System, Test, C-Reactive Protein
FDA product code DCN · Class II (moderate risk) · 21 CFR 866.5270 · Immunology
70510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Roche Diagnostics Corp. 4
- Good Biotech Corp. 4
- The Binding Site Group , Ltd. 3
- Dade Behring, Inc. 3
- Biokit USA, Inc. 2
- Abbott Laboratories 2
- Syn-Kit, Inc. 2
- Wako Chemicals USA, Inc. 2
- Kallestad Diag, A Div. of Erbamont, Inc. 2
- Olympus America, Inc. 2
- Texas Immunology, Inc. 2
- Behring Diagnostics, Inc. 2
- Diagnostic Technology, Inc. 1
- Difco Laboratories, Inc. 1
- Intl. Diagnostic, Inc. 1
- Immunostics Inc., 1
- Siemens Healthcare Diagnostic Products GmbH 1
- Syva Co. 1
- Armkel, LLC 1
- Biologics Intl., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232624 | CardioPhase® hsCRPDCN · Traditional | Siemens Healthcare Diagnostic Products GmbH | 11/27/2023SE |
| K221119 | RCRP Flex reagent cartridgeDCN · Special | Siemens Healthcare Diagnostics, Inc. | 03/17/2023SE |
| K192072 | Tina-quant C-Reactive Protein IVDCN · Traditional | Roche Diagnostics Operations (Rdo) | 02/21/2020SE |
| K180099 | Optilite High Sensitivity C-Reactive Protein KitDCN · Traditional | The Binding Site Group , Ltd. | 10/12/2018SE |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite…DCN · Traditional | The Binding Site Group , Ltd. | 02/28/2018SE |
| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentDCN · Traditional | Meso Scale Diagnostics, LLC | 01/12/2018SE |
| K161982 | C-Reactive Protein Kit for use on SPAPLUSDCN · Traditional | The Binding Site Group | 04/05/2017SE |
| K113809 | Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)DCN · Traditional | Hitachi Chemical Diagnostics, Inc. | 08/17/2012SE |
| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | Abaxis, Inc. | 01/15/2010SE |
| K083444 | C-Reactive Protein (Latex)DCN · Traditional | Roche Diagnostics Corp. | 03/18/2009SE |
| K083412 | Pathfast HscrpDCN · Traditional | Mitsubishi Kagaku Iatron | 03/09/2009SE |
| K083040 | S-Test C-Reactive Protein (CRP)DCN · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 01/30/2009SE |
| K072658 | Advia Chemistry C-Reactive PROTEIN_2, (CRP_2) and CalibratorsDCN · Traditional | Siemens Medical Solutions Diagnostics | 04/01/2008SE |
| K073277 | Roche-Creactive Protein (Latex)DCN · Special | Roche Diagnostics Corp. | 03/06/2008SE |
| K062981 | I-Chroma CRP TestDCN · Traditional | Boditech Diagnostics, Inc. | 07/13/2007SE |
| K061825 | Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and…DCN · Traditional | Dade Behring, Inc. | 09/06/2006SE |
| K050713 | Duet Hs-Crp Lit Assay, Catalog Number: 4010, Duet Hs-Crp Calibrator Set, Catalog Number:…DCN · Traditional | Good Biotech Corp. | 06/06/2005SE |
| K040030 | Biocheck CARDIAC-1 CRP Rapid Test, Model BC-804114DCN · Traditional | Biocheck, Inc. | 06/16/2004SE |
| K032336 | Tina-Quant CRP (Latex)DCN · Special | Roche Diagnostics Corp. | 08/05/2003SE |
| K030899 | C-Reactive Protein (CRP)DCN · Traditional | Abbott Laboratories | 07/02/2003SE |
| K022690 | Paros CRPDCN · Traditional | Horiba, Ltd. | 12/23/2002SE |
| K021757 | Crpex-Br C-Reactive Protein Lit Assay, Crpex-Br CRP Calibrator SetDCN · Traditional | Good Biotech Corp. | 07/29/2002SE |
| K021572 | Synchron Systems C-Reactive Protein (C-Rp) Reagent; Synchron Systems CX C-Rp CalibratorDCN · Traditional | Beckman Coulter, Inc. | 07/19/2002SE |
| K021882 | Crpex-Hs CRP Calibrator Set, Catalog No: 1510DCN · Traditional | Good Biotech Corp. | 07/11/2002SE |
| K020603 | Crpex-Hs C-Reactive Protein Lit Assay, Catalog No. 1010DCN · Traditional | Good Biotech Corp. | 06/13/2002SE |
| K011855 | Wampole Hs-Crp ElisaDCN · Traditional | Carter-Wallace, Inc. | 01/08/2002SE |
| K012337 | Bayer Advia Ims System; C-Reactive Protein SystemDCN · Traditional | Bayer Corp. | 12/06/2001SE |
| K011958 | Crp-Latex (II) Seiken High Sensitivity Assay KitDCN · Traditional | Denka Seiken'S | 12/04/2001SE |
| K003400 | CRP HS Test SystemDCN · Traditional | Roche Diagnostics Corp. | 05/10/2001SE |
| K003419 | RCRP Flex Reagent CartridgeDCN · Traditional | Dade Behring, Inc. | 02/14/2001SE |
| K003342 | Wako Crp-Ul, Crp-Ul Calibrator SetDCN · Traditional | Wako Chemicals USA, Inc. | 01/22/2001SE |
| K003372 | Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRPDCN · Traditional | Diagnostic Products Corp. | 12/26/2000SE |
| K002918 | Olympus CRP Latex Immunoturbidimetric ReagentDCN · Special | Olympus America, Inc. | 10/25/2000SE |
| K991372 | CRPDCN · Traditional | Abbott Laboratories | 06/01/1999SE |
| K990825 | Revised C-Reactive Protein (RCRP) Flex Reagent CartridgeDCN · Traditional | Dade Behring, Inc. | 04/16/1999SE |
| K974429 | Rapet CRPDCN · Traditional | Stanbio Laboratory | 02/18/1998SE |
| K954537 | Olympus C-Reactive Protein Immunoturbidimetric ReagentDCN · Traditional | Olympus America, Inc. | 02/14/1996SE |
| K955042 | Chromalex C-Reactive Protein Latex Test SystemDCN · Traditional | Shared Systems, Inc. | 12/13/1995SE |
| K935075 | SPQ CRP Control Level IIDCN · Traditional | Incstar Corp. | 01/11/1994SE |
| K932180 | Eye Spot CRP TestDCN · Traditional | J.S. Medical Assoc. | 08/23/1993SE |
| K910535 | Synchron C-Reactive Protein ReagentDCN · Traditional | Beckman Instruments, Inc. | 04/12/1991SE |
| K910686 | Rheumajet CRPDCN · Traditional | Biokit USA, Inc. | 03/19/1991SE |
| K904497 | Cromatest Rheumatoid Diagnostic/Crp Latex TestDCN · Traditional | Biotrax, Inc. | 11/01/1990SE |
| K903853 | Rapitex (R) CRP NewDCN · Traditional | Behring Diagnostics, Inc. | 08/30/1990SE |
| K902593 | Raichem(Tm) Spia(Tm) CRP ReagentDCN · Traditional | Reagents Applications, Inc. | 06/28/1990SE |
| K896272 | Quantex CRP Plus (Latex, Buffer, Standard, ControlDCN · Traditional | Biokit USA, Inc. | 11/08/1989SE |
| K892231 | V-Trend Target CRP TestDCN · Traditional | Texas Immunology, Inc. | 04/21/1989SE |
| K885001 | QM300 PCR Antibody PackDCN · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 12/20/1988SE |
| K883515 | Du Pont Dimension C-Reactive Protein MethodDCN · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/22/1988SE |
| K882374 | Wako(Tm) CRPDCN · Traditional | Wako Chemicals USA, Inc. | 07/08/1988SE |
| K880728 | Kallestad QM300 C-Reactive Protein Antibody PackDCN · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/25/1988SE |
| K872539 | Eurogenetics CRP ElisaDCN · Traditional | Eurogenetics | 10/20/1987SE |
| K860679 | Immunochemical Assay of C-Reactive ProteinDCN · Traditional | Orion Corp. | 08/04/1986SN |
| K855057 | Laser CRP Kit(C-Reactive Protein Reagents)DCN · Traditional | Behring Diagnostics, Inc. | 02/26/1986SE |
| K854819 | CPR Slide EikenDCN · Traditional | Syn-Kit, Inc. | 02/26/1986SE |
| K841265 | Tago Diffu-Gen C-Reactive ProteinDCN · Traditional | Tago, Inc. | 05/22/1984SE |
| K840699 | CRP Slide Test KitDCN · Traditional | Difco Laboratories, Inc. | 03/23/1984SE |
| K834584 | Nabi Crp-Q.S. TestDCN · Traditional | Intl. Diagnostic, Inc. | 02/27/1984SE |
| K834390 | Immuno-CrpDCN · Traditional | Immunostics Co., Inc. | 02/03/1984SE |
| K831465 | Crp-CheckDCN · Traditional | Diagnostic Technology, Inc. | 06/08/1983SE |
| K831364 | Testcorp RaDCN · Traditional | Myo-Tronics Research, Inc. | 05/27/1983SE |
| K831362 | Testcorp CRPDCN · Traditional | Catheter Technology Corp. | 05/27/1983SE |
| K821388 | Sero/Tex CRP TestDCN · Traditional | Texas Immunology, Inc. | 07/02/1982SE |
| K821413 | Emit C-Reactive Protein AssayDCN · Traditional | Syva Co. | 05/28/1982SE |
| K812881 | Immunex CRPDCN · Traditional | Armkel, LLC | 10/26/1981SE |
| K811374 | Bi-Crp Latex TestDCN · Traditional | Biologics Intl., Inc. | 06/12/1981SE |
| K810862 | CRP SlideDCN · Traditional | Syn-Kit, Inc. | 04/08/1981SE |
| K790716 | Antiserum to Human C-Reactive ProteinsDCN · Traditional | Kent Laboratories, Inc. | 08/03/1979SE |
| K771535 | Las-R Human CRP TestDCN · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 09/02/1977SE |
| K771139 | Crp-WellcotestDCN · Traditional | Burroughs Wellcome Co. | 07/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1551-2025 Class II | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. | Siemens Healthcare Diagnostics, Inc. | 03/11/2025Open, Classified |
| Z-0634-2021 Class II | Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in…Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant… | Roche Diagnostics Operations, Inc. | 11/06/2020Terminated |
| Z-1619-2020 Class II | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI…A reagent in C reactive protein kits is not performing to specification and samples with known… | The Binding Site Group, Ltd. | 04/25/2019Terminated |
| Z-0671-2020 Class II | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent…Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits | The Binding Site Group, Ltd. | 02/19/2019Terminated |
| Z-1930-2009 | Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro…falsely elevated results in EDTA plasma samples | Siemens Healthcare Diagnostics, Inc. | 04/15/2008Terminated |