CDH · Acid, Uric, Phosphotungstate Reduction
Clinical Chemistry · 21 CFR 862.1775 · Class 1
Overview
| Product Code | CDH |
|---|---|
| Device Name | Acid, Uric, Phosphotungstate Reduction |
| 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.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K850933 | URIC ACID | Dilab, Inc. | Jun 25, 1985 | SESE |
| K841067 | URIC ACID REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K821213 | URIC ACID REAGENT SET | Omega Medical Electronics | Jul 13, 1982 | SESE |
| K813076 | PHOSPHOTUNGSTATE REDUCTION, URIC ACID | American Monitor Corp. | Nov 16, 1981 | SESE |
| K810088 | URIC ACID (TPTZ) COLORINMETRIC | Bio-Analytics Laboratories, Inc. | Jan 28, 1981 | SESE |
| K800672 | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC | Diagnostic Solutions, Inc. | May 28, 1980 | SESE |
| K800190 | STANBIO DIRECT URIC ACID TEST SET #0770 | Stanbio Laboratory | Feb 13, 1980 | SESE |
| K792412 | ELVI URIC ACID | Volu Sol Medical Industries | Dec 7, 1979 | SESE |
| K792403 | ELVI URIC ACID-COLORIMETRIC METHOD | Volu Sol Medical Industries | Dec 7, 1979 | SESE |
| K790019 | SERUM, URIC ACID DETERMINATION | Fisher Scientific Co., LLC | Feb 26, 1979 | SESE |
| K772082 | ENZAC URIC ACID 100-TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 28, 1977 | SESE |
| K771842 | URIC ACID | Gamma Enterprises, Inc. | Oct 25, 1977 | SESE |
| K770564 | URIC ACID TEST KIT | Mallinckrodt Critical Care | Jun 3, 1977 | SESE |
| K770459 | URIC ACID PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | Apr 29, 1977 | SESE |
| K760477 | REAGENTS-4 FOR URIC ACID DETERMINATION | Simmler & Son, Inc. | Oct 29, 1976 | SESE |
Top Applicants
- Volu Sol Medical Industries — 2 clearances
- American Monitor Corp. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Bio-Analytics Laboratories, Inc. — 1 clearance
- Diagnostic Solutions, Inc. — 1 clearance
