LPT · System, Test, Urinary Methylmalonic Acid
Clinical Chemistry · 21 CFR 862.1509 · Class 2
Overview
| Product Code | LPT |
|---|---|
| Device Name | System, Test, Urinary Methylmalonic Acid |
| Regulation | 21 CFR 862.1509 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
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.
Special Controls
*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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
