21 C.F.R. § 862.1455
Lecithin/sphingomyelin ratio in amniotic fluid test system.
Cite as 21 C.F.R. § 862.1455 (2026)
(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.