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510(k) Data Aggregation

    K Number
    K031177
    Device Name
    DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
    Manufacturer
    AXIS-SHIELD DIAGNOSTICS, LTD.
    Date Cleared
    2003-06-19

    (66 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

    The Diastat ™Anti Beta 2 GLYCOPROTEIN I IgM test is a semi-quantitative/qualitative enzyme-linked immunosorbent Assay (ELISA) for the detection the IgM class of autoantibodies to b2 GP1 in human serum, or sodium citrate, EDTA(K2), and lithium heparin anti-coagulated plasma. It is intended to aid in the assessment of thrombotic risk in patients with autoimmune disease associated with thrombotic disorders such as those with Primary Anti Phospholipid Syndrome (PAPS) or secondary to Systemic Lupus Erythematosus and is not definitive in isolation. Autoantibody levels represent one parameter in a multicriterion diagnostic process.

    Device Description

    semi-quantitative/qualitative enzyme-linked immunosorbent Assay (ELISA) for the detection the IgM class of autoantibodies to b2 GP1 in human serum, or sodium citrate, EDTA(K2), and lithium heparin anti-coagulated plasma.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Diastat™ Anti-BETA 2 GLYCOPROTEIN 1 IgM" device. This document primarily focuses on FDA regulatory approval and does not contain the detailed study information required to answer your request about acceptance criteria and device performance.

    Therefore, I cannot provide the requested information. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes, data provenance, or details about the test set.
    3. Number of experts, their qualifications, or adjudication methods for ground truth.
    4. Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
    5. Types of ground truth used (beyond implying autoantibody detection in human samples).
    6. Sample size or ground truth establishment for a training set.
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