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 862.1485](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1485) → NGE — Test, Luteinizing Hormone (Lh), Over The Counter

# NGE · Test, Luteinizing Hormone (Lh), Over The Counter

_Clinical Chemistry · 21 CFR 862.1485 · Class 1_

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

## Overview

- **Product Code:** NGE
- **Device Name:** Test, Luteinizing Hormone (Lh), Over The Counter
- **Regulation:** [21 CFR 862.1485](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1485)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

## 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K020808](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGE/K020808.md) | FERTILITE OV | Pheromone Sciences Corp. | Sep 23, 2002 | SESE |
| [K990223](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGE/K990223.md) | MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR | Unipath , Ltd. | Feb 24, 1999 | SESE |
| [K981207](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGE/K981207.md) | CLEARPLAN EASY FERTILITY MONITOR | Unipath , Ltd. | Oct 28, 1998 | SESE |
| [K973860](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGE/K973860.md) | OVULON MONITOR | Conception Technology, Inc. | Jan 7, 1998 | SESE |
| [K863121](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGE/K863121.md) | PEAK OVULATION PREDICTOR | Micron Technology, Inc. | Oct 14, 1986 | SESE |
| [K850579](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NGE/K850579.md) | CUE FERTILITY MONITOR | Zetek, Inc. | Mar 22, 1985 | SESE |

## Top Applicants

- Unipath , Ltd. — 2 clearances
- Conception Technology, Inc. — 1 clearance
- Micron Technology, Inc. — 1 clearance
- Pheromone Sciences Corp. — 1 clearance
- Zetek, Inc. — 1 clearance

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

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