JHC · Acid, Uric, Uricase (Oxygen Rate)
Clinical Chemistry · 21 CFR 862.1775 · Class 1
Overview
| Product Code | JHC |
|---|---|
| Device Name | Acid, Uric, Uricase (Oxygen Rate) |
| Regulation | 21 CFR 862.1775 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863287 | URIC ACID (URICASE) METHOD-II | Catachem, Inc. | Sep 29, 1986 | SESE |
Top Applicants
- Catachem, Inc. — 1 clearance
