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510(k) Data Aggregation

    K Number
    K152838
    Manufacturer
    Date Cleared
    2015-11-24

    (56 days)

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

    Use of HardyDisk AST Ceftazidime/Avibactam, (30/20ug) - CZA50, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftazidime/Avibactam.

    The concentration of Ceftazidime/Avibactam, (30/20ug) - CZA50, has been shown to be active against susceptible isolates of the following microorganisms with in vitro use: Morganii, Providencia rettgeri, and Serratia marcescens.

    The concentration of Ceftazidime/Avibactam, (30/20ug) - CZA50, has been shown to be active against susceptible isolates of the following microorganisms with both in vitro and in clinical infections: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Citrobacter freundii, Citrobacter koseri, Proteus spp., and Enterobacter aerogenes.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for an antimicrobial susceptibility test disc (Hardydisk AST Ceftazidime/Avibactam). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter acknowledges the clearance of the device based on substantial equivalence to a predicate device, but it does not detail the specific performance metrics or studies performed.

    Therefore, I cannot provide the requested information from the provided text.

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