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510(k) Data Aggregation

    K Number
    K970237
    Device Name
    IS-ANTI-SSB TEST SYSTEM (720-260)
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    1997-04-08

    (77 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The assay is intended for use in detecting antibodies to SSB (La) antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.

    Device Description

    The Is-anti-SSB Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to SSB (La) antigen in human serum.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Diamedix Is-anti-SSB Test System, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    CriteriaAcceptance Criteria (Implied)Reported Device Performance (Manual)Reported Device Performance (MAGO)
    Relative SensitivityHigh sensitivity for detecting autoantibodies (e.g., ≥ 80-90%)95% (38/40 sera)95% (38/40 sera)
    Relative SpecificityHigh specificity to avoid false positives (e.g., ≥ 95%)100% (124/124 sera)100% (124/124 sera)
    AgreementHigh concordance with a predicate device (e.g., ≥ 95%)99% (162/164 sera)99% (162/164 sera)
    LinearityStrong linear relationship between dilution and absorbanceR² = 0.9829 (Manual)R² = 0.9874 (MAGO)
    PrecisionLow intra- and inter-assay variability (e.g., CV%
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