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    K Number
    K013956
    Device Name
    DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2002-01-08

    (39 days)

    Product Code
    MSV
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN

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

    The Diamedix Is anti-β,Glycoprotein I Screen Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to ß, glycoprotein I in human serum as an aid in the diagnosis of certain autoimmune thrombotic disorders in patients with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

    Device Description

    The Is anti B, Glycoprotein I Screen Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to ß, glycoprotein I in human serum

    AI/ML Overview

    The provided text describes the performance characteristics of the "Is anti-β₂Glycoprotein I Screen Test System". This device is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM, and IgA antibodies to β₂ glycoprotein I in human serum, intended as an aid in the diagnosis of certain autoimmune thrombotic disorders in patients with SLE or SLE-like disorders.

    Here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria for relative sensitivity, specificity, or overall agreement as a specific numerical threshold that the device must meet to be considered acceptable. Instead, it reports the observed performance and implicitly expects it to be within a reasonable range for an equivalent device. However, for clinical sensitivity and specificity, specific percentages are reported for different patient groups.

    Performance MetricAcceptance Criteria (Implicit)Reported Device Performance (Relative Study)Reported Device Performance (Clinical Study)
    Relative SensitivityHigh agreement with predicate71.6% (95% CI: 61.0-80.7%)N/A
    Relative SpecificityHigh agreement with predicate100.0% (95% CI: 96.2-100.0%)N/A
    Overall AgreementHigh agreement with predicate86.3% (95% CI: 81.4-91.3%)N/A
    Clinical Specificity (Normals)High specificity (implicitly >90%)N/A96.8% (240/248)
    Clinical Specificity (RPR Positive)High specificity (implicitly >80%)N/A86.7% (13/15)
    Clinical Specificity (Other Autoimmune)High specificity (implicitly >80%)N/A88.2% (30/34)
    Clinical Sensitivity (APS)Detects target condition (implicitly >80%)N/A84.2% (48/57)
    Clinical Sensitivity (SLE)Detects target condition (implicitly >30%)N/A30.3% (10/33)
    Manual vs. MAGO Plus Correlation (r)High correlation (implicitly >0.9)0.9667N/A
    Linearity (r)High linearity (implicitly >0.9)0.9904 (95% CI: 0.9456 to 0.9983)N/A
    Precision (CV%) - Manual (Interassay)Low variability (implicitly
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