NHX — Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Class II
FDA product code NHX covers "Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)", a Class II medical device regulated under 21 CFR 866.5775. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |