21 C.F.R. § 862.1509

Current through October 31, 2024
Section 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 .

21 C.F.R. §862.1509

52 FR 16122, May 1, 1987, as amended at 84 FR 71796 , Dec. 30, 2019