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510(k) Data Aggregation

    K Number
    K994004
    Device Name
    QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2000-01-27

    (64 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 QUANTA Lite™ Lyme B. burgdorferi IgG/IgM ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the initial (first-step) qualitative detection of IgG and IgM antibodies to B. burgdorferi, the agent of Lyme disease (Lyme borreliosis), in human serum. This ELISA is intended to provide presumptive evidence of the presence of antibodies to B. burgdorferi. It should only be used for individuals with signs and symptoms consistent with Lyme disease. Equivocal or positive results should be followed by a standardized second-step supplemental procedure such as Western blot assays. Positive results on a second-step assay can support a clinical diagnosis of Lyme disease. Diagnosis of Lyme disease should be based on history, physical findings, and other laboratory data in addition to anti-B. burgdorferi results. Negative results should not be the sole basis for exclusion of B. burgdorferi infection.

    Device Description

    The QUANTA Lite™ Lyme B. burgdorferi IgG/IgM ELISA kit is an enzyme-linked immunosorbent assay (ELISA).

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific criteria. The document is an FDA 510(k) clearance letter for the "QUANTA Lite™ Lyme B. burgdorferi IgG/IgM ELISA" kit, indicating that the device has been found substantially equivalent to a legally marketed predicate device for the stated indications for use.

    While it mentions the device's purpose (initial qualitative detection of IgG and IgM antibodies to B. burgdorferi in human serum for individuals with signs and symptoms consistent with Lyme disease), it does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about sample sizes, data provenance, ground truth establishment, or expert involvement for any studies.
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

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