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510(k) Data Aggregation

    K Number
    K052485
    Device Name
    SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
    Manufacturer
    MIDI, INC.
    Date Cleared
    2006-01-17

    (130 days)

    Product Code
    NWZ,KZQ,NPO
    Regulation Number
    866.3045
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MIDI Sherlock Microbial Identification System for BioDef™ is intended to aid in the identification of Bacillus anthracis through the analysis of membrane fatty acids derived from cultured bacterial samples, using gas chromatography and pattern recognition software.

    Device Description

    Not Found

    AI/ML Overview

    The provided document does not contain information about the acceptance criteria and the study that proves the MIDI Sherlock Microbial Identification System BioDef™ meets these criteria. The document is an FDA 510(k) clearance letter confirming substantial equivalence to a predicate device and provides "Indications for Use" for the device, along with some warnings.

    Therefore, I cannot provide the requested information.

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    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
    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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