Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
/ Subpart B - Clinical Chemistry Test Systems / § 862.1509 Methylmalonic acid (nonquantitative) test system.
§ 862.1509 Methylmalonic acid (nonquantitative) test system.
(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.
(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.