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510(k) Data Aggregation

    K Number
    K974881
    Device Name
    TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
    Manufacturer
    BIOSITE INCORPORATED
    Date Cleared
    1998-03-20

    (80 days)

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

    TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A

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

    The Triage® C. difficile test is an enzyme immunoassay used for the detection of Clostridium difficile antigen (glutamate dehydrogenase or common antigen) and Toxin A in human fecal specimens. The test will be offered as two singular tests for each protein. This test is used as an aid in the diagnosis of C. difficile associated disease.

    Device Description

    The Triage® C. difficile test is an enzyme immunoassay.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the Triage® C difficile Panel. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, study details, or performance data for the device.

    Therefore, I cannot provide the requested information based on the given text. The letter only acknowledges the device's clearance for marketing.

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