{"data":{"id":"us/21-cfr-862.1245","jurisdiction":"us","citation":"21 CFR 862.1245","heading":"Dehydroepiandrosterone (free and sulfate) test system.","body":"(a) Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.\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":"5b4fdeaf6c70b83e1f72588730a04db4c6fbaf19d9ca398d26f3d50cb4ec1ced","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1240","next":"us/21-cfr-862.1250"},"notice":"GroundRules: Original legal text. Not legal advice."}