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    K Number
    K964887
    Device Name
    VIDAS C. DIFFICILE TOXIN A II ASSAY
    Manufacturer
    BIOMERIEUX VITEK, INC.
    Date Cleared
    1997-04-08

    (123 days)

    Product Code
    LLH
    Regulation Number
    866.2660
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VIDAS C. DIFFICILE TOXIN A II ASSAY

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

    The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A. It is substantially equivalent to the Meridian Premier C. difficile Toxin A test as an aid in the diagnosis of Clostridium difficile associated disease (CDAD).

    Device Description

    The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the VIDAS C. difficile Toxin A II assay, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific MetricAcceptance Criteria (Implied/Expected)Reported Device Performance
    False Positive ResultsSpecificityHigh (e.g., >95%)99.1%
    False Negative ResultsSensitivityHigh (e.g., >90%)94.9%
    Equivocal ResultsOccurrenceLow (e.g.,
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