Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1510](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1510) → JMT — Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

# JMT · Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

_Clinical Chemistry · 21 CFR 862.1510 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT

## Overview

- **Product Code:** JMT
- **Device Name:** Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- **Regulation:** [21 CFR 862.1510](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1510)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251800](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K251800.md) | Healgen® URS Test Strips | Healgen Scientific,, LLC | Dec 23, 2025 | SESE |
| [K252607](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K252607.md) | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | Oct 30, 2025 | SESE |
| [K242767](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K242767.md) | Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. | Jan 10, 2025 | SESE |
| [K170118](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K170118.md) | Scanostics UTI Check Application Test System | Teco Diagnostics | Sep 21, 2017 | SESE |
| [K100024](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K100024.md) | TECO DIAGNOSTICS UTI DETECTION STRIPS | Teco Diagnostics | Feb 17, 2011 | SESE |
| [K993850](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K993850.md) | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | International Newtech Development, Inc. | Jan 3, 2000 | SESE |
| [K990873](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K990873.md) | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | Ameritek, Inc. | Sep 1, 1999 | SESE |
| [K954685](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K954685.md) | URITEST - NITRITE IN URINE TEST | Tcpi, Inc. | Jul 22, 1996 | SESE |
| [K960888](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K960888.md) | CHEK-STIX U.T.I. SELF-TEST | Bayer Corp. | Jul 5, 1996 | SESE |
| [K953672](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K953672.md) | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS | Polymer Technology Intl. | Jul 1, 1996 | SESE |
| [K875248](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K875248.md) | BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS | Bioscan Instruments, Inc. | Feb 24, 1988 | SESE |
| [K855238](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K855238.md) | BIOTEL (TM)/UTI | American Diagnostic Corp. | May 9, 1986 | SESE |
| [K840828](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K840828.md) | KYOTEST 8V | Kyoto Diagnostics, Inc. | May 14, 1984 | SESE |

## Top Applicants

- Teco Diagnostics — 2 clearances
- American Diagnostic Corp. — 1 clearance
- Ameritek, Inc. — 1 clearance
- Bayer Corp. — 1 clearance
- Bioscan Instruments, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT)

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