21 CFR 862.1455 — Colorimetric Method, Lecithin/Sphingomyelin Ratio
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1455
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JHF | Colorimetric Method, Lecithin/Sphingomyelin Ratio | 2 | 2 | 3rd Party |
| JHG | Chromatographic Separation, Lecithin/Sphingomyelin Ratio | 2 | 7 | 3rd Party |
| JHH | Electrophoretic Method, Lecithin/Sphingomyelin Ratio | 2 | 0 | 3rd Party |
