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 862.1300](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1300) → NGA — Test, Follicle Stimulating Hormone (Fsh), Over The Counter

# NGA · Test, Follicle Stimulating Hormone (Fsh), Over The Counter

_Clinical Chemistry · 21 CFR 862.1300 · Class 1_

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

## Overview

- **Product Code:** NGA
- **Device Name:** Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- **Regulation:** [21 CFR 862.1300](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1300)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

## 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 |
| --- | --- | --- | --- | --- |
| [K070484](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGA/K070484.md) | QUANTRX FEMALE FERTILITY TEST | Quantrx Biomedical Corporation | Oct 22, 2007 | SESE |
| [K032002](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGA/K032002.md) | FERTELL FEMALE FERTILITY TEST | Genosis, Inc. | Oct 30, 2003 | SESE |

## Top Applicants

- Genosis, Inc. — 1 clearance
- Quantrx Biomedical Corporation — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com