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) → JHG — Chromatographic Separation, Lecithin/Sphingomyelin Ratio

# JHG · Chromatographic Separation, 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/JHG

## Overview

- **Product Code:** JHG
- **Device Name:** Chromatographic Separation, 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K061549](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K061549.md) | AMNIOSTAT-FLM-PG | Irvine Scientific Sales Co., Inc. | Oct 18, 2006 | SESE |
| [K871593](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K871593.md) | TDXR FETAL LUNG MATURITY | Abbott Laboratories | Jul 20, 1987 | SESE |
| [K834616](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K834616.md) | AMNIO STAT-FLM AGGLUTINATION TEST | Hana Biologics, Inc. | May 25, 1984 | SESE |
| [K822150](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K822150.md) | AMNISTAT-FLM | Hana Biologics, Inc. | Oct 21, 1982 | SESE |
| [K813216](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K813216.md) | SECURE FDI TEST KIT | Beckman Instruments, Inc. | Dec 17, 1981 | SESE |
| [K811588](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K811588.md) | HELENA FETAL-TEK 200 METHOD | Helena Laboratories | Jun 25, 1981 | SESE |
| [K790798](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K790798.md) | FETAL MATURITY TEST PROCEDURE | Helena Laboratories | Jun 5, 1979 | SESE |

## Top Applicants

- Hana Biologics, Inc. — 2 clearances
- Helena Laboratories — 2 clearances
- Abbott Laboratories — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- Irvine Scientific Sales Co., Inc. — 1 clearance

---

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

**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