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510(k) Data Aggregation

    K Number
    K092553
    Device Name
    TRU FLU, MODEL 751230
    Manufacturer
    MERIDIAN BIOSCIENCE, INC.
    Date Cleared
    2009-09-11

    (22 days)

    Product Code
    PSZ,GNX
    Regulation Number
    866.3328
    Type
    Special
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples in symptomatic patients. The test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other clinical management decisions.

    Device Description

    TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily consists of an FDA 510(k) clearance letter for the TRU FLU device, stating that it is substantially equivalent to legally marketed predicate devices and outlining regulatory requirements. It also includes the official "Indications for Use" statement for the device. Therefore, I cannot fulfill your request based on the provided input.

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