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510(k) Data Aggregation

    K Number
    K980759
    Device Name
    DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    1998-04-23

    (55 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

    For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody. These reagents can be used either manually or in conjunction with the MAGO® or MAGO® PLUS Automated EIA Processors.

    Device Description

    The Is-ENA-6 Screen Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to six extractable nuclear antigens (ENAs), in human serum.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance

    The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for sensitivity, specificity, or agreement that the device must meet to be considered acceptable. Instead, it presents the performance characteristics of the Is-ENA-6 Screen Test System and compares them to a "comparative method" (a predicate device). The implication is that performance comparable to or better than the predicate device, across multiple testing modalities (manual, MAGO, MAGO PLUS), constitutes acceptable performance.

    However, based on the reported performance, we can infer what might be considered acceptable by showing strong correlation and similar diagnostic accuracy to the predicate device.

    Inferred Acceptance Criteria & Reported Device Performance Table:

    Performance MetricInferred Acceptance Criteria (Implicit: Comparable to Predicate)Reported Device Performance (Worst Case across Manual, MAGO, MAGO PLUS)
    Relative SensitivityHigh (e.g., >80% and comparable to predicate)92.0% (84.3-96.7% CI)
    Relative SpecificityHigh (e.g., >90% and comparable to predicate)97.2% (93.1-99.2% CI)
    Overall AgreementHigh (e.g., >90% and comparable to predicate)95.3% (91.8-97.6% CI)
    Precision (Intra-assay CV)Low (e.g.,
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