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510(k) Data Aggregation

    K Number
    K123418
    Device Name
    GRAM-NEGATIVE QUICKFISH BC
    Manufacturer
    ADVANDX, INC.
    Date Cleared
    2013-07-21

    (257 days)

    Product Code
    JSS
    Regulation Number
    866.2660
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GRAM-NEGATIVE QUICKFISH BC

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the "Gram-Negative QuickFISH™ BC Blood Culture Identification Kit." This letter grants market clearance based on substantial equivalence to a predicate device, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in the 510(k) submission itself.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, ground truth methods), or the specifics of standalone or MRMC studies from this document.

    To answer your questions, I would need access to the actual 510(k) submission for K123418, which would include the clinical and analytical study reports.

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