{"data":{"id":"us/21-cfr-862.1385","jurisdiction":"us","citation":"21 CFR 862.1385","heading":"17-Hydroxycorticosteroids (17-ketogenic steroids) test system.","body":"(a) Identification. A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone\nmoiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders.\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":"5266b2cd2c52ec18b008a312788878f5da8a86c27ea8914de6107d76a3201f14","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1380","next":"us/21-cfr-862.1390"},"notice":"GroundRules: Original legal text. Not legal advice."}