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510(k) Data Aggregation

    K Number
    K983740
    Device Name
    IS-ANTI-PR3 IGG ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1998-11-18

    (27 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

    The & PR-3 IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative detection and semi-quantitation of antibodies against the Proteinase-3 antigen in serum as an aid in the diagnosis of Wegeners granulomatosis. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.

    Device Description

    The & PR-3 IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Proteinase-3 in human serum.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Columbia Bioscience, Inc. & PR-3 IgG ELISA Kit based on the provided 510(k) summary:

    Acceptance Criteria and Device Performance

    The acceptance criteria are implied by the results presented in the performance studies, showing that the device achieved these values. Explicit pre-defined acceptance thresholds are not directly stated in the summary, but the reported performance serves as the basis for substantial equivalence.

    Table 1: Acceptance Criteria (Implied) and Reported Device Performance

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance
    Relative SensitivityHigh (e.g., >90%)100.0% (95% CI: 93.7-100%)
    Relative SpecificityHigh (e.g., >95%)97.9% (95% CI: 94.7-99.4)
    Overall AgreementHigh (e.g., >95%)98.4% (95% CI: 95.9-99.6)
    Clinical Specificity (Normals)High (e.g., >95%)98.3% (95% CI: 95.0-99.6)
    Clinical Sensitivity (Wegener's Granulomatosis)High (e.g., >90%)95.0% (95% CI: 83.1-91.4)
    Clinical Sensitivity (Microscopic Polyangiitis)Acceptable (Specific target not clear, but 55.3% is reported)55.3% (95% CI: 38.3-71.4)
    Correlation (Manual vs. MAGO Plus)Strong positive correlationPearson Correlation Coefficient: 0.983
    Precision (Intra-assay CV%)Low variability (e.g., 90% or >95%), and for precision, Coefficient of Variation (CV%) values are expected to be low (e.g.,
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