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510(k) Data Aggregation

    K Number
    K991185
    Device Name
    BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1999-09-03

    (148 days)

    Product Code
    LSR
    Regulation Number
    866.3830
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zeus Scientific, Inc., B. burgdorferi Western Blot Test System is designed for the qualitative detection of IgM class antibodies to specific proteins associated with B. burgdorferi, the causative agent of Lyme Disease. This test system is intended to be used for testing human serum samples which have been found to be positive or equivocal by an EIA or IFA screening procedure. The test is therefore intended to provide supportive evidence of infection with Borrelia burgdorferi.

    Device Description

    Borrelia burgdorferi IgM Western Blot Test System

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria in the requested format. The document is an FDA 510(k) clearance letter confirming that the Borrelia burgdorferi IgM Western Blot Test System is substantially equivalent to legally marketed predicate devices. It does not include details on specific acceptance criteria for performance, the study design, sample sizes, expert qualifications, or ground truth establishment.

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