Atlas FDA

NHX

21 FDA 510(k) clearances · Product code

140 daysmedian time to decision
309 days90th percentile
21clearances measured

FDA profile

Official device name
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5775
Medical specialty
Immunology
Flags
Third-party review eligible
FDA 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.
Adverse events (MAUDE)
2019: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. (K153551)Axis-Shield Diagnostics Limited2016-08-04
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 (K143754)Inova Diagnostics, Inc.2015-09-21
IMMULITE 2000 ANTI-CCP IGG ASSAY (K121576)Siemens Healthcare Diagnostics, Inc.2013-04-04
MULTI-ANALYTE DETECTION SYSTEMS (K112810)Bio-Rad Laboratories2011-10-26
AXIS-SHIELD ANTI-CCP (K110296)Axis-Shield Diagnostics, Ltd.2011-08-18
CCPOINT (K093908)Euro-Diagnostica AB2010-12-01
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K093954)Bio-Rad Laboratories2010-08-24
THERATEST EL-ANTI-CCP/2 (K090753)Theratest Laboratories, Inc.2010-03-05
IMMUNOSCAN CCPLUS (K091657)Euro-Diagnostica AB2009-11-19
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 (K083868)Axis-Shield Diagnostics, Ltd.2009-09-25
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP (K081338)Roche Diagnostics2008-09-11
QUANTA LITE CCP3.1 IGG/IGA ELISA (K072944)Inova Diagnostics, Inc.2008-03-05
EUROIMMUN ANTI-CCP ELISA (K070789)Euroimmun Us, LLC2007-12-31
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 (K063347)Axis-Shield Diagnostics, Ltd.2007-03-20
EDIA ANTI-CCP (K062045)Euro-Diagnostica AB2006-12-04
ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 (K061165)Sweden Diagnostics (Us), Inc.2006-08-03
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM (K052133)Eurodiagnostica2005-12-12
QUANTA LITE CCP3 IGG ELISA (K052264)Inova Diagnostics, Inc.2005-11-23
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA (K023285)Axis-Shield Diagnostics, Ltd.2002-10-09
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 (K021516)Axis-Shield Diagnostics, Ltd.2002-07-23
QUANTA LITE CCP ELISA (K020414)Inova Diagnostics, Inc.2002-04-29

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