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510(k) Data Aggregation

    K Number
    K172542
    Device Name
    Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2017-10-23

    (61 days)

    Product Code
    JWY
    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 Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

    The Tedizolid MTS at concentrations of 0.002- 32 ug/mL should be interpreted at 16-20 hours of incubation for nonfastidious organisms and 20-24 hours for fastidious organisms.

    Tedizolid has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA drug label:

    Staphylococcus aureus (including methicillin resistant and methicillin susceptible isolates) Enterococcus faecalis

    Tedizolid has been shown to be active both climically and in vitro against the fastidious bacteria listed below according to the FDA drug label:

    Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. constellatus, S. intermedius)

    Device Description

    MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA regarding a medical device, the Liofilchem MIC Test Strip (MTS) - Tedizolid. It does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device's performance study.

    The document primarily provides the FDA's decision of substantial equivalence for the device, its intended use, and regulatory information. It confirms the device is substantially equivalent to legally marketed predicate devices for determining antimicrobial susceptibility.

    Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets those criteria based on the provided text. The document is a regulatory approval letter, not a study report.

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