{"data":{"id":"us/21-cfr-862.1509","jurisdiction":"us","citation":"21 CFR 862.1509","heading":"Methylmalonic acid (nonquantitative) test system.","body":"(a) Identification. A methylmalonic acid (nonquantitative) test system is a device intended to identify methylmalonic acid in urine. The identification of methylmalonic acid in urine is used in the diagnosis and treatment of methylmalonic aciduria, a heritable metabolic disorder which, if untreated, may cause mental retardation.\n(b) Classification. Class II (special 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":"9b12bdf4c5598a83f5c79e81ded9248ce0cecbf0b6e4b67e5a0e0de1d5c43709","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1506","next":"us/21-cfr-862.1510"},"notice":"GroundRules: Original legal text. Not legal advice."}