URITEST - NITRITE IN URINE TEST

K954685 · Tcpi, Inc. · JMT · Jul 22, 1996 · Clinical Chemistry

Device Facts

• Record ID: K954685
• Device Name: URITEST - NITRITE IN URINE TEST
• Applicant: Tcpi, Inc.
• Product Code: JMT · Clinical Chemistry
• Decision Date: Jul 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1510
• Device Class: Class 1

Indications for Use

UriTest- Nitrite in Urine is a nonquantitative test to identify nitrite in urine. Nitrite identification is used for the detection of Urinary Tract Infection.

Device Story

Reagent strip test for detection of nitrite in urine; indicates presence of organisms associated with urinary tract infections. Principle: chemical reaction where nitrite in urine reacts with arsanilic acid to form a diazonium salt, which couples with N-1-naphthylethylendiamine dihydrochloride to produce a pink-red color change. Used by professional clinicians and lay users (home/point-of-care). Visual color comparison against a reference chart provides qualitative results. Positive result suggests presence of nitrite-producing bacteria, aiding clinical decision-making for UTI diagnosis.

Clinical Evidence

Clinical trial compared UriTest to Bayer Multistix. Professional user study (n=101): 100% sensitivity, 91.76% specificity, 93.07% accuracy. Lay user study (n=101): 100% sensitivity, 89.41% specificity, 91.09% accuracy. Spiked sample study (n=33) showed 100% agreement with predicate.

Technological Characteristics

Reagent strip impregnated with 25% w/w Arsanilic Acid, 10% w/w N-1-Naphthylethylendiamine Dihydrochloride, and 65% w/w Tartaric Acid. Colorimetric detection principle. Manual visual interpretation.

Indications for Use

Indicated for the detection of nitrite in urine as an aid in the diagnosis of urinary tract infections in both professional and lay user populations.

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- Reagent Strip for Urinalysis (Bayer Diagnostics)
• CHEMSTRIP - Urine Test Strip (Boehringer Mannheim)

Submission Summary (Full Text)

{0}

JUL 22
K95-4685/A5

# 510k Summary

Date of Summary: July 2, 1996

## DUPLICATE

**Product Name:**
Uri-Test - Nitrite in Urine

**Product Brand Name:**
Health Check - Health Check is a subsidiary of TCPI

**Sponsor's Name:**
TCPI - Technical Chemical and Products, Inc.
2241 SOUTH W. 15th ST.
POMPANO BEACH, FL 33069

**CORRESPONDENT:**
MDC ASSOCIATES
Fran White
Regulatory Consultant
15 Oak Street
Beverly Farms, Ma 01915

**SUBSTANTIALLY EQUIVALENT DEVICES:**

Product: MULTISTIX- Reagent Strip for Urinalysis
Manufactured by: Bayer Diagnostics

Product: CHEMSTRIP - Urine Test Strip
Manufactured by: Boehringer Mannheim

**PRODUCT DESCRIPTION:**

UriTest - Nitrite in Urine is a reagent strip test used to measure the presence of Nitrite in urine. Nitrite is produced by most organisms commonly associated with urinary tract infection. Nitrite is used to detect urinary tract infection.

**INTENDED USE:**

UriTest- Nitrite in Urine is a nonquantitative test to identify nitrite in urine. Nitrite identification is used for the detection of Urinary Tract Infection.

{1}

# SUMMARY OF TECHNOLOGY:

Like the predicate device, UriTest Nitrite in Urine test strips are impregnated with the appropriate chemicals (25% w/w Arsanilic Acid, 10% w/w N-1-Naphthylethylendiamine Dihydrochloride, 65% w/w Tartaric Acid). Nitrite if present in patient urine reacts with amine to give an diazonium salt, which couples sulfanilamide to yield a positive pink - red reaction.

# PERFORMANCE DATA:

A clinical trial was done to compare the performance of the UriTest to the Bayer Multistix. These data clearly demonstrate that the performance of the Uritest is substantially equivalent to the predicate device; Bayer Multistix.

Bayer vs. UriTest (Professional User)

| | Bayer + | Bayer - |
| --- | --- | --- |
| TCPI + | 16 | 7 |
| TCPI - | 0 | 78 |

Sensitivity = 100.00%
Specificity = 91.76%
Accuracy = 93.07%

Bayer vs. UriTest (Lay User)

| | Bayer + | Bayer - |
| --- | --- | --- |
| TCPI + | 16 | 9 |
| TCPI - | 0 | 76 |

Sensitivity = 100.00%
Specificity = 89.41%
Accuracy = 91.09%

{2}

To assure a sufficient number of positive specimens, a urine sample was spiked with bacteria. Spiked specimens were tested with both the UriTest - Nitrite in Urine and the Bayer Multistix. 100% agreement was observed.

## Spiked Samples

| | Bayer + | Bayer - |
| --- | --- | --- |
| TCPI + | 33 | 0 |
| TCPI - | 0 | 0 |

Sensitivity = 100.00%
Specificity = Not Valid
Accuracy = 100.00%

## STATEMENT OF SAFETY AND EFFICACY:

When compared to a Bayer Multistix and performed by untrained consumers, the product performance was as follows:

Sensitivity - 100%
Specificity - 89%
Accuracy - 90%

These data clearly demonstrate the safety and efficacy of the Uri-Test-Nitrite in Urine.

Technical Chemical and Products, Inc. confirm that any/all data provided in this submission may be released upon request.