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510(k) Data Aggregation

    K Number
    K143288
    Device Name
    Sensititre Susceptibility plates
    Manufacturer
    THERMO FISHER SCIENTIFIC
    Date Cleared
    2015-04-01

    (135 days)

    Product Code
    JWY,LRG,LTT,LTW
    Regulation Number
    866.1640
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(k) is for the newly approved Oritavancin in the dilution range of 0.0005-8 ug/ml for testing non-fastidious gram positive organisms on the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin susceptible (MSSA) isolates) Enterococcus faecalis(vancomycin-susceptible isolates only)

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Oritavancin. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information based on the given input. The document primarily focuses on regulatory clearance and indications for use.

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