W. Santa Ana Blvd., Santa Ana, CA 92703 Doctor: Martin Bande MD

## Site 3: Artritis & Osteoporosis Center

2601 Cornerstone Blvd, Edinburg, TX 78539 Doctor: Jorge C Zamora-Quezada MD

#### Precision procedures provided to each POC site

Please see Appendix 18.A Precision Study Protocol for POC Sites for the detail.

#### Results for Point-of-Care Precision:

As shown in the following tables, all analytes read 100% within the expected results +/- one color block. Please see Appendix 18.C for Point-of-Care Run to Run Precision Data tables.

Analyte Levels Tested:

| Analyte | Target Concentration | | |
|------------------|----------------------|-----------|-----------|
| | Level I | Level II | Level III |
| Glucose | 1000 mg/dL | 250 mg/dL | Negative |
| Bilirubin | Large | Small | Negative |
| Ketone | 80 mg/dL | 40 mg/dL | Negative |
| Specific Gravity | 1.015 | 1.010 | 1.010 |
| Blood | Large | Moderate | Negative |
| Nitrite | Positive | Positive | Negative |
| Protein | 300 mg/dL | Trace | Negative |
| Urobilinogen | 8.0 EU/dL | 0.2 EU/dL | 0.2 EU/dL |
| Leukocyte | Large | Moderate | Negative |
| pH | 8.0 | 8.0 | 6.0 |

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Results Summary:

Three POC sites combined:

| Analyte | Control Level I | | Control Level II | | Control Level III | |
|------------------|---------------------|-------------------------------------|---------------------|-------------------------------------|-------------------|-------------------------------------|
| | Exact Match | Match within<br>$\pm$ 1 color block | Exact Match | Match within<br>$\pm$ 1 color block | Exact Match | Match within<br>$\pm$ 1 color block |
| Glucose | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |
| Bilirubin | 100%<br>(120/120) | 100%<br>(120/120) | 99.17%<br>(119/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |
| Ketone | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |
| Specific Gravity | 99.17%<br>(119/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |
| Blood | 100%<br>(120/120) | 100%<br>(120/120) | 99.17%<br>(119/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |
| Nitrite | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |
| Protein | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |
| Urobilinogen | 99.17%<br>(119/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |
| Leukocyte | 100%<br>(120/120) | 100%<br>(120/120) | 99.17%<br>(119/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |
| pH | 98.33%<br>(118/120) | 100%<br>(120/120) | 98.33%<br>(118/120) | 100%<br>(120/120) | 100%<br>(120/120) | 100%<br>(120/120) |

## B. Linearity/Assay Reportable Range

A study to evaluate the reportable range for each analyte color block on the Teco Diagnostics Urine Reagent Strips (URS-10) was performed by measuring negative urine and negative urine spiked with known increasing and decreasing concentrations of analytes relative to each color block covering the entire measuring range of each analyte present on the URS-10 strip. Sample measurement was performed in replicates of 8 by 3 operators on each of 3 individual strip lots (8 strips x 3 operators/ strip lots), for a total of 24 measurements for every sample tested. A pH meter was used to confirm the pH results. The specific gravity values were confirmed by a

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clinical, handheld refractometer. Specific gravity measurements were performed in replicates of 8 by 3 operators on each of 3 individual strip lots (8 strips x 3 operators/ strip lots), for a total of 24 measurements for every sample tested.

The measuring range for each concentration color block is listed in the following table based on the results of Detection Limit Study in section 18.3. Please refer to Appendix 18.F for data tables.

Color Block Output Units Measuring Range Analyte 0.0 - 75 mg/dL Negative 75 – 212.5 mg/dL 100 mg/dL 250 mg/dL 212.5 - 437.5 mg/dL Glucose 500 mg/dL 437.5 - 875 mg/dL 1000 mg/dL > 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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Image /page/17/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 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

| Ketone | $40 - \ge 80$ mg/dL | Trace - 40 mg/dL | Negative |
|------------------|-----------------------|----------------------|---------------------|
| Specific Gravity…