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

    Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

    K Number: K250249 · Decision Oct 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    256

    Basic Information

    Device Name
    Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
    K Number
    K250249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3820
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gold Standard Diagnostics, LLC
    Date Received
    January 27, 2025
    Decision Date
    October 10, 2025
    Product Code
    GMQ
    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
    GMQ Antigens, Nontreponemal, All

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