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510(k) Data Aggregation

    K Number
    K973457
    Device Name
    CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
    Manufacturer
    SHARED SYSTEMS, INC.
    Date Cleared
    1998-01-02

    (112 days)

    Product Code
    GMZ
    Regulation Number
    866.3255
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHARED SYSTEMS, INC.

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

    The E. coli 0157 Latex Agglutination Test is a rapid test for E. coli serogroup 0157 detection in all primary cultures suspected to be E. coli spp.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but this document is an FDA communication regarding a 510(k) submission for the Chromalex E. coli O157 Latex Agglutination Test System. It confirms the device's substantial equivalence to a predicate device and allows it to be marketed.

    However, the document does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications for performance evaluation. Such information would typically be found in the 510(k) submission itself or in a separate performance study report, neither of which is provided here.

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