TECO DIAGNOSTICS UTI DETECTION STRIPS

K100024 · Teco Diagnostics · JMT · Feb 17, 2011 · Clinical Chemistry

Device Facts

• Record ID: K100024
• Device Name: TECO DIAGNOSTICS UTI DETECTION STRIPS
• Applicant: Teco Diagnostics
• Product Code: JMT · Clinical Chemistry
• Decision Date: Feb 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1510
• Device Class: Class 1

Indications for Use

The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

Device Story

Device consists of firm plastic strips with two dry reagent pads; pads contain bibulous material saturated with chemically active substances. User dips strip into urine sample; chemical reactions produce color changes on pads. Nitrite test: Gram-negative bacteria convert nitrate to nitrite; nitrite reacts with p-arsanilic acid to form diazonium compound, which couples with 1,2,3,4-tetrahydrobenzo(h) quinolin to produce pink color. Leukocyte test: Leukocyte esterase catalyzes hydrolysis of indoxyl ester derivative; liberated indoxyl reacts with diazonium salt to produce beige-pink to purple color. Results obtained by visual comparison against color chart provided on foil pouch. Used by lay persons in home setting for UTI screening. Output provides qualitative indication of infection presence; assists users in identifying need for professional medical consultation.

Clinical Evidence

Clinical study conducted at point-of-care sites and with lay persons comparing Teco UTI Test Strips to predicate Multistix 10 SG. Study evaluated clinical accuracy and ability of inexperienced lay users to obtain results comparable to professionals. Results indicated lay users achieved performance comparable to professional users.

Technological Characteristics

Plastic test strips with two dry reagent pads; bibulous material saturated with chemical reagents. Nitrite detection via p-arsanilic acid/1,2,3,4-tetrahydrobenzo(h) quinolin coupling. Leukocyte detection via indoxyl ester hydrolysis/diazonium salt reaction. Visual readout via color chart. Storage 15-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Nitrite and Leukocytes in human urine to aid in screening for urinary tract infections (UTI). Intended for over-the-counter home use by lay persons.

Regulatory Classification

Identification

A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.

Predicate Devices

• Multistix 10 SG Reagent Strips for Urinalysis (K905396)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a black hexagon with the letters 'TC' in white inside. The letters are in a simple, sans-serif font and are stacked on top of each other. The hexagon is solid black, providing a strong contrast to the white letters. The overall design is simple and modern.

# FEB 1 7 2011

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92 .-

The Assigned 510(k) number is k100024

## Submitter's Identification:

Teco Diagnostics, Inc. 1268 N. Lakeview Avenue Anaheim, CA 92807

Tel: [phone] Fax: [phone]

Date Prepared: December 18, 2009

## Contact Person:

Dr. KC Chen

## Proprietary Name of the Device:

Teco Diagnostics UTI Test Strips

## Common Name:

Urine Reagent Strips (URS)

#### Regulation Section and Classification:

21 CFR § 862.1510 Nitrite (Non-Quantitative) Test System Leukocyte Peroxidase Test 21 CFR § 864.7675

Class I: Urinary Leukocytes, Nitrite

## Product Code:

Test, Urine Leukocyte LJX Nitrite (urinary, non-quantitative) test system JMT

## Medical Specialty:

Clinical Chemistry

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows a logo with the letters 'TC' in white, set against a black hexagon. The letters are bold and sans-serif, with the 'T' slightly taller than the 'C'. The hexagon provides a solid, geometric background that makes the letters stand out.

# Predicate Device:

Multistix 10 SG Reagent Strips for Urinalysis, K905396 Bayer Corporation, marketed by Bayer Corporation, located at Elkhart, IN 46515, USA.

# Device Description:

Teco Diagnostics UTI Test Strips provides tests for the qualitative determination of leukocytes and nitrite in urine. The product is a firm plastic strip to which is affixed two separate dry reagent pad areas that is used for urinalysis. The reagent pad areas are bibulous material saturated with chemically active substances. All UTI Test Strips are carefully packaged along with a desiccant in a sealed, foil pouch. The color chart for reading the strips is on the outside of the foil pouch. A package insert is packaged along with the foil pouch into a box. The package insert contains all the necessary product information.

Results of each test are based on the color produced from the reaction of each reagent pad area once the Urine Reagent Strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results with Teco Diagnostics UTI Test Strips can be obtained in clinically meaningful units directly by comparison with the color chart. The color blocks represent nominal values will vary around the nominal values.

## Intended Use:

The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

## Test Principles:

Nitrite: This test depends on the conversion of 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 diazonium compound in turn couples with 1,2,3,4-tetrahydrobenzo(h) quinolin to produce a pink color.

Leukocyte: 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 diazonium salt to produce a beige-pink to purple color.

## Substantial Equivalence:

The Teco Diagnostics UTI Test Strips for Leukocyte and Nitrite are substantially equivalent to the Bayer Multistix 10-SG Reagent Strips for Urinalysis (K905396).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a logo with the letters 'TC' in white, set against a black hexagon. The letters are bold and sans-serif, with the 'T' slightly overlapping the 'C'. The hexagon is oriented with one point facing downwards, creating a visually stable and recognizable mark. A thin black line is visible above the hexagon, possibly indicating the top edge of a document or page.

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

# Comparison of Characteristics with Predicate:

| | Teco Diagnostics UTI Test Strips | Bayer Multistix 10 SG Reagent<br>Strips |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the qualitative detection of Nitrite<br>and Leukocyte in urine as an aid in the<br>screening of urinary tract infection (UTI) | For qualitative detection of Glucose,<br>Bilirubin, Ketone, pH, Blood (Occult),<br>Specific Gravity, Protein,<br>Urobilinogen, Leukocyte and Nitrite in<br>urine to assist in diagnosis in kidney<br>function, liver function, metabolic<br>disorders and urinary tract infection. |
| Intended<br>Users | Lay persons, over-the-counter use | For professional use in point-of-care<br>urine testing |
| Specimen | Human Urine | Same |
| Materials<br>Provided | Plastic test strips affixed with reagent<br>pads | Same |
| Storage | 15 - 30°C | Same |
| Nitrite<br>Test Time | 60 seconds | Same |
| Leukocyte<br>Test Time | 2 minutes | Same |
| Nitrite<br>Parameter<br>Methodology | This test depends on the conversion of<br>nitrate to nitrite by the action of Gram-<br>negative bacteria in the urine. The<br>nitrite reacts with p-arsanilic acid to<br>from a diazonium compound in an acid<br>medium. The diazonium compound in<br>turn couples with 1,2,3,4-<br>tetrahydrobenzo(h) quinolin to produce<br>a pink color. | Same |
| Leukocyte<br>Parameter<br>Methodology | This test is based on the action of<br>esterase present in leukocytes, which<br>catalyzes the hydrolysis of an indoxyl<br>ester derivative. The indoxyl ester<br>liberated reacts with a diazonium salt to<br>produce a beige-pink to purple color. | Same |

The devices differ in their intended users. UTI Test Strips are intended for lay users over the counter, whereas Multistix 10 SG is intended for professional use in point-of-care clinical sites. The possible errors associated with lay user testing were investigated in a clinical, comparison study where both lay users and professional users tested the strips on the same sample. The study demonstrated that the strips were able to be read correctly and easily among lay users.

The predicate device, Multistix 10 SG, also tests eight other analytes, including Glucose, Bilirubin, Ketone, pH value, Blood (Occult), Specific Gravity, Protein and Urobilinogen, intended in the assisting the diagnosis in the areas of kidney function, liver function and metabolic disorders. However, these analytes are not used to aid in the diagnosis of urinary tract infection and the safety and effectiveness of Teco Diagnostics' UTI Test Strips are not affected by the drop of these test analytes.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a logo with the letters "TC" in a bold, sans-serif font. The letters are stacked, with "T" above "C". The logo is contained within a black hexagon. The letters "TC" are white, creating a contrast with the black background of the hexagon.

#### Summary of Clinical Tests Performed:

The clinical studies were conducted at Point of Care sites and with lay persons using the Teco Diagnostics UTI Test Strips versus Multistix 10 SG. Clinical data were presented evaluating clinical accuracy of results. Clinical study results indicate that the inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals when using the Teco Diagnostics UTI Test Strips and the legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396).

#### Summary of Laboratory Tests Performed:

The Laboratory studies were conducted in house and included sensitivity studies, reproducibility study, interference studies, stress study, and stability studies. The obtained laboratory data indicate that Teco Diagnostics UTI Test Strips run well and met all required performance characteristics.

#### Conclusion:

The performance characteristics of the Teco Diagnostics UTI Test Strips were verified by sensitivity study, reproducibility study, interference studies, and temperature stress study. Testing results indicate that Teco Diagnostics UTI Test Strips can perform satisfactorily when used according to the "Test Procedure" directions on the package insert.

The laboratory testing results and clinical studies demonstrated a substantial equivalency on performance between the Teco Diagnostics UTI Test Strips and a legally marketed product, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396), with similar product characteristics and intended use of aid in diagnosis in urinary tract infection.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus-like symbol with three abstract shapes resembling birds or leaves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Image /page/4/Picture/4 description: The image shows a date, which is February 17, 2011. The month is abbreviated as FEB. The day is 17, and the year is 2011. The date is written in a bold, sans-serif font.

TECO Diagnostics c/o Dr. KC Chen 1268 North Lakeview Avenue Anaheim, CA 92807

Re: k100024

> Trade Name: TECO Diagnostics UTI Test Strips Regulation Number: 21 CFR 862.1510 Regulation Name: Nitrite (Non-Quantitative) Test System. Regulatory Class: Class I: (meets the limitations of exemptions in 21 CFR 862,9(c)(9) Product Codes: JMT, LJX Dated: January 12, 2011 Received: February 02, 2011

Dear Dr. Chen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{5}------------------------------------------------

#### Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-fire no [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

# Indications for Use

510(k) Number (If Known): k100024

Device Name: Teco Diagnostics UTI Test Strips

Indications for Use:

The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use__ > (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Director Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k/00024

Page 1 of 1