{"data":{"id":"us/21-cfr-862.1080","jurisdiction":"us","citation":"21 CFR 862.1080","heading":"Androsterone test system.","body":"(a) Identification. An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and adrenal diseases.\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":"b307d83d2d970a6be57582c3b3cdb5a92c543c5e76bcbb30eb3d9486c162efb6","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1075","next":"us/21-cfr-862.1085"},"notice":"GroundRules: Original legal text. Not legal advice."}