NHX · Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Immunology · 21 CFR 866.5775 · Class 2
Overview
| Product Code | NHX |
|---|---|
| Device Name | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) |
| Regulation | 21 CFR 866.5775 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | Axis-Shield Diagnostics Limited | Aug 4, 2016 | SESE |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | Inova Diagnostics, Inc. | Sep 21, 2015 | SESE |
| K121576 | IMMULITE 2000 ANTI-CCP IGG ASSAY | Siemens Healthcare Diagnostics, Inc. | Apr 4, 2013 | SESE |
| K112810 | MULTI-ANALYTE DETECTION SYSTEMS | Bio-Rad Laboratories | Oct 26, 2011 | SESE |
| K110296 | AXIS-SHIELD ANTI-CCP | Axis-Shield Diagnostics, Ltd. | Aug 18, 2011 | SESE |
| K093908 | CCPOINT | Euro-Diagnostica AB | Dec 1, 2010 | SESE |
| K093954 | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | Aug 24, 2010 | SESE |
| K090753 | THERATEST EL-ANTI-CCP/2 | Theratest Laboratories, Inc. | Mar 5, 2010 | SESE |
| K091657 | IMMUNOSCAN CCPLUS | Euro-Diagnostica AB | Nov 19, 2009 | SESE |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | Axis-Shield Diagnostics, Ltd. | Sep 25, 2009 | SESE |
| K081338 | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP | Roche Diagnostics | Sep 11, 2008 | SESE |
| K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA | Inova Diagnostics, Inc. | Mar 5, 2008 | SESE |
| K070789 | EUROIMMUN ANTI-CCP ELISA | Euroimmun Us, LLC | Dec 31, 2007 | SESE |
| K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 | Axis-Shield Diagnostics, Ltd. | Mar 20, 2007 | SESE |
| K062045 | EDIA ANTI-CCP | Euro-Diagnostica AB | Dec 4, 2006 | SESE |
| K061165 | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 | Sweden Diagnostics (Us), Inc. | Aug 3, 2006 | SESE |
| K052133 | IMMUNOSCAN RA ANTI-CCP TEST SYSTEM | Eurodiagnostica | Dec 12, 2005 | SESE |
| K052264 | QUANTA LITE CCP3 IGG ELISA | Inova Diagnostics, Inc. | Nov 23, 2005 | SESE |
| K023285 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA | Axis-Shield Diagnostics, Ltd. | Oct 9, 2002 | SESE |
| K021516 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 | Axis-Shield Diagnostics, Ltd. | Jul 23, 2002 | SESE |
Top Applicants
- Axis-Shield Diagnostics, Ltd. — 5 clearances
- Inova Diagnostics, Inc. — 4 clearances
- Euro-Diagnostica AB — 3 clearances
- Bio-Rad Laboratories — 2 clearances
- Theratest Laboratories, Inc. — 1 clearance
