BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P120022 · Supplement: S002 · Decision Dec 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    THERASCREEN EGFR RGQ PCR KIT
    PMA Number
    P120022
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    OWD
    Generic Name
    Somatic gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 19, 2014
    Date Received
    November 19, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE MANUFACTURING METHOD OF THE POSITIVE CONTROL (PC) IN THE EGFR RGQ PCR KIT. THE CHANGE IN MANUFACTURING METHOD INCLUDES AN ADJUSTMENT STEP OF AN IN-PROCESS PROCEDURE TO ENSURE THAT TARGETED AMOUNTS OF EACH OLIGONUCLEOTIDE WITHIN THE PC ARE CALCULATED TO ACHIEVE THE TARGET CROSSING THRESHOLD (CT).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OWD Somatic Gene Mutation Detection System