CDO · Acid, Uric, Uricase (U.V.)
Clinical Chemistry · 21 CFR 862.1775 · Class 1
Overview
| Product Code | CDO |
|---|---|
| Device Name | Acid, Uric, Uricase (U.V.) |
| 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 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K033278 | RANDOX URIC ACID | Randox Laboratories, Ltd. | Feb 27, 2004 | SESE |
| K992798 | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P | Sigma Diagnostics, Inc. | Sep 28, 1999 | SESE |
| K982251 | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT | Sigma Diagnostics, Inc. | Aug 18, 1998 | SESE |
| K981766 | URIC ACID | Abbott Laboratories | Jun 19, 1998 | SESE |
| K981189 | URIC ACID | Abbott Laboratories | May 7, 1998 | SESE |
| K971485 | URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | May 27, 1997 | SESE |
| K955752 | OLYMPUS URIC ACID REAGENT | Olympus America, Inc. | Jan 31, 1996 | SESE |
| K932162 | URIC ACID TEST ITEM NUMBER 65422 | Em Diagnostic Systems, Inc. | Sep 27, 1993 | SESE |
| K923765 | SYSTEMATE URICACID TEST, TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | Sep 22, 1992 | SESE |
| K903335 | SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 | Em Diagnostic Systems, Inc. | Aug 17, 1990 | SESE |
| K875320 | BIOTROL URIC ACID ENZYMATIQUE UV H.P. | Biotrol, USA, Inc. | Feb 1, 1988 | SESE |
| K873358 | GEMENI URIC ACID U.V. | Electro-Nucleonics Laboratories, Inc. | Sep 11, 1987 | SESE |
| K863660 | EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 | Em Diagnostic Systems, Inc. | Oct 29, 1986 | SESE |
| K844986 | ROCHE REAGENTS REAGENT FOR URIC ACID | Roche Diagnostic Systems, Inc. | Jan 18, 1985 | SESE |
| K822884 | URIC ACID 75CDO | Technicon Instruments Corp. | Oct 27, 1982 | SESE |
| K821872 | ULTRACHEM URIC ACID AIDH | Harleco Diagnostics | Jul 14, 1982 | SESE |
| K821474 | ULTRACHEM URIC ACID AIDH #65047 | Emd Chemicals, Inc. | Jun 3, 1982 | SESE |
| K821465 | ULTRACHEM URIC ACID AIDH, #65047 | Emd Chemicals, Inc. | Jun 2, 1982 | SESE |
| K821167 | URICASE (U.V.) URIC ACID | Syn-Kit, Inc. | May 14, 1982 | SESE |
| K813244 | UV URIC ACID DETERMINATION | Biorent Diagnostic, Inc. | Dec 8, 1981 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 4 clearances
- Abbott Laboratories — 2 clearances
- Emd Chemicals, Inc. — 2 clearances
- Sigma Diagnostics, Inc. — 2 clearances
- Worthington Biochemical Corp. — 2 clearances
