{"data":{"id":"us/21-cfr-862.1285","jurisdiction":"us","citation":"21 CFR 862.1285","heading":"Etiocholanolone test system.","body":"(a) Identification. An etiocholanolone test system is a device intended to measure etiocholanolone in serum and urine. Etiocholanolone is a metabolic product of the hormone testosterone and is excreted in the urine. Etiocholanolone measurements are used in the diagnosis and treatment of disorders of the testes and 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":"b25dc003f393c5374764774a96c6d1d434a004ffb87fd83f7a7eab74bd3f8362","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1280","next":"us/21-cfr-862.1290"},"notice":"GroundRules: Original legal text. Not legal advice."}