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510(k) Data Aggregation

    K Number
    K983605
    Device Name
    IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1998-12-16

    (63 days)

    Product Code
    LSR
    Regulation Number
    866.3830
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

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

    For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.

    Device Description

    The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum.

    AI/ML Overview

    The provided 510(k) summary for the "Borrelia burgdorferi IgG/IgM ELISA Kit" details performance characteristics but does not explicitly state specific acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or precision that the device had to meet for clearance. Instead, it presents the device's performance results across various studies and implies that these results were considered acceptable by the FDA for substantial equivalence to a predicate device.

    However, based on the presented data, we can infer the reported device performance.

    1. Table of Acceptance Criteria and Reported Device Performance

    As specific acceptance criteria were not explicitly stated, the reported performance is presented as demonstrated.

    Performance MetricInferred Acceptance Criteria (Implicit)Reported Device Performance (Is-EIA)
    Clinical Sensitivity (CDC Panel)Sufficient agreement with characterized sera, particularly for later stages of infection. The predicate device's performance likely served as the benchmark.70.2% overall agreement (equivocal treated as positive). Specifically: 100% agreement for >1 Yr, 60% for 3-12 Months, 55.6% for 1-2 Months, 60% for 1 Yr, 100% for 3-12 Months, 76.9% for 1-2 Months, 74.4% for 1 Yr, 20 for 3-12 Months, 9 for 1-2 Months, 5 for 1 Yr, 13 for 3-12 Months, 13 for 1-2 Months, 43 for
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