C-Reactive Protein, Antigen, Antiserum, And Control
FDA product code DCK · Class II (moderate risk) · 21 CFR 866.5270 · Immunology
126510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Kamiya Biomedical Co. 9
- E.I. Dupont DE Nemours & Co., Inc. 5
- Syva Co. 5
- Beckman Instruments, Inc. 4
- Beckman Coulter Inc. 4
- Behring Diagnostics, Inc. 3
- Horiba Abx 3
- Boehringer Mannheim Corp. 3
- Abbott Laboratories 3
- Ortho-Clinical Diagnostics 3
- Hemagen Diagnostics, Inc. 3
- Randox Laboratories, Ltd. 3
- Wako Chemicals USA, Inc. 3
- The Binding Site, Ltd. 3
- Diagnostic Products Corp. 2
- Atlantic Antibodies 2
- Crestat Diagnostics, Inc. 2
- Kallestad Laboratories, Inc. 2
- Primus Corp. 2
- Technicon Instruments Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2)DCK · Traditional | Kamiya Biomedical Company, LLC | 04/18/2025SE |
| K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeDCK · Traditional | Procise Diagnostics | 11/04/2022SE |
| K192028 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 06/25/2020SE |
| K192118 | CRP VarioDCK · Special | SENTINEL CH. SpA | 11/08/2019SE |
| K191993 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 10/03/2019SE |
| K160712 | VITROS Chemistry Products hsCRP ReagentDCK · Traditional | Ortho Clinical Diagnostics | 07/14/2017SE |
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…DCK · Traditional | Orion Diagnostica, OY | 03/10/2016SE |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7DCK · Special | Ortho Clinical Diagnostics | 09/24/2015SE |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | Qualigen, Inc. | 01/07/2015SE |
| K121558 | Diazyme Hscrp Poc Test KitDCK · Traditional | Diazyme Laboratories | 09/21/2012SE |
| K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDCK · Traditional | Diazyme Laboratories | 04/27/2011SE |
| K061138 | Abx Pentra 400 : CRPDCK · Traditional | Horiba Abx | 09/29/2006SE |
| K060139 | Crp-Advance Assay, Models 250-20, 250-25DCK · Traditional | Diagnostic Chemicals , Ltd. | 04/28/2006SE |
| K052591 | Nanopia Wide Range C-Reactive Protein (CRP) Reagent KitDCK · Traditional | Clinical Data, Inc. | 02/09/2006SE |
| K050836 | CRP Diagnostic AssayDCK · Traditional | Sentinel Ch. Srl | 08/08/2005SE |
| K041155 | Wide Range C-Reactive Protein (WR CRP) AssayDCK · Traditional | Stanbio Laboratory | 10/14/2004SE |
| K042442 | Quickread System: Quickread CRP Kit, Model 06085; Quickread 101 Instrument, Model 06088…DCK · Special | Orion Diagnostica, OY | 09/24/2004SE |
| K040241 | N-Geneous Wide Range CRP Reagent and Calibrator SetDCK · Traditional | Genzyme Corp. | 06/25/2004SE |
| K040579 | Choletech LDX High-Sensitivity C-Reactive Protein (Hs-Crp)DCK · Traditional | Cholestech Corp. | 06/18/2004SE |
| K032663 | Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls…DCK · Traditional | Instrumentation Laboratory CO | 12/19/2003SE |
| K031607 | Orion Diagnostica Quikread CRP Kit and Quikread CRP ControlDCK · Traditional | Orion Diagnostica, Div. Orion Corp. | 10/10/2003SE |
| K030044 | Extended Range HS CRP Kit, Cat NO:9200DCK · Traditional | Reference Diagnostics, Inc. | 09/30/2003SE |
| K024280 | Wako CRP, Calibrator and Wako CRP Calibrator SetDCK · Traditional | Wako Chemicals USA, Inc. | 06/06/2003SE |
| K030545 | Crp-Latex (II)X2 Seiken Assay KitDCK · Traditional | Denka Seiken Co., Ltd. | 06/02/2003SE |
| K030626 | Vitros Chemistry Products CRP Slide and Calibrator Kit 7DCK · Special | Ortho-Clinical Diagnostics, Inc. | 03/18/2003SE |
| K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…DCK · Traditional | Kamiya Biomedical Co. | 02/04/2003SE |
| K023269 | Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity ControlsDCK · Traditional | Instrumentation Laboratory CO | 12/23/2002SE |
| K022176 | Orion Diagnostica Ultrasensitive CRP Kit, Model 68025, & Orion Diagnostica…DCK · Traditional | Orion Diagnostica, Div. Orion Corp. | 12/03/2002SE |
| K022486 | K-Assay Hs-Crp ControlsDCK · Traditional | Kamiya Biomedical Co. | 08/14/2002SE |
| K021194 | Raichem CRP High Sensitivity Test SystemDCK · Traditional | Hemagen Diagnostics, Inc. | 07/29/2002SE |
| K021609 | Rdi HS CRP KitDCK · Traditional | Reference Diagnostics, Inc. | 06/27/2002SE |
| K013787 | Nycocard CRPDCK · Traditional | Primus Corp. | 05/14/2002SE |
| K014084 | Nycocard CRP ControlDCK · Traditional | Primus Corp. | 01/07/2002SE |
| K003851 | Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model BC-1119DCK · Traditional | Biocheck, Inc. | 07/20/2001SE |
| K010597 | Synchron LX Systems High Sensitivity C-Reactive Protien (CRPH) ReagentDCK · Traditional | Beckman Coulter, Inc. | 05/29/2001SE |
| K011079 | K-Assay Hs-Crp ControlsDCK · Traditional | Kamiya Biomedical Co. | 05/16/2001SE |
| K010236 | Immage Immunochemistry System High Sensitivity C-Reactive Protein (CRPH) ReagentDCK · Traditional | Beckman Coulter, Inc. | 04/05/2001SE |
| K002558 | K-Assay High Sensitive CRP(2) for the Beckman Coulter ImmageDCK · Special | Kamiya Biomedical Co. | 10/25/2000SE |
| K002651 | C-Reactive Protein (High Sensitivity) Reagent SetDCK · Traditional | Pointe Scientific, Inc., | 10/13/2000SE |
| K001636 | C-Reactive Protein Antiserum KitDCK · Traditional | The Binding Site, Ltd. | 08/24/2000SE |
| K001009 | Randox C-Reactive ProteinDCK · Traditional | Randox Laboratories, Ltd. | 08/04/2000SE |
| K991385 | Dade Behring N High Sensitivity CRP AssayDCK · Traditional | Dade Behring, Inc. | 10/25/1999SE |
| K992312 | K-Assay CRP (2), K-Assay CRP Multi-Calibrator a, K-Assay CRP Multi-Calibrator BDCK · Traditional | Kamiya Biomedical Co. | 09/13/1999SE |
| K992311 | K-Assay CRP(1), K-Assay CRP Multi-Calibrator a, K-Assay CRP Multi-CalibratorcDCK · Traditional | Kamiya Biomedical Co. | 09/13/1999SE |
| K991224 | K-Assay CRPDCK · Traditional | Kamiya Biomedical Co. | 05/14/1999SE |
| K991210 | K-Assay CRP Calibrator SetDCK · Traditional | Kamiya Biomedical Co. | 05/11/1999SE |
| K990704 | Array 360 System C-Reactive Protein (CRP Mpe) ReagentDCK · Traditional | Beckman Coulter, Inc. | 05/03/1999SE |
| K990886 | Immulite C-Reactive Protein, Model LKCR1, LKCR5DCK · Special | Diagnostic Products Corp. | 04/06/1999SE |
| K984132 | Immulite C-Reactive Protein, Models LKC1, LKC5DCK · Traditional | Diagnostic Products Corp. | 01/28/1999SE |
| K981871 | C-Reactive Protein Elisa, Model Number DSL-10-42100DCK · Traditional | Diagnostic Systems Laboratories, Inc. | 11/09/1998SE |
| K982087 | Roche CRP T Control NDCK · Traditional | Roche Diagnostic Systems, Inc. | 08/18/1998SE |
| K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) ReagentDCK · Traditional | Beckman Coulter, Inc. | 06/12/1998SE |
| K973692 | Ubi Magiwel C-Reactive Protein(Crp) QuantitativeDCK · Traditional | United Biotech, Inc. | 02/09/1998SE |
| K974050 | Synchron Systems C-Reactive Protein (CRP) ReagentDCK · Traditional | Beckman Instruments, Inc. | 11/24/1997SE |
| K972160 | Crp-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex…DCK · Traditional | Trinity Laboratories, Inc. | 08/01/1997SE |
| K965110 | N-Assay Tia Multi CRP Calibrator SetDCK · Traditional | Crestat Diagnostics, Inc. | 07/03/1997SE |
| K962049 | C-Reactive Protein (CRP) Agglutination Latex KitDCK · Traditional | Polymedco, Inc. | 12/18/1996SE |
| K962019 | C-Reactive Protein (Crp):A Latex Slide TestDCK · Traditional | Teco Diagnostics | 11/25/1996SE |
| K963061 | Immage Immunochemistry System C-Reactive Protein (CRP) ReagentDCK · Traditional | Beckman Instruments, Inc. | 11/04/1996SE |
| K961829 | Qualitrol CRP Control SetDCK · Traditional | Consolidated Technologies, Inc. | 08/19/1996SE |
| K962373 | N/T Rheumatology Control SL/1 and SL/2DCK · Traditional | Behring Diagnostics, Inc. | 07/11/1996SE |
| K962523 | N Latex CRP Mono ReagentDCK · Traditional | Behring Diagnostics, Inc. | 07/10/1996SE |
| K960702 | Crp-Latex Seiken XR Reagent SystemDCK · Traditional | Globe Management Support, Inc. | 04/19/1996SE |
| K960324 | Hemagen CRP 150 Kit (Eia Method)DCK · Traditional | Hemagen Diagnostics, Inc. | 03/12/1996SE |
| K955156 | Wako Autokit CRP NewDCK · Traditional | Wako Chemicals USA, Inc. | 02/16/1996SE |
| K954447 | C-Reactive Protein Latex KitDCK · Traditional | Randox Laboratories, Ltd. | 12/18/1995SE |
| K953926 | Linical Protein III Calibration Verifiers Levels A-E for Beckman Array Protein SystemDCK · Traditional | International Enzymes, Inc. | 09/15/1995SE |
| K953207 | Human C-Reactive Protein Kit (Modification)DCK · Traditional | The Binding Site, Ltd. | 08/01/1995SE |
| K953212 | C-Reactive Protein Immunoturbidimetric Kit & CRP CalibratorDCK · Traditional | Randox Laboratories, Ltd. | 07/31/1995SE |
| K953197 | Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP)DCK · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 07/31/1995SE |
| K951057 | Mas Liquid Assayed Alcohol/Ammonia Control Level 1 and 2DCK · Traditional | Medical Analysis Systems, Inc. | 04/20/1995SE |
| K945280 | Dupont Dimension C-Reactive Protein MethodDCK · Traditional | Dupont Medical Products | 03/09/1995SE |
| K946050 | Liquispex(Tm) Liquid CRP Control Level 1 and 2DCK · Traditional | Clinical Controls, Inc. | 02/10/1995SE |
| K944375 | N/T Rheumatology Control SL/1, SL/2DCK · Traditional | Behring Diagnostics, Inc. | 10/03/1994SE |
| K944288 | Hemagen C-Reactive Protein Kit (Eia Method)DCK · Traditional | Hemagen Diagnostics, Inc. | 10/03/1994SE |
| K930621 | Tina-Quant CRPDCK · Traditional | Boehringer Mannheim Corp. | 03/10/1993SE |
| K924332 | Accutex CRP Latex TestDCK · Traditional | J.S. Medical Assoc. | 12/07/1992SE |
| K920845 | Vigil IIDCK · Traditional | Beckman Instruments, Inc. | 12/07/1992SE |
| K923768 | Pulse CRP TestDCK · Traditional | Pulse Scientific, Inc. | 12/01/1992SE |
| K922722 | Tech Dimple C-Reactive Protein Serum ControlDCK · Traditional | Simplicity Diagnostics, Inc. | 10/05/1992SE |
| K914155 | Tia CRP Test KitDCK · Traditional | Crestat Diagnostics, Inc. | 01/15/1992SE |
| K905633 | Human C-Reactive Protein Rid KitDCK · Traditional | The Binding Site, Ltd. | 07/22/1991SE |
| K904312 | Rheumagen CRP T-ControlDCK · Traditional | Biokit USA, Inc. | 10/01/1990SE |
| K895598 | Wako(Tm) Autokit CRPDCK · Traditional | Wako Chemicals USA, Inc. | 09/27/1989SE |
| K894573 | Scanlisa Human CRP Elisa KitDCK · Traditional | Immuntech A/S | 08/10/1989SE |
| K892526 | SPQ TM Test System II for CRPDCK · Traditional | Atlantic Antibodies | 05/09/1989SE |
| K892198 | Technicon DPA-1 (TM) CRP MethodDCK · Traditional | Technicon Instruments Corp. | 05/09/1989SE |
| K892146 | C Reactive Protein LiquidDCK · Traditional | Ampcor, Inc. | 04/14/1989SE |
| K892119 | Quik-Dot C Reactive ProteinDCK · Traditional | Ampcor, Inc. | 04/14/1989SE |
| K890423 | V-Trend Target CRP TestDCK · Traditional | Texas Immunology, Inc. | 02/17/1989SE |
| K884101 | Du Pont Dimension C-Reactive Protein CalibratorDCK · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/19/1988SE |
| K882998 | Acute Phase C-Reactive Protein Latex Agglu. TestDCK · Traditional | Amtec Diagnostics International, Inc. | 09/07/1988SE |
| K880729 | Kallestad QM300 Calibrator C PackDCK · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/30/1988SE |
| K880730 | Kallestad QM2/QM300 Control C PackDCK · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/25/1988SE |
| K875345 | Vision(R) CRPDCK · Traditional | Abbott Laboratories | 03/21/1988SE |
| K880016 | Modified CRP Latex TestDCK · Traditional | Sclavo, Inc. | 02/25/1988SE |
| K873865 | CRPDCK · Traditional | Unipath , Ltd. | 10/13/1987SE |
| K871895 | Tina-Quant [A] CRPDCK · Traditional | Boehringer Mannheim Corp. | 06/15/1987SE |
| K871055 | Precimat(R) CRPDCK · Traditional | Boehringer Mannheim Corp. | 05/06/1987SE |
| K864131 | Vision(Tm) CRPDCK · Traditional | Abbott Laboratories | 03/16/1987SE |
| K863628 | C-Reactive Protein (CRP), for Technicon Ra SystemsDCK · Traditional | Technicon Instruments Corp. | 10/15/1986SE |
| K863329 | Aca(R) C-Reactive Protein (CRP) CalibratorDCK · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/26/1986SE |
| K863328 | Aca(R) C-Reactive Protein (CRP) Analytical TestDCK · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/26/1986SE |
| K860550 | Du Pont C-Reactive Protein (CRP) AssayDCK · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/10/1986SE |
| K860549 | Du Pont C-Reactive Protein (CRP) CalibratorDCK · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/10/1986SE |
| K854542 | TDX C-Reactive ProteinDCK · Traditional | Abbott Laboratories | 01/24/1986SE |
| K854221 | Diesse CRP Test KitDCK · Traditional | Marvic Interpharma, Inc. | 11/25/1985SE |
| K851842 | SPQ Test System for C-Reactive ProteinDCK · Traditional | Atlantic Antibodies | 06/05/1985SE |
| K850160 | Fisher Diagnostics Latest-Crp Test KitDCK · Traditional | Fisher Diagnostics | 04/19/1985SE |
| K850590 | SPQ Test System for C-Reactive ProteinDCK · Traditional | Applications Lab | 03/01/1985SE |
| K841862 | Immu-TecDCK · Traditional | Medilab Corp. | 06/13/1984SE |
| K832054 | Fiax CRP Test KitDCK · Traditional | Intl. Diagnostic Technology | 08/26/1983SE |
| K831958 | Radial Immuno-Test for Human C-ReactiDCK · Traditional | Kent Laboratories, Inc. | 07/19/1983SE |
| K823417 | Prisma-C-Reactive Protein CalibratorsDCK · Traditional | Syva Co. | 12/09/1982SE |
| K823416 | Prisma C-Reactive Protein AssayDCK · Traditional | Syva Co. | 12/09/1982SE |
| K823415 | Prisma C-Reactive Protein ControlsDCK · Traditional | Syva Co. | 12/09/1982SE |
| K822067 | Emit C-Reactive Protein AutocarouselDCK · Traditional | Syva Co. | 07/27/1982SE |
| K821984 | Quantimetric 2 C-Reactive Protein Reag.DCK · Traditional | Kallestad Laboratories, Inc. | 07/22/1982SE |
| K821412 | C-Reactive Protein ControlDCK · Traditional | Syva Co. | 07/22/1982SE |
| K811617 | Quantimetric C-Reactive Protein Assay R.DCK · Traditional | Kallestad Laboratories, Inc. | 06/25/1981SE |
| K791461 | Agglutinotest-C-Reactive ProteinDCK · Traditional | Volu Sol Medical Industries | 12/31/1979SE |
| K792238 | CrptellDCK · Traditional | Central Biological Co. | 11/30/1979SE |
| K791560 | Goat Anti-Human C-Reactive ProteinDCK · Traditional | Protos Laboratories | 09/24/1979SE |
| K791650 | Human, C-Reactive Protein (CRP)DCK · Traditional | Beckman Instruments, Inc. | 09/17/1979SE |
| K760354 | Test, Slide for C-Reative ProteinDCK · Traditional | Icl Scientific | 08/11/1976SE |
| K760035 | Test, C-Reative Protein, Latex SlideDCK · Traditional | Gamma Biologicals, Inc. | 08/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1876-2025 Class II | VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides…Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge… | Ortho-Clinical Diagnostics, Inc. | 04/14/2025Open, Classified |
| Z-0535-2025 Class II | VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures…May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less… | Ortho-Clinical Diagnostics, Inc. | 10/11/2024Open, Classified |
| Z-1286-2023 Class II | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of…The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples.… | Randox Laboratories | 02/01/2023Open, Classified |
| Z-0864-2017 Class III | VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit)…CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent… | Ortho-Clinical Diagnostics | 10/26/2016Terminated |
| Z-0309-2014 Class II | VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-1615-2013 Class III | VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809…While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of… | Ortho-Clinical Diagnostics | 05/09/2013Terminated |
| Z-1178-2013 Class II | The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette…The Alere Cholestech LDX hsCRP cassette (PN 12-807) may have increased imprecision relative to the… | Alere San Diego, Inc. | 03/06/2013Terminated |
| Z-2631-2017 Class III | Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide…Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are… | Medtest Holdings, Inc. | 07/21/2009Terminated |
| Z-0973-2010 | "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated…The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP… | Kamiya Biomedical Company, LLC | 05/01/2009Terminated |
| Z-0921-2010 | IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280.…IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples… | Beckman Coulter Inc | 01/10/2008Terminated |
| Z-2457-2008 | Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The…Test results are high, outside of control material upper limit specification. Results could be as high as 15%. | Cholestech Corp | 08/09/2006Terminated |