JHG · Chromatographic Separation, Lecithin/Sphingomyelin Ratio
Clinical Chemistry · 21 CFR 862.1455 · Class 2
Overview
| Product Code | JHG |
|---|---|
| Device Name | Chromatographic Separation, 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.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K061549 | AMNIOSTAT-FLM-PG | Irvine Scientific Sales Co., Inc. | Oct 18, 2006 | SESE |
| K871593 | TDXR FETAL LUNG MATURITY | Abbott Laboratories | Jul 20, 1987 | SESE |
| K834616 | AMNIO STAT-FLM AGGLUTINATION TEST | Hana Biologics, Inc. | May 25, 1984 | SESE |
| K822150 | AMNISTAT-FLM | Hana Biologics, Inc. | Oct 21, 1982 | SESE |
| K813216 | SECURE FDI TEST KIT | Beckman Instruments, Inc. | Dec 17, 1981 | SESE |
| K811588 | HELENA FETAL-TEK 200 METHOD | Helena Laboratories | Jun 25, 1981 | SESE |
| K790798 | FETAL MATURITY TEST PROCEDURE | Helena Laboratories | Jun 5, 1979 | SESE |
Top Applicants
- Helena Laboratories — 2 clearances
- Hana Biologics, Inc. — 2 clearances
- Irvine Scientific Sales Co., Inc. — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- Abbott Laboratories — 1 clearance
