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510(k) Data Aggregation

    K Number
    K030702
    Device Name
    IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2003-09-09

    (187 days)

    Product Code
    MSV
    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

    An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgM antibodies to B2-GP1, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) or lupus like disorders

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but after reviewing the document, I could not find information regarding the specific acceptance criteria for the ImmuLisa Anti-Beta2 Glycoprotein I (ß2GP1) IgM ELISA device, nor details about a study that proves the device meets such criteria.

    The document primarily consists of a 510(k) clearance letter from the FDA, confirming the device's substantial equivalence to a legally marketed predicate device. It also includes an "Indications For Use Statement." While it mentions the device is an "enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgM antibodies to B2-GP1, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) or lupus like disorders," it does not provide performance metrics, study designs, sample sizes, or information about ground truth establishment.

    Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

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