KNK · Acid, Uric, Uricase (Colorimetric)
Clinical Chemistry · 21 CFR 862.1775 · Class 1
Overview
| Product Code | KNK |
|---|---|
| Device Name | Acid, Uric, Uricase (Colorimetric) |
| 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 (20 of 118)
Showing 20 most recent of 118 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K102568 | URIC ACID MODEL 3P39 | Abbott Laboratories | May 6, 2011 | SESE |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | Olympus America, Inc. | Apr 6, 2007 | SESE |
| K040467 | VITALAB URIC ACID REAGENT | Clinical Data, Inc. | Mar 8, 2004 | SESE |
| K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | Clinical Data, Inc. | Jul 15, 2003 | SESE |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | Mar 18, 2003 | SESE |
| K023550 | WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA | Wiener Laboratories Saic | Dec 9, 2002 | SESE |
| K012038 | JAS URIC ACID LIQUID REAGENT | Jas Diagnostics, Inc. | Aug 21, 2001 | SESE |
| K010421 | WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 | Wiener Laboratories Saic | Apr 13, 2001 | SESE |
| K993469 | WAKO L-TYPE UA F TEST | Wako Chemicals USA, Inc. | Nov 9, 1999 | SESE |
| K991247 | URIC ACID, MODEL UA112-01 | A.P. Total Care, Inc. | May 25, 1999 | SESE |
| K981604 | CARESIDE URIC ACID | Careside, Inc. | Jun 25, 1998 | SESE |
| K970919 | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT | Beckman Instruments, Inc. | May 21, 1997 | SESE |
| K970867 | URIC ACID REAGENT | Derma Media Lab., Inc. | Apr 21, 1997 | SESE |
| K971133 | URIC, UA, OR URIC ACID | Carolina Liquid Chemistries Corp. | Apr 14, 1997 | SESE |
| K970560 | URIC ACID (LIQUID) REAGENT SET | Pointe Scientific, Inc., | Mar 11, 1997 | SESE |
| K961586 | URIC ACID-SL ASSAY CATALOGUE NO. 237-60 | Diagnostic Chemicals , Ltd. | Jul 23, 1996 | SESE |
| K955496 | URIC ACID CATALOGE# 220-93/94/97 | Diagnostic Chemicals , Ltd. | Feb 23, 1996 | SESE |
| K943002 | URIC ACID QVET | Prisma Systems | Dec 2, 1994 | SESE |
| K932728 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) | Eastman Kodak Company | Apr 25, 1994 | SESE |
| K931350 | IL TEST URIC ACID | Instrumentation Laboratory CO | Oct 1, 1993 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 6 clearances
- Boehringer Mannheim Corp. — 5 clearances
- Abbott Laboratories — 4 clearances
- Roche Diagnostic Systems, Inc. — 4 clearances
- Wako Chemicals USA, Inc. — 4 clearances
