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510(k) Data Aggregation

    K Number
    K974694
    Device Name
    IS-DSDNA TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    1998-03-03

    (77 days)

    Product Code
    LRM
    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

    lndications for Use :The Diamedix Is-dsDNA an Enzyme Immunoassay (ElA) for the detection and quantitative determination of IgG antibodies in human serum to DNA antigen as an aid in the diagnosis of systemic lupus erythematosus in patients with clinical signs of the disease. These reagents can be used either manually or in conjunction with the MAGO® Automated EIA Processor.

    Device Description

    The Is-dsDNA Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of IgG to DNA in human serum

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Diamedix Is-dsDNA Test System:

    Acceptance Criteria and Device Performance

    The document does not explicitly state pre-defined quantitative "acceptance criteria" for the study beyond implicitly demonstrating performance relative to a comparative method and typical characteristics for diagnostic assays (linearity, precision, cross-reactivity). The summary focuses on presenting the observed performance rather than comparing it against specific pre-set numerical targets for approval.

    However, based on the provided performance characteristics, we can infer some desired outcomes that would constitute "meeting acceptance criteria" in a general sense for a diagnostic device: good sensitivity and specificity, linearity, precision, and lack of significant cross-reactivity.

    Here's a table summarizing the reported device performance:

    Performance MetricAcceptance Criteria (Inferred from industry norms for diagnostic kits)Diamedix Is-dsDNA Test System Performance (Manual)Diamedix Is-dsDNA Test System Performance (MAGO)
    Relative Sensitivity (vs. comparative method)Typically high (e.g., >80-90%)94.9% (37/39) [95% CI: 82.7-99.4]90.6% (29/32) [95% CI: 75.0-98.0]
    Relative Specificity (vs. comparative method)Typically high (e.g., >95%)100.0% (199/199) [95% CI: 98.2-100]100.0% (201/201) [95% CI: 98.2-100.0]
    Overall AgreementTypically high (e.g., >90%)99.2% (236/238) [95% CI: 97.0-99.9]98.7% (230/233) [95% CI: 96.3-99.7]
    Linearity (R-squared)High (e.g., >0.95)0.9821 (Manual)0.9961 (MAGO)
    Intra-assay Precision (%CV)Low (e.g.,
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