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 862.1455](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1455) → JHF — Colorimetric Method, Lecithin/Sphingomyelin Ratio

# JHF · Colorimetric Method, Lecithin/Sphingomyelin Ratio

_Clinical Chemistry · 21 CFR 862.1455 · Class 2_

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

## Overview

- **Product Code:** JHF
- **Device Name:** Colorimetric Method, Lecithin/Sphingomyelin Ratio
- **Regulation:** [21 CFR 862.1455](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1455)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the lecithin/sphingomyelin ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat-like substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating fetal maturity.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K940817](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHF/K940817.md) | TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II | Abbott Laboratories | Feb 8, 1995 | SESE |
| [K883411](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHF/K883411.md) | PG-NUMERIC(TM) | Isolab, Inc. | Mar 15, 1989 | SESE |

## Top Applicants

- Abbott Laboratories — 1 clearance
- Isolab, Inc. — 1 clearance

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

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