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) → JHH — Electrophoretic Method, Lecithin/Sphingomyelin Ratio

# JHH · Electrophoretic 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/JHH

## Overview

- **Product Code:** JHH
- **Device Name:** Electrophoretic 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 (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/JHH](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHH)

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