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510(k) Data Aggregation

    K Number
    K020689
    Device Name
    SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
    Manufacturer
    MIDI, INC.
    Date Cleared
    2002-10-31

    (241 days)

    Product Code
    NJO
    Regulation Number
    866.3370
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    K020689

    Trade/Device Name: MIDI Sherlock® Mycobacteria Identification System Regulation Number: 21 CFR 866.3370

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

    The MIDI Sherlock® Mycobacteria Identification System is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with Sherlock® pattern recognition software.

    The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques. Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with the MIDI Sherlock® Mycobacteria Identification System device. Results should be interpreted in conjunction with other laboratory observations and procedures.

    Device Description

    The MIDI Sherlock® Mycobacteria Identification System is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with Sherlock® pattern recognition software.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets them. The text is a 510(k) clearance letter for the MIDI Sherlock® Mycobacteria Identification System, which details the FDA's decision regarding its substantial equivalence to a predicate device and its intended use. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

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