{"data":{"id":"us/21-cfr-862.1585","jurisdiction":"us","citation":"21 CFR 862.1585","heading":"Human placental lactogen test system.","body":"(a) Identification. A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also known as human chorionic somatomammotrophin (HCS)), in maternal serum and maternal plasma. Measurements of human placental lactogen are used in the diagnosis and clinical management of high-risk pregnancies involving fetal distress associated with placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post-maturity, placental insufficiency, or possible miscarriage.\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":"c9e5c627076c3bd173c3dbdea0e59a1390c110554d233dbf098719760134db6c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1580","next":"us/21-cfr-862.1590"},"notice":"GroundRules: Original legal text. Not legal advice."}