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.
Cleared Devices (118)
| 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 |
| K923503 | URIC ACID ENZYMATIC COLORIMERIC KIT | Randox Laboratories, Ltd. | Jul 22, 1993 | SESE |
| K925113 | OLYMPUS URIC ACID REAGENT | Olympus Corp. | Jan 26, 1993 | SESE |
| K924129 | MILES AUTO METH DETERMIN OF URIC ACID IN URINE | Heraeus Kulzer, Inc. | Sep 22, 1992 | SESE |
| K923414 | SYNERMED 600 NM URIC ACID REAGENT KIT | Synermed, Inc. | Sep 22, 1992 | SESE |
| K922756 | OLYMPUS URIC ACID REAGENT | Olympus Corp. | Jul 17, 1992 | SESE |
| K922762 | ROCHE REAGENT FOR URIC ACID--MODIFICATION | Roche Diagnostic Systems, Inc. | Jul 9, 1992 | SESE |
| K914158 | URIC ACID REAGENT SET | Tech Intl. Co. | Feb 21, 1992 | SESE |
| K912028 | URIC ACID (URICASE) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | Dec 18, 1991 | SESE |
| K913706 | ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 | Em Diagnostic Systems, Inc. | Sep 27, 1991 | SESE |
| K903727 | SYNERMED URIC ACID REAGENT KIT | Synermed, Inc. | Sep 27, 1990 | SESE |
| K896225 | COBAS READY PROFILE 2 REAGENT STRIP | Roche Diagnostic Systems, Inc. | Jun 26, 1990 | SESE |
| K901001 | URIC ACID TEST KIT | Elite Technology, Inc. | May 23, 1990 | SESE |
| K901544 | WAKO(TM) AUTOKIT URIC ACID | Wako Chemicals USA, Inc. | May 14, 1990 | SESE |
| K901693 | TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC | Technicon Instruments Corp. | Apr 25, 1990 | SESE |
| K897161 | COULTER URIC ACID REAGENT | Coulter Electronics, Inc. | Mar 1, 1990 | SESE |
| K896954 | ABBOTT SPECTRUM URIC ACID REAGENT KIT | Abbott Laboratories | Feb 23, 1990 | SESE |
| K896521 | MODIFIED PARAMAX URIC ACID REAGENT | Baxter Healthcare Corp | Feb 16, 1990 | SESE |
| K896227 | COBAS READY URIC ACID REAGENT | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS | Catachem, Inc. | Dec 5, 1989 | SESE |
| K895665 | URIC ACID PAP | Boehringer Mannheim Corp. | Oct 23, 1989 | SESE |
| K894101 | ROCHE REAGENT FOR URIC ACID | Roche Diagnostic Systems, Inc. | Sep 5, 1989 | SESE |
| K894287 | URIC ACID TEST ITEM NUMBER 65422 | Em Diagnostic Systems, Inc. | Aug 28, 1989 | SESE |
| K893416 | URIC ACID REAGENT (PROCEDURE NUMBER 686) | Sigma Chemical Co. | Jun 23, 1989 | SESE |
| K892395 | AMRESCO URIC ACID REAGENTS #7628 | American Research Products Co. | May 24, 1989 | SESE |
| K890319 | URIC ACID KIT, CODES 4825400 AND 4825050 | American Research Products Co. | Apr 12, 1989 | SESE |
| K884704 | URIC ACID TEST (URIC) ITEM #65620 | Em Diagnostic Systems, Inc. | Jan 23, 1989 | SESE |
| K883428 | BIOTROL URIC ACID ENZYMATIQUE TRINDER | Biotrol, USA, Inc. | Sep 13, 1988 | SESE |
| K883404 | URIC ACID REAGENT (PRODUCT #88219) | Hichem Diagnostics | Sep 13, 1988 | SESE |
| K880277 | URIC ACID REAGENT SET | Tech-Neal Scientific, Inc. | Apr 18, 1988 | SESE |
| K880731 | WAKO AUTOKIT URIC ACID | Wako Chemicals USA, Inc. | Mar 24, 1988 | SESE |
| K873456 | PARAMAX URIC ACID REAGENT | Baxter Healthcare Corp | Nov 23, 1987 | SESE |
| K873363 | URIC ACID PAP | Boehringer Mannheim Corp. | Oct 19, 1987 | SESE |
| K871892 | TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER | Technicon Instruments Corp. | Jun 17, 1987 | SESE |
| K871902 | THE URIC ACID REAGENT SET | Macomb Biotechnology, Inc. | Jun 3, 1987 | SESE |
| K871417 | COLORIMETRIC URIC ACID REAGENT SET | Biochemical Trade, Inc. | Apr 22, 1987 | SESE |
| K870868 | EASY-TEST URIC ACID (URIC) #16606 | Em Diagnostic Systems, Inc. | Mar 19, 1987 | SESE |
| K870632 | FAST URIC ACID | Sclavo, Inc. | Mar 13, 1987 | SESE |
| K864341 | IQ URIC ACID TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 16, 1986 | SESE |
| K863924 | URIC ACID | Tech-Co, Inc. | Nov 24, 1986 | SESE |
| K864119 | URIC ACID TEST | U. S. Diagnostics, Inc. | Oct 29, 1986 | SESE |
| K863251 | URIC ACID PROCEDURE | Data Medical Associates, Inc. | Sep 26, 1986 | SESE |
| K863113 | URICMETER | J. D. Assoc. | Sep 9, 1986 | SESE |
| K861831 | REFLOTRON URIC ACID | Boehringer Mannheim Corp. | Jul 11, 1986 | SESE |
| K862208 | KING DIAGNOSTICS URIC ACID TEST | King Diagnostics, Inc. | Jul 8, 1986 | SESE |
| K861660 | URIC ACID PROCEDURE | Data Medical Associates, Inc. | Jun 13, 1986 | SESE |
| K860732 | ENZYMATIC URIC ACID REAGENT | Trace Scientific , Ltd. | Apr 16, 1986 | SESE |
| K860916 | EASY-TEST URIC ACID (URIC), #67516/93 | Em Diagnostic Systems, Inc. | Apr 7, 1986 | SESE |
| K860477 | URIC ACID REAGNET SET (TRINDER) | Sterling Diagnostics, Inc. | Apr 3, 1986 | SESE |
| K854185 | IN-VITRO TEST DETERMINATION OF URIC ACID | Clinical Data, Inc. | Nov 25, 1985 | SESE |
| K853825 | URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS | Catachem, Inc. | Sep 30, 1985 | SESE |
| K853357 | URIC ACID REAGENT | Sigma Diagnostics, Inc. | Aug 19, 1985 | SESE |
| K852004 | UA(URICASE) REAGENT | Alpkem Corp. | May 29, 1985 | SESE |
| K851991 | UN(UREASE)REAGENT UN(A-KETO)REAGENT | Alpkem Corp. | May 29, 1985 | SESE |
| K844011 | FOCUS URIC ACID | Abbott Laboratories | Oct 30, 1984 | SESE |
| K843938 | LINEAR ENZYMATIC URIC ACID SYSTEM | Simmler, Inc. | Oct 30, 1984 | SESE |
| K843325 | SYSTEMATE URIC ACID, HEM 67220 | Em Diagnostic Systems, Inc. | Sep 13, 1984 | SESE |
| K842442 | AXIOM STABLE II URIC ACID TEST | Axiom, Inc. | Aug 16, 1984 | SESE |
| K842103 | TOYO JOZO URIC ACID TEST | Advocacy International, Ltd. | Aug 12, 1984 | SESE |
| K842246 | URIC ACID ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Jul 18, 1984 | SESE |
| K841702 | TDX REA URIC ACID | Abbott Laboratories | May 31, 1984 | SESE |
| K841049 | URIC ACID REAGENT SET ENZYMATIC | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K840781 | URIC ACID REAGENT | American Dade | Apr 13, 1984 | SESE |
| K834045 | URIC ACID REAGENT SET | Sterling Biochemical, Inc. | Jan 30, 1984 | SESE |
| K832785 | COMPUR* EASY TOUCH URIC ACID REAGENT | Worthington Diagnostic Systems | Oct 14, 1983 | SESE |
| K831983 | DATA-ZYME URIC ACID PROCEDURE | Data Medical Associates, Inc. | Aug 8, 1983 | SESE |
| K831864 | URIC-ACID TEST ENZYMATIC COLORIMETRIC | Stanbio Laboratory | Jul 22, 1983 | SESE |
| K831398 | LINEAR ENZMATIC URIC ACID SYSTEM | Simmler, Inc. | Jun 8, 1983 | SESE |
| K830679 | URIC ACID COLORIMETRIC DETERMINATION | Dow Instruments & Reagents, Inc. | Apr 6, 1983 | SESE |
| K823846 | URIC ACID TEST | Scalavo, Inc. | Jan 24, 1983 | SESE |
| K822913 | URIC ACID REAGENT | Ac Biochemical Laboratories, Inc. | Dec 20, 1982 | SESE |
| K821812 | BECKMAN URIC ACID REAGENT | Beckman Instruments, Inc. | Jul 2, 1982 | SESE |
| K821741 | URICACID | Biodynamics Corp. | Jul 2, 1982 | SESE |
| K821214 | URIC ACID REAGENT SET(ENZYMATIC | Omega Medical Electronics | May 21, 1982 | SESE |
| K820632 | COLORIMETRIC URIC ACID REAGENT SET | Biorent Diagnostic, Inc. | Mar 25, 1982 | SESE |
| K813511 | URIC-ACID | Medical Analysis Systems, Inc. | Dec 31, 1981 | SESE |
| K812978 | URIC ACID SYSTEM PACK TEST | Boehringer Mannheim Corp. | Nov 6, 1981 | SESE |
| K812700 | URICAR | Hi Chem, Inc. | Nov 5, 1981 | SESE |
| K812641 | URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM | Reagents Applications, Inc. | Oct 2, 1981 | SESE |
| K812430 | URIC ACID REAGENT SET | Pointe Scientific, Inc., | Sep 9, 1981 | SESE |
| K811810 | URIC ACID TEST | Environmental Chemical Specialties | Jul 15, 1981 | SESE |
| K811857 | SELECT-A-FLOW | Wenmar Intl. Corp. | Jul 10, 1981 | SESE |
| K811687 | URIC ACID TEST | King Diagnostics, Inc. | Jul 1, 1981 | SESE |
| K811504 | WAKO URIC ACID B TEST | Wako Chemicals USA, Inc. | Jun 9, 1981 | SESE |
| K810136 | URIC ACID REAGENT SYSTEM | American Monitor Corp. | Feb 2, 1981 | SESE |
| K802724 | AMES SERA-PAK URIC ACID REAGENT KIT | Miles Laboratories, Inc. | Dec 10, 1980 | SESE |
| K802692 | LANCER URIC ACID AUTO/STAT KIT | Sherwood Medical Co. | Dec 10, 1980 | SESE |
| K801898 | URIC ACID DIAGNOSTIC REAGENT | Connecticut Diagnostics, Ltd. | Oct 10, 1980 | SESE |
| K801649 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | Aug 20, 1980 | SESE |
| K800848 | SERALYZER URIC ACID REAGENT STRIPS - | Miles Laboratories, Inc. | Apr 24, 1980 | SESE |
| K792545 | URIC ACID KIT | Alta Diagnostics, Inc. | Jan 29, 1980 | SESE |
| K791754 | URIC ACID REAGENT | Gilford Diagnostics | Sep 27, 1979 | SESE |
| K791197 | URIDROP SPECIAL | Ab Medett Produkter | Jul 30, 1979 | SESE |
| K790486 | FLOZYME* URIC ACID REAGENT | Worthington Diagnostic Systems | Apr 23, 1979 | SESE |
| K790092 | URIC ACID, BOUND ENZYME | Technicon Instruments Corp. | Mar 12, 1979 | SESE |
| K781004 | HMA URIC ACID TEST | Hycel, Inc. | Jul 27, 1978 | SESE |
| K780827 | URIC ACID RAPID STAT KIT | Pierce Chemical Co. | Jun 13, 1978 | SESE |
| K771088 | UNIPAK URIC ACID | Harleco | Jul 21, 1977 | SESE |
| K770272 | URIC ACID TEST, BMC AUTOFLO | Boehringer Mannheim Corp. | Mar 1, 1977 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 6 clearances
- Boehringer Mannheim Corp. — 5 clearances
- Wako Chemicals USA, Inc. — 4 clearances
- Roche Diagnostic Systems, Inc. — 4 clearances
- Abbott Laboratories — 4 clearances
