{"data":{"id":"us/21-cfr-862.1395","jurisdiction":"us","citation":"21 CFR 862.1395","heading":"17-Hydroxyprogesterone test system.","body":"(a) Identification. A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.","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":"88e9ff9e1fde572f68188f515572df0040e0e66d8ae7afa8d607185b56eea220","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1390","next":"us/21-cfr-862.1400"},"notice":"GroundRules: Original legal text. Not legal advice."}