{"data":{"id":"us/21-cfr-862.1455","jurisdiction":"us","citation":"21 CFR 862.1455","heading":"Lecithin/sphingomyelin ratio in amniotic fluid test system.","body":"(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.\n(b) Classification. Class II.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES","Subpart B—Clinical Chemistry Test Systems"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"e77ca3c9423ca1d0c654a5b6d7f036645011a17fb1918bce47c999206ef13943","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1450","next":"us/21-cfr-862.1460"},"notice":"GroundRules: Original legal text. Not legal advice."}