BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Xpert C. difficile/Epi

    K Number: K243730 · Decision Feb 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    16
    Applicant Total
    10
    Review Days
    87

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Xpert C. difficile/Epi
    K Number
    K243730
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3130
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cepheid®
    Date Received
    December 3, 2024
    Decision Date
    February 28, 2025
    Product Code
    OZN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OZN C. Difficile Toxin Gene Amplification Assay

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OZN), ordered by most recent decision date.

    Great Basin Toxigenic C. difficile Direct Test (CDF2)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas Cdiff nucleic acid test for use on the cobas Liat System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas Cdiff nucleic acid test for use on the cobas Liat System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GenePOC CDiff

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas Cdiff Nucleic acid test for use on the cobas Liat System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Cepheid®

    K Number Device Name
    K250995 Xpert Xpress CoV-2/Flu/RSV plus
    K250996 Xpert Xpress CoV-2/Flu/RSV plus
    K242109 Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
    K243625 Xpert MRSA/SA SSTI
    K243405 Xpert vanA
    K243070 Xpert® SA Nasal Complete
    K230440 Xpert® Xpress CoV-2 plus
    K231481 Xpert Xpress CoV-2/Flu/RSV plus
    K223046 Xpert® FII & FV