Acid, Uric, Uricase (Colorimetric)
FDA product code KNK · Class I (low risk) · 21 CFR 862.1775 · Clinical Chemistry
118510(k) clearances
0PMA approvals
15recalls
Manufacturers
- Em Diagnostic Systems, Inc. 6
- Boehringer Mannheim Corp. 5
- Roche Diagnostic Systems, Inc. 4
- Abbott Laboratories 4
- Wako Chemicals USA, Inc. 4
- Technicon Instruments Corp. 3
- Clinical Data, Inc. 3
- Data Medical Associates, Inc. 3
- Eastman Kodak Company 2
- Beckman Instruments, Inc. 2
- Simmler, Inc. 2
- Pointe Scientific, Inc., 2
- Catachem, Inc. 2
- King Diagnostics, Inc. 2
- Baxter Healthcare Corp 2
- Synermed, Inc. 2
- Miles Laboratories, Inc. 2
- American Research Products Co. 2
- Worthington Diagnostic Systems 2
- Alpkem Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102568 | Uric Acid Model 3P39KNK · Traditional | Abbott Laboratories | 05/06/2011SE |
| K062862 | Olympus Uric Acid Reagent, Model OSR6X98KNK · Traditional | Olympus America, Inc. | 04/06/2007SE |
| K040467 | Vitalab Uric Acid ReagentKNK · Traditional | Clinical Data, Inc. | 03/08/2004SE |
| K031044 | Atac Pak Uric Acid Reagent and Atac CalibratorKNK · Traditional | Clinical Data, Inc. | 07/15/2003SE |
| K022096 | Uric Acid Assay for the Advia Integrated Modular SystemKNK · Traditional | Bayer Diagnostics Corp. | 03/18/2003SE |
| K023550 | Wiener Lab Uricostat Enzimatico Aa LiquidaKNK · Traditional | Wiener Laboratories Saic | 12/09/2002SE |
| K012038 | Jas Uric Acid Liquid ReagentKNK · Traditional | Jas Diagnostics, Inc. | 08/21/2001SE |
| K010421 | Wiener Lab. Uricostat Enzimatico Aa, Models 2X50 ML Catalogue No 1840106 and 4X50 ML…KNK · Traditional | Wiener Laboratories Saic | 04/13/2001SE |
| K993469 | Wako L-Type Ua F TestKNK · Traditional | Wako Chemicals USA, Inc. | 11/09/1999SE |
| K991247 | Uric Acid, Model UA112-01KNK · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K981604 | Careside Uric AcidKNK · Traditional | Careside, Inc. | 06/25/1998SE |
| K970919 | Synchron CX Systems Uric Acid (Uric) ReagentKNK · Traditional | Beckman Instruments, Inc. | 05/21/1997SE |
| K970867 | Uric Acid ReagentKNK · Traditional | Derma Media Lab., Inc. | 04/21/1997SE |
| K971133 | Uric, Ua, or Uric AcidKNK · Traditional | Carolina Liquid Chemistries Corp. | 04/14/1997SE |
| K970560 | Uric Acid (Liquid) Reagent SetKNK · Traditional | Pointe Scientific, Inc., | 03/11/1997SE |
| K961586 | Uric Acid-Sl Assay Catalogue No. 237-60KNK · Traditional | Diagnostic Chemicals , Ltd. | 07/23/1996SE |
| K955496 | Uric Acid Cataloge# 220-93/94/97KNK · Traditional | Diagnostic Chemicals , Ltd. | 02/23/1996SE |
| K943002 | Uric Acid QvetKNK · Traditional | Prisma Systems | 12/02/1994SE |
| K932728 | Kodak Ektachem Clinical Chemistry Slides (Uric)KNK · Traditional | Eastman Kodak Company | 04/25/1994SE |
| K931350 | Il Test Uric AcidKNK · Traditional | Instrumentation Laboratory CO | 10/01/1993SE |
| K923503 | Uric Acid Enzymatic Colorimeric KitKNK · Traditional | Randox Laboratories, Ltd. | 07/22/1993SE |
| K925113 | Olympus Uric Acid ReagentKNK · Traditional | Olympus Corp. | 01/26/1993SE |
| K924129 | Miles Auto Meth Determin of Uric Acid in UrineKNK · Traditional | Heraeus Kulzer, Inc. | 09/22/1992SE |
| K923414 | Synermed 600 NM Uric Acid Reagent KitKNK · Traditional | Synermed, Inc. | 09/22/1992SE |
| K922756 | Olympus Uric Acid ReagentKNK · Traditional | Olympus Corp. | 07/17/1992SE |
| K922762 | Roche Reagent for Uric Acid--ModificationKNK · Traditional | Roche Diagnostic Systems, Inc. | 07/09/1992SE |
| K914158 | Uric Acid Reagent SetKNK · Traditional | Tech Intl. Co. | 02/21/1992SE |
| K912028 | Uric Acid (Uricase) Reagent, UniversalKNK · Traditional | Enzyme Technology, Inc. | 12/18/1991SE |
| K913706 | Abbott Quickstart Uric Acid Test (Urca) Item# 5A34KNK · Traditional | Em Diagnostic Systems, Inc. | 09/27/1991SE |
| K903727 | Synermed Uric Acid Reagent KitKNK · Traditional | Synermed, Inc. | 09/27/1990SE |
| K896225 | Cobas Ready Profile 2 Reagent StripKNK · Traditional | Roche Diagnostic Systems, Inc. | 06/26/1990SE |
| K901001 | Uric Acid Test KitKNK · Traditional | Elite Technology, Inc. | 05/23/1990SE |
| K901544 | Wako(Tm) Autokit Uric AcidKNK · Traditional | Wako Chemicals USA, Inc. | 05/14/1990SE |
| K901693 | Technicon Chem 1 Clinical Analyzer for Urine UricKNK · Traditional | Technicon Instruments Corp. | 04/25/1990SE |
| K897161 | Coulter Uric Acid ReagentKNK · Traditional | Coulter Electronics, Inc. | 03/01/1990SE |
| K896954 | Abbott Spectrum Uric Acid Reagent KitKNK · Traditional | Abbott Laboratories | 02/23/1990SE |
| K896521 | Modified Paramax Uric Acid ReagentKNK · Traditional | Baxter Healthcare Corp | 02/16/1990SE |
| K896227 | Cobas Ready Uric Acid ReagentKNK · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K895821 | Uric Acid for Manual/Automated ApplicationsKNK · Traditional | Catachem, Inc. | 12/05/1989SE |
| K895665 | Uric Acid PapKNK · Traditional | Boehringer Mannheim Corp. | 10/23/1989SE |
| K894101 | Roche Reagent for Uric AcidKNK · Traditional | Roche Diagnostic Systems, Inc. | 09/05/1989SE |
| K894287 | Uric Acid Test Item Number 65422KNK · Traditional | Em Diagnostic Systems, Inc. | 08/28/1989SE |
| K893416 | Uric Acid Reagent (Procedure Number 686)KNK · Traditional | Sigma Chemical Co. | 06/23/1989SE |
| K892395 | Amresco Uric Acid Reagents #7628KNK · Traditional | American Research Products Co. | 05/24/1989SE |
| K890319 | Uric Acid Kit, Codes 4825400 and 4825050KNK · Traditional | American Research Products Co. | 04/12/1989SE |
| K884704 | Uric Acid Test (Uric) Item #65620KNK · Traditional | Em Diagnostic Systems, Inc. | 01/23/1989SE |
| K883428 | Biotrol Uric Acid Enzymatique TrinderKNK · Traditional | Biotrol, USA, Inc. | 09/13/1988SE |
| K883404 | Uric Acid Reagent (Product #88219)KNK · Traditional | Hichem Diagnostics | 09/13/1988SE |
| K880277 | Uric Acid Reagent SetKNK · Traditional | Tech-Neal Scientific, Inc. | 04/18/1988SE |
| K880731 | Wako Autokit Uric AcidKNK · Traditional | Wako Chemicals USA, Inc. | 03/24/1988SE |
| K873456 | Paramax Uric Acid ReagentKNK · Traditional | Baxter Healthcare Corp | 11/23/1987SE |
| K873363 | Uric Acid PapKNK · Traditional | Boehringer Mannheim Corp. | 10/19/1987SE |
| K871892 | Technicon Ra(R) Systems & Assist(R) Clin. AnalyzerKNK · Traditional | Technicon Instruments Corp. | 06/17/1987SE |
| K871902 | The Uric Acid Reagent SetKNK · Traditional | Macomb Biotechnology, Inc. | 06/03/1987SE |
| K871417 | Colorimetric Uric Acid Reagent SetKNK · Traditional | Biochemical Trade, Inc. | 04/22/1987SE |
| K870868 | Easy-Test Uric Acid (Uric) #16606KNK · Traditional | Em Diagnostic Systems, Inc. | 03/19/1987SE |
| K870632 | Fast Uric AcidKNK · Traditional | Sclavo, Inc. | 03/13/1987SE |
| K864341 | Iq Uric Acid TestKNK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/16/1986SE |
| K863924 | Uric AcidKNK · Traditional | Tech-Co, Inc. | 11/24/1986SE |
| K864119 | Uric Acid TestKNK · Traditional | U. S. Diagnostics, Inc. | 10/29/1986SE |
| K863251 | Uric Acid ProcedureKNK · Traditional | Data Medical Associates, Inc. | 09/26/1986SE |
| K863113 | UricmeterKNK · Traditional | J. D. Assoc. | 09/09/1986SE |
| K861831 | Reflotron Uric AcidKNK · Traditional | Boehringer Mannheim Corp. | 07/11/1986SE |
| K862208 | King Diagnostics Uric Acid TestKNK · Traditional | King Diagnostics, Inc. | 07/08/1986SE |
| K861660 | Uric Acid ProcedureKNK · Traditional | Data Medical Associates, Inc. | 06/13/1986SE |
| K860732 | Enzymatic Uric Acid ReagentKNK · Traditional | Trace Scientific , Ltd. | 04/16/1986SE |
| K860916 | Easy-Test Uric Acid (Uric), #67516/93KNK · Traditional | Em Diagnostic Systems, Inc. | 04/07/1986SE |
| K860477 | Uric Acid Reagnet Set (Trinder)KNK · Traditional | Sterling Diagnostics, Inc. | 04/03/1986SE |
| K854185 | In-Vitro Test Determination of Uric AcidKNK · Traditional | Clinical Data, Inc. | 11/25/1985SE |
| K853825 | Uric Acid(Uricase) for Continuous Flow InstrumentsKNK · Traditional | Catachem, Inc. | 09/30/1985SE |
| K853357 | Uric Acid ReagentKNK · Traditional | Sigma Diagnostics, Inc. | 08/19/1985SE |
| K852004 | Ua(Uricase) ReagentKNK · Traditional | Alpkem Corp. | 05/29/1985SE |
| K851991 | Un(Urease)Reagent Un(A-Keto)ReagentKNK · Traditional | Alpkem Corp. | 05/29/1985SE |
| K844011 | Focus Uric AcidKNK · Traditional | Abbott Laboratories | 10/30/1984SE |
| K843938 | Linear Enzymatic Uric Acid SystemKNK · Traditional | Simmler, Inc. | 10/30/1984SE |
| K843325 | Systemate Uric Acid, Hem 67220KNK · Traditional | Em Diagnostic Systems, Inc. | 09/13/1984SE |
| K842442 | Axiom Stable II Uric Acid TestKNK · Traditional | Axiom, Inc. | 08/16/1984SE |
| K842103 | Toyo Jozo Uric Acid TestKNK · Traditional | Advocacy International, Ltd. | 08/12/1984SE |
| K842246 | Uric Acid Assay KitKNK · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/18/1984SE |
| K841702 | TDX Rea Uric AcidKNK · Traditional | Abbott Laboratories | 05/31/1984SE |
| K841049 | Uric Acid Reagent Set EnzymaticKNK · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K840781 | Uric Acid ReagentKNK · Traditional | American Dade | 04/13/1984SE |
| K834045 | Uric Acid Reagent SetKNK · Traditional | Sterling Biochemical, Inc. | 01/30/1984SE |
| K832785 | Compur* Easy Touch Uric Acid ReagentKNK · Traditional | Worthington Diagnostic Systems | 10/14/1983SE |
| K831983 | Data-Zyme Uric Acid ProcedureKNK · Traditional | Data Medical Associates, Inc. | 08/08/1983SE |
| K831864 | Uric-Acid Test Enzymatic ColorimetricKNK · Traditional | Stanbio Laboratory | 07/22/1983SE |
| K831398 | Linear Enzmatic Uric Acid SystemKNK · Traditional | Simmler, Inc. | 06/08/1983SE |
| K830679 | Uric Acid Colorimetric DeterminationKNK · Traditional | Dow Instruments & Reagents, Inc. | 04/06/1983SE |
| K823846 | Uric Acid TestKNK · Traditional | Scalavo, Inc. | 01/24/1983SE |
| K822913 | Uric Acid ReagentKNK · Traditional | Ac Biochemical Laboratories, Inc. | 12/20/1982SE |
| K821812 | Beckman Uric Acid ReagentKNK · Traditional | Beckman Instruments, Inc. | 07/02/1982SE |
| K821741 | UricacidKNK · Traditional | Biodynamics Corp. | 07/02/1982SE |
| K821214 | Uric Acid Reagent Set(EnzymaticKNK · Traditional | Omega Medical Electronics | 05/21/1982SE |
| K820632 | Colorimetric Uric Acid Reagent SetKNK · Traditional | Biorent Diagnostic, Inc. | 03/25/1982SE |
| K813511 | Uric-AcidKNK · Traditional | Medical Analysis Systems, Inc. | 12/31/1981SE |
| K812978 | Uric Acid System Pack TestKNK · Traditional | Boehringer Mannheim Corp. | 11/06/1981SE |
| K812700 | UricarKNK · Traditional | Hi Chem, Inc. | 11/05/1981SE |
| K812641 | Uric Acid REAGENT-ENZYMATIC-COLOR-520 NMKNK · Traditional | Reagents Applications, Inc. | 10/02/1981SE |
| K812430 | Uric Acid Reagent SetKNK · Traditional | Pointe Scientific, Inc., | 09/09/1981SE |
| K811810 | Uric Acid TestKNK · Traditional | Environmental Chemical Specialties | 07/15/1981SE |
| K811857 | Select-A-FlowKNK · Traditional | Wenmar Intl. Corp. | 07/10/1981SE |
| K811687 | Uric Acid TestKNK · Traditional | King Diagnostics, Inc. | 07/01/1981SE |
| K811504 | Wako Uric Acid B TestKNK · Traditional | Wako Chemicals USA, Inc. | 06/09/1981SE |
| K810136 | Uric Acid Reagent SystemKNK · Traditional | American Monitor Corp. | 02/02/1981SE |
| K802724 | Ames Sera-Pak Uric Acid Reagent KitKNK · Traditional | Miles Laboratories, Inc. | 12/10/1980SE |
| K802692 | Lancer Uric Acid Auto/Stat KitKNK · Traditional | Sherwood Medical Co. | 12/10/1980SE |
| K801898 | Uric Acid Diagnostic ReagentKNK · Traditional | Connecticut Diagnostics, Ltd. | 10/10/1980SE |
| K801649 | Kodak Ektachem Clinical Chemistry SlidesKNK · Traditional | Eastman Kodak Company | 08/20/1980SE |
| K800848 | Seralyzer Uric Acid Reagent Strips -KNK · Traditional | Miles Laboratories, Inc. | 04/24/1980SE |
| K792545 | Uric Acid KitKNK · Traditional | Alta Diagnostics, Inc. | 01/29/1980SE |
| K791754 | Uric Acid ReagentKNK · Traditional | Gilford Diagnostics | 09/27/1979SE |
| K791197 | Uridrop SpecialKNK · Traditional | Ab Medett Produkter | 07/30/1979SE |
| K790486 | Flozyme* Uric Acid ReagentKNK · Traditional | Worthington Diagnostic Systems | 04/23/1979SE |
| K790092 | Uric Acid, Bound EnzymeKNK · Traditional | Technicon Instruments Corp. | 03/12/1979SE |
| K781004 | Hma Uric Acid TestKNK · Traditional | Hycel, Inc. | 07/27/1978SE |
| K780827 | Uric Acid Rapid Stat KitKNK · Traditional | Pierce Chemical Co. | 06/13/1978SE |
| K771088 | Unipak Uric AcidKNK · Traditional | Harleco | 07/21/1977SE |
| K770272 | Uric Acid Test, BMC AutofloKNK · Traditional | Boehringer Mannheim Corp. | 03/01/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2086-2026 Class II | Uric Acid in vitro diagnostic test REF: 31H0PThe devices were distributed without required FDA premarket clearance or approval. | DFI Co., Ltd. | 04/02/2026Open, Classified |
| Z-1424-2020 Class II | Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only…It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen… | Beckman Coulter Inc | 08/15/2019Terminated |
| Z-0211-2020 Class II | Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at… | Beckman Coulter Inc. | 08/24/2018Terminated |
| Z-2079-2017 Class II | Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative…Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole… | Beckman Coulter Inc. | 04/03/2017Terminated |
| Z-0092-2017 Class II | VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales…Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose… | Ortho-Clinical Diagnostics | 08/11/2016Terminated |
| Z-1932-2016 Class II | Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System…Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the… | Beckman Coulter Inc. | 04/13/2016Terminated |
| Z-1666-2016 Class II | Dimension Vista Assays: Uric Acid (URCA)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | Siemens Healthcare Diagnostics, Inc. | 03/17/2016Terminated |
| Z-1662-2016 Class II | Dimension Assays: Uric Acid (URCA)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | Siemens Healthcare Diagnostics, Inc. | 03/17/2016Terminated |
| Z-1658-2016 Class II | Advia Chemistry Assay: Uric Acid and Uric Acid, concentratedSiemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | Siemens Healthcare Diagnostics, Inc. | 03/17/2016Terminated |
| Z-0743-2016 Class II | ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the…N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with… | Horiba Instruments Inc | 01/11/2016Terminated |
| Z-1931-2015 Class II | Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | Roche Diagnostics Operations, Inc. | 05/07/2015Terminated |
| Z-1024-2015 Class II | Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen… | Beckman Coulter Inc. | 12/15/2014Terminated |
| Z-0328-2014 Class II | VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-0913-2010 | Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton…A process deviation occurred during the production of the R1 component which may affect its performance. | Pointe Scientific, Inc. | 12/01/2009Terminated |
| Z-0912-2010 | Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI…A process deviation occurred during the production of the R1 component which may affect its performance. | Pointe Scientific, Inc. | 12/01/2009Terminated |