Product code NHX
- Device name
- Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5775
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | Axis-Shield Diagnostics Limited | 2016-08-04 |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | Inova Diagnostics, Inc. | 2015-09-21 |
| K121576 | IMMULITE 2000 ANTI-CCP IGG ASSAY | Siemens Healthcare Diagnostics, Inc. | 2013-04-04 |
| K112810 | MULTI-ANALYTE DETECTION SYSTEMS | Bio-Rad Laboratories | 2011-10-26 |
| K110296 | AXIS-SHIELD ANTI-CCP | Axis-Shield Diagnostics, Ltd. | 2011-08-18 |
| K093908 | CCPOINT | Euro-Diagnostica AB | 2010-12-01 |
| K093954 | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | 2010-08-24 |
| K090753 | THERATEST EL-ANTI-CCP/2 | Theratest Laboratories, Inc. | 2010-03-05 |
| K091657 | IMMUNOSCAN CCPLUS | Euro-Diagnostica AB | 2009-11-19 |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | Axis-Shield Diagnostics, Ltd. | 2009-09-25 |
| K081338 | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP | Roche Diagnostics | 2008-09-11 |
| K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA | Inova Diagnostics, Inc. | 2008-03-05 |
| K070789 | EUROIMMUN ANTI-CCP ELISA | Euroimmun Us, LLC | 2007-12-31 |
| K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 | Axis-Shield Diagnostics, Ltd. | 2007-03-20 |
| K062045 | EDIA ANTI-CCP | Euro-Diagnostica AB | 2006-12-04 |
| K061165 | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 | Sweden Diagnostics (Us), Inc. | 2006-08-03 |
| K052133 | IMMUNOSCAN RA ANTI-CCP TEST SYSTEM | Eurodiagnostica | 2005-12-12 |
| K052264 | QUANTA LITE CCP3 IGG ELISA | Inova Diagnostics, Inc. | 2005-11-23 |
| K023285 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA | Axis-Shield Diagnostics, Ltd. | 2002-10-09 |
| K021516 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 | Axis-Shield Diagnostics, Ltd. | 2002-07-23 |
| K020414 | QUANTA LITE CCP ELISA | Inova Diagnostics, Inc. | 2002-04-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07333066024202 | EliA IgG Calibrator Well | Phadia AB | 2026-01-29 |
| 07333066015798 | EliA CCP Well | Phadia AB | 2026-01-29 |
| 03610522053131 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2019-11-27 |
| 05055845400497 | Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA | AXIS-SHIELD DIAGNOSTICS LIMITED | 2019-08-02 |
| 07333066020020 | EliA CCP Positive Control 2500/5000 | Phadia AB | 2019-03-29 |
| 07333066012636 | EliA Sample Diluent | Phadia AB | 2016-09-23 |
| 07333066014647 | EliA CCP Well | Phadia AB | 2016-09-23 |
| 07333066014616 | EliA Dummy Well | Phadia AB | 2016-09-23 |
| 07333066014609 | EliA IgG Calibrator Well | Phadia AB | 2016-09-23 |
| 07333066013060 | EliA CCP Positive Control 100 | Phadia AB | 2016-09-23 |
| 07333066013015 | EliA CCP Positive Control 250 | Phadia AB | 2016-09-23 |
| 07333066012872 | EliA Sample Diluent | Phadia AB | 2016-09-23 |
| 07333066012827 | EliA IgG Conjugate 200 | Phadia AB | 2016-09-23 |
| 07333066012810 | EliA IgG Conjugate 50 | Phadia AB | 2016-09-23 |
| 07333066012803 | EliA IgG Curve Control Strip | Phadia AB | 2016-09-23 |
| 07333066012797 | EliA IgG Calibrator Strip | Phadia AB | 2016-09-23 |
| 07333066012704 | EliA IgG Curve Control | Phadia AB | 2016-09-23 |
| 07333066012629 | EliA IgG Conjugate | Phadia AB | 2016-09-23 |
| 04015630938827 | Elecsys AntiCCP Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 00847865010986 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002288 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000840 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000833 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000819 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950448358 | QUANTA Lite® CCP3 IgG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950622208 | QUANTA Flash® CCP3 Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593690 | QUANTA Lite® CCP3.1 IgG/IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593393 | QUANTA Lite® CCP3 IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950456124 | QUANTA Lite® CCP3.1 IgG/IgA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 00380740002039 | ARCHITECT | Abbott GmbH | 2016-06-06 |