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    K Number
    K163504
    Device Name
    Borrelia B31 ViraChip IgG Test Kit
    Manufacturer
    VIRAMED BIOTECH AG
    Date Cleared
    2017-07-12

    (210 days)

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

    Borrelia B31 ViraChip IgG Test Kit

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

    The Viramed Biotech AG Borrelia B31 ViraChip® IgG Test Kit is an in vitro qualitative protein microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyne disease.

    The Borrelia B31 ViraChip® IgG Test Kit must be used with a ViraChip® Reader and the ViraChip® Software.

    Device Description

    The Viramed Biotech AG Borrelia B31 ViraChip® IgG Test Kit is an in vitro qualitative protein microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyne disease.

    The Borrelia B31 ViraChip® IgG Test Kit must be used with a ViraChip® Reader and the ViraChip® Software.

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the "Borrelia B31 ViraChip IgG Test Kit." This document does not contain the detailed acceptance criteria and performance study results as it is an approval letter, not the submission itself. The letter states that the FDA has "reviewed your Section 510(k) premarket notification" and "determined the device is substantially equivalent" to a predicate device.

    Therefore, I cannot provide the requested information based on the provided text. The information requested, such as specific acceptance criteria for performance metrics (sensitivity, specificity), sample sizes, ground truth establishment methods, or details about comparative effectiveness studies, would typically be found in the manufacturer's 510(k) submission, which is not provided here.

    The document does include the "Indications for Use" for the device, which describes its intended purpose.

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