BEUDAMED
    Product Code: NHX FDA class 2 21 CFR 866.5775

    Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

    Immunology

    The Anti-Cyclic Citrullinated Peptide (CCP) Antibodies test is an in vitro diagnostic device used for the detection of anti-CCP antibodies in human serum or plasma, serving as an aid in the diagnosis of rheumatoid arthritis. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NHX and regulation 21 CFR 866.5775 in the Immunology specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    21
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    11
    Years Active
    14

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    Basic Information

    Product Code
    NHX
    Device Class
    FDA class 2
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 21 510(k) clearances via K numbers.

    K Number Device Name
    K153551 ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
    K143754 QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
    K121576 IMMULITE 2000 ANTI-CCP IGG ASSAY
    K112810 MULTI-ANALYTE DETECTION SYSTEMS
    K110296 AXIS-SHIELD ANTI-CCP
    K093908 CCPOINT
    K093954 BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
    K090753 THERATEST EL-ANTI-CCP/2
    K091657 IMMUNOSCAN CCPLUS
    K083868 ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
    K081338 ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
    K072944 QUANTA LITE CCP3.1 IGG/IGA ELISA
    K070789 EUROIMMUN ANTI-CCP ELISA
    K063347 AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
    K062045 EDIA ANTI-CCP
    K061165 ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
    K052133 IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
    K052264 QUANTA LITE CCP3 IGG ELISA
    K023285 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
    K021516 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
    K020414 QUANTA LITE CCP ELISA

    FEI Numbers

    This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.