{"data":{"id":"us/21-cfr-862.2500","jurisdiction":"us","citation":"21 CFR 862.2500","heading":"Enzyme analyzer for clinical use.","body":"(a) Identification. An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related 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 C—Clinical Laboratory Instruments"],"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":"4b95dc59fde81c4a079acacdd960b7b4fddfac136ee90706b4f19b944a985ce7","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.2485","next":"us/21-cfr-862.2540"},"notice":"GroundRules: Original legal text. Not legal advice."}