21 CFR 862.1775 — Acid, Uric, Phosphotungstate Reduction
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1775
Identification
A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Classification Rationale
Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 15 | |
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 31 | |
| JHA | Acid, Uric, Uricase (Gasometric) | 1 | 0 | |
| JHC | Acid, Uric, Uricase (Oxygen Rate) | 1 | 1 | |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 | 118 | |
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | 1 | 5 | |
| PTC | Uric Acid Test System For At Home Prescription Use | 1 | 3 | 3rd Party |
