{"data":{"id":"us/21-cfr-862.1470","jurisdiction":"us","citation":"21 CFR 862.1470","heading":"Lipid (total) test system.","body":"(a) Identification. A lipid (total) test system is a device intended to measure total lipids (fats or fat-like substances) in serum and plasma. Lipid (total) measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis.\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 the limitations in § 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":"11f68c9a010c9612f78c4d558c0a3fa736df3a57b6b18417f89ef55b8a85fd62","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1465","next":"us/21-cfr-862.1475"},"notice":"GroundRules: Original legal text. Not legal advice."}