LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K965133
    Device Name
    ANCA COMBI DIAGNOSTIC TEST KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1997-05-21

    (149 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This indirect immunofluorescence kit, with ethanol and formalin fixed human neutrophils as a substrate, is for the screening and titration of circulating anti-neutrophil cytoplasmic antibodies (ANCA). These antibodies are markers for the diagnosis and other systemic vasculitides.

    Device Description

    Not Found

    AI/ML Overview

    This appears to be a 510(k) clearance letter from the FDA. It indicates that a device, the "ANCA Combi Diagnostic Test Kit," has been found substantially equivalent to a legally marketed predicate device.

    However, the provided text does not contain any information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, or adjudication methods), or any multi-reader multi-case (MRMC) or standalone studies.

    The letter is a regulatory document confirming clearance, not a summary of the test data or clinical study results that led to that clearance.

    Therefore, I cannot provide the requested information from the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1