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    K Number
    K960182
    Device Name
    DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
    Manufacturer
    MARDX DIAGNOSTICS, INC.
    Date Cleared
    1996-03-20

    (64 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM

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

    The assay is intended for use in detecting antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE).

    Device Description

    The dsDNA Immunoglobulin EIA test system is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of Immunoglobulin to dsDNA in human sera.

    AI/ML Overview

    This document describes the validation of the MarDx dsDNA Immunoglobulin EIA Test System, a device for detecting antibodies to dsDNA in human sera, intended as an aid in diagnosing Systemic Lupus Erythematosus (SLE).

    Here's an analysis of the provided information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, and accuracy for the MarDx dsDNA EIA Test System. Instead, it demonstrates substantial equivalence to a predicate device (Clark ELISA for dsDNA IgG, IgM antibodies) by presenting the comparative performance.

    However, based on the results, we can infer the desired performance levels relative to the predicate device. For precision, the acceptance criteria are implicit in the reported Coefficient of Variation (CV) values.

    Performance MetricAcceptance Criteria (Implied / Achieved)Reported Device Performance
    Relative SensitivitySubstantial equivalence to Clark dsDNA test (implicitly, high sensitivity)95.0% (38/40 true positives relative to the Clark test)
    Relative SpecificitySubstantial equivalence to Clark dsDNA test (implicitly, high specificity)100% (81/81 true negatives relative to the Clark test)
    Relative AccuracySubstantial equivalence to Clark dsDNA test (implicitly, high accuracy)98.3% (119/121 agreement relative to the Clark test)
    Intra-Assay Precision (CV)Generally,
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