JHF · Colorimetric Method, Lecithin/Sphingomyelin Ratio
Clinical Chemistry · 21 CFR 862.1455 · Class 2
Overview
| Product Code | JHF |
|---|---|
| Device Name | Colorimetric Method, Lecithin/Sphingomyelin Ratio |
| Regulation | 21 CFR 862.1455 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 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 | TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II | Abbott Laboratories | Feb 8, 1995 | SESE |
| K883411 | PG-NUMERIC(TM) | Isolab, Inc. | Mar 15, 1989 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- Isolab, Inc. — 1 clearance
