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510(k) Data Aggregation

    K Number
    K030991
    Device Name
    C. DIFF CHEK - 30
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2003-07-11

    (105 days)

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

    C. DIFF CHEK - 30

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

    The C. DIFF CHEK™ - 30 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from non toxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the C. Diff Check™ - 30 device. It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, or performance data for the device.

    Therefore, I cannot provide the requested information. The provided text is a regulatory clearance document, not a clinical study report or performance evaluation.

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