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) → PDS — Amniotic Fluid Protein Immunoassay

# PDS · Amniotic Fluid Protein Immunoassay

_Clinical Chemistry · 21 CFR 862.1550 · Class 1_

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

## Overview

- **Product Code:** PDS
- **Device Name:** Amniotic Fluid Protein Immunoassay
- **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)
- **3rd-party reviewable:** yes

## 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 (0 of 0)

_No cleared devices on record._

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

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