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 862.1620](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1620) → QKE — Immunoassay, Pregnanediol Glucuronide, Over The Counter

# QKE · Immunoassay, Pregnanediol Glucuronide, Over The Counter

_Clinical Chemistry · 21 CFR 862.1620 · Class 1_

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

## Overview

- **Product Code:** QKE
- **Device Name:** Immunoassay, Pregnanediol Glucuronide, Over The Counter
- **Regulation:** [21 CFR 862.1620](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1620)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K191462](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QKE/K191462.md) | Proov Test | Mfb Fertility, Inc. | Feb 27, 2020 | SESE |

## Top Applicants

- Mfb Fertility, Inc. — 1 clearance

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

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