NHX — Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Class II
Classification Details
- Product Code
- NHX
- Device Class
- Class II
- Regulation Number
- 866.5775
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K153551 | axis-shield diagnostics limited | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Qual | August 4, 2016 |
| K143754 | inova diagnostics | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | September 21, 2015 |
| K121576 | siemens healthcare diagnostics | IMMULITE 2000 ANTI-CCP IGG ASSAY | April 4, 2013 |
| K112810 | bio-rad laboratories | MULTI-ANALYTE DETECTION SYSTEMS | October 26, 2011 |
| K110296 | axis-shield diagnostics | AXIS-SHIELD ANTI-CCP | August 18, 2011 |
| K093908 | euro-diagnostica | CCPOINT | December 1, 2010 |
| K093954 | bio-rad laboratories | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | August 24, 2010 |
| K090753 | theratest laboratories | THERATEST EL-ANTI-CCP/2 | March 5, 2010 |
| K091657 | euro-diagnostica | IMMUNOSCAN CCPLUS | November 19, 2009 |
| K083868 | axis-shield diagnostics | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P | September 25, 2009 |
| K081338 | roche diagnostics | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP | September 11, 2008 |
| K072944 | inova diagnostics | QUANTA LITE CCP3.1 IGG/IGA ELISA | March 5, 2008 |
| K070789 | euroimmun us | EUROIMMUN ANTI-CCP ELISA | December 31, 2007 |
| K063347 | axis-shield diagnostics | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L | March 20, 2007 |
| K062045 | euro-diagnostica | EDIA ANTI-CCP | December 4, 2006 |
| K061165 | sweden diagnostics (us) | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 | August 3, 2006 |
| K052133 | eurodiagnostica | IMMUNOSCAN RA ANTI-CCP TEST SYSTEM | December 12, 2005 |
| K052264 | inova diagnostics | QUANTA LITE CCP3 IGG ELISA | November 23, 2005 |
| K023285 | axis-shield diagnostics | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA | October 9, 2002 |
| K021516 | axis-shield diagnostics | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 | July 23, 2002 |