21 CFR § 862.1455 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(a) 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.

(b) Classification. Class II.

← § 862.1450 Lactic acid test system.§ 862.1460 Leucine aminopeptidase test system. →