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 862.1550](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1550) → NQM — Immunoassay For Detection Of Amniotic Fluid Protein(S).

# NQM · Immunoassay For Detection Of Amniotic Fluid Protein(S).

_Clinical Chemistry · 21 CFR 862.1550 · Class 1_

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

## Overview

- **Product Code:** NQM
- **Device Name:** Immunoassay For Detection Of Amniotic Fluid Protein(S).
- **Regulation:** [21 CFR 862.1550](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1550)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K110605](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NQM/K110605.md) | ROM PLUS | Clinical Innovations, LLC | Nov 23, 2011 | SESE |
| [K081767](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NQM/K081767.md) | AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 | Amnisure International, LLC | Jan 9, 2009 | SESE |

## Top Applicants

- Amnisure International, LLC — 1 clearance
- Clinical Innovations, LLC — 1 clearance

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

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