{"data":{"id":"us/21-cfr-862.1430","jurisdiction":"us","citation":"21 CFR 862.1430","heading":"17-Ketosteroids test system.","body":"(a) Identification. A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.\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":"2a05f1430bad8cb3b881e6007a02e065cc73672ebc7c49bc9f621ce53ae88fb8","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1420","next":"us/21-cfr-862.1435"},"notice":"GroundRules: Original legal text. Not legal advice."}