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510(k) Data Aggregation

    K Number
    K972388
    Device Name
    VISTA ANTIGEN SALMONELLA O GROUP C
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VISTA ANTIGEN SALMONELLA O GROUP C

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

    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for the VISTA™ Antigen Salmonella O Group C device, indicating that the device has been found substantially equivalent to a predicate device.

    The letter does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a study that proves the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
    • Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
    • Details on the type of ground truth used or the sample size and ground truth establishment for a training set.

    The document primarily focuses on the regulatory clearance of the device for its indicated use: "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."

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