LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K052133
    Device Name
    IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
    Manufacturer
    EURODIAGNOSTICA
    Date Cleared
    2005-12-12

    (129 days)

    Product Code
    NHX
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Immunoscan RA anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.

    Device Description

    The Immunoscan RA anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment for a device. The document is an FDA 510(k) clearance letter for the "Immunoscan RA anti-CCP Test Kit," confirming its substantial equivalence to a predicate device for the diagnosis of Rheumatoid Arthritis. It outlines regulatory information but does not detail the specific performance studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1