Product Code: CDO FDA class 1 21 CFR 862.1775

Acid, Uric, Uricase (U.V.)

Clinical Chemistry

The Uricase (UV) Uric Acid Test is a clinical chemistry device that quantifies uric acid in blood or urine by enzymatic oxidation using uricase, with the reaction measured spectrophotometrically in the ultraviolet range, providing a highly specific method for diagnosing and monitoring gout and hyperuricemia. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CDO, regulated under 21 CFR 862.1775, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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Basic Information

Product Code: CDO
Device Class: FDA class 1
Regulation Number: 862.1775
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K033278	RANDOX URIC ACID	Feb 27, 2004	Substantially Equivalent	Randox Laboratories, Ltd.
K992798	SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P	Sep 28, 1999	Substantially Equivalent	Sigma Diagnostics, Inc.
K982251	SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT	Aug 18, 1998	Substantially Equivalent	Sigma Diagnostics, Inc.
K981766	URIC ACID	Jun 19, 1998	Substantially Equivalent	Abbott Laboratories
K981189	URIC ACID	May 07, 1998	Substantially Equivalent	Abbott Laboratories
K971485	URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)	May 27, 1997	Substantially Equivalent	Trace America, Inc.
K955752	OLYMPUS URIC ACID REAGENT	Jan 31, 1996	Substantially Equivalent	Olympus America, Inc.
K932162	URIC ACID TEST ITEM NUMBER 65422	Sep 27, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923765	SYSTEMATE URICACID TEST, TECHNICON RA 1000	Sep 22, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K903335	SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422	Aug 17, 1990	Substantially Equivalent	Em Diagnostic Systems, Inc.
K875320	BIOTROL URIC ACID ENZYMATIQUE UV H.P.	Feb 01, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K873358	GEMENI URIC ACID U.V.	Sep 11, 1987	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K863660	EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95	Oct 29, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K844986	ROCHE REAGENTS REAGENT FOR URIC ACID	Jan 18, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K822884	URIC ACID 75CDO	Oct 27, 1982	Substantially Equivalent	Technicon Instruments Corp.
K821872	ULTRACHEM URIC ACID AIDH	Jul 14, 1982	Substantially Equivalent	Harleco Diagnostics
K821474	ULTRACHEM URIC ACID AIDH #65047	Jun 03, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821465	ULTRACHEM URIC ACID AIDH, #65047	Jun 02, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821167	URICASE (U.V.) URIC ACID	May 14, 1982	Substantially Equivalent	Syn-Kit, Inc.
K813244	UV URIC ACID DETERMINATION	Dec 08, 1981	Substantially Equivalent	Biorent Diagnostic, Inc.
K812500	ULTRACHEM URIC ACID ALDH, ITEM #65047	Sep 23, 1981	Substantially Equivalent	Harleco
K802371	URIC ACID/ALDH	Oct 23, 1980	Substantially Equivalent	Boehringer Mannheim Corp.
K801243	COBAS REAGENTS FOR URIC ACID	Jun 26, 1980	Substantially Equivalent	Roche Analytical Instruments, Inc.
K800130	CENTRIFICHEM URIC ACID	Feb 13, 1980	Substantially Equivalent	Union Carbide Corp.
K790834	UV URIC ACID DETERMINATION	Jun 28, 1979	Substantially Equivalent	The Dow Chemical Co.
K781996	ACID REAGENT, URIC SINGLE VIAL	Jan 03, 1979	Substantially Equivalent	Calbiochem-Behring Corp.
K780859	PRINCETON BIOMEDIX URICASE (UV)	Jul 27, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K771509	MULTISTAT III URIC ACID TEST	Sep 13, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K770831	STATZYME URIC ACID REAGENT	Jul 11, 1977	Substantially Equivalent	Worthington Biochemical Corp.
K770767	IN VITRO DIAG. FOR URIC ACID	Jul 05, 1977	Substantially Equivalent	Smithkline Diagnostics, Inc.
K760989	URIC ACID REAGENT SET	Dec 09, 1976	Substantially Equivalent	Worthington Biochemical Corp.