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510(k) Data Aggregation

    K Number
    K191931
    Device Name
    HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
    Manufacturer
    Hardy Diagnostics
    Date Cleared
    2019-07-31

    (12 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This FDA document is a 510(k) clearance letter for an antimicrobial susceptibility test disc. It does not contain the kind of detailed information typically found in a study report for AI/ML-based medical devices regarding acceptance criteria, performance tables, sample sizes, ground truth establishment, or expert adjudication.

    Therefore, I cannot extract the requested information from the provided text. The document confirms that the HardyDisk AST Imipenem/relebactam 10/25ug (IMR 10/25) device, a physical test disc, has been found substantially equivalent to a predicate device. It does not describe a study involving an algorithm or AI.

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