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510(k) Data Aggregation

    K Number
    K972391
    Device Name
    VISTA ANTIGEN SALMONELLA H B
    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 H B

    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

    This document (K972391) is a 510(k) clearance letter from the FDA for the VISTA™ Antigen Salmonella H b device. It states that the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer your specific questions about the device's technical performance.

    The letter focuses on the regulatory clearance of the device based on substantial equivalence, rather than a detailed technical report of its performance or the clinical study that led to its validation.

    Therefore, I cannot extract the following information from the provided text:

    1. A table of acceptance criteria and the reported device performance: This information is not present in the regulatory clearance letter. The letter acknowledges the device's substantial equivalence but does not detail performance metrics or acceptance criteria.
    2. Sample sizes used for the test set and the data provenance: This information is not provided.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
    4. Adjudication method for the test set: This information is not provided.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not provided.
    6. If a standalone performance study was done: The document doesn't detail the studies performed, but rather the regulatory outcome based on submitted data.
    7. The type of ground truth used: This information is not provided.
    8. The sample size for the training set: This information is not provided.
    9. How the ground truth for the training set was established: This information is not provided.

    The current document is a regulatory approval letter, not a clinical study report. To obtain the information you're asking for, you would typically need to refer to the 510(k) submission summary or the actual studies cited within the submission, which are not part of this letter.

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