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510(k) Data Aggregation

    K Number
    K972394

    Validate with FDA (Live)

    Device Name
    VISTA ANTIGEN BRUCELLA ABORTUS
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GSO
    Regulation Number
    866.3085
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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

    This document is an FDA 510(k) clearance letter for the VISTA™ Antigen Brucella abortus device. It does not contain details about acceptance criteria, study design, or performance metrics beyond the statement that the device is "substantially equivalent" to predicate devices.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert qualifications, or ground truth methods from this document. The letter primarily confirms regulatory clearance based on substantial equivalence to existing devices, without detailing the specific performance studies that led to this determination.

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