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510(k) Data Aggregation

    K Number
    K973489
    Device Name
    LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1997-10-10

    (25 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

    Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus spp.

    Device Description

    Oxoid Loracarbef Susceptibility Test Disc

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device (Loracarbef Antimicrobial Susceptibility Test Disc), and as such, it confirms the substantial equivalence of the device to a predicate device but does not detail the specific performance acceptance criteria or the study data used to demonstrate them. The letter mentions the "indications for use" but does not provide performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies.

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