BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P120022 · Supplement: S001 · Decision Jul 10, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    THERASCEEN EGFR RGQ PCR KIT
    PMA Number
    P120022
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    OWD
    Generic Name
    Somatic gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 10, 2015
    Date Received
    September 18, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXTENDING THE LABEL CLAIM OF THE THERASCREEN® EGFR RGQ PCR KIT TO INCLUDE AN INDICATION FOR IRESSA (GEFITINIB). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERASCREEN® EGFR RGQ PCR KIT AND IS INDICATED FOR:THE THERASCREEN® EGFR RGQ PCR KIT IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED TO SELECT PATIENTS WITH NSCLC FOR WHOM GILOTRIF (AFATINIB) OR IRESSA (GEFITINIB), EGFR TYROSINE KINASE INHIBITORS (TKIS), IS INDICATED. SAFETY AND EFFICACY OF GILOTRIF (AFATINIB) AND IRESSA (GEFITINIB) HAVE NOT BEEN ESTABLISHED IN THE PATIENTS WHOSE TUMORS HAVE L861Q, G719X, S768I, EXON 20 INSERTIONS, AND T790M MUTATIONS, WHICH ARE ALSO DETECTED BY THE THERASCREEN EGFR RGQ PCR KIT.SPECIMENS ARE PROCESSED USING THE QIAAMP DSP DNA FFPE TISSUE KIT FOR MANUAL SAMPLE PREPARATION AND THE ROTOR-GENE Q MDX INSTRUMENT FOR AUTOMATED AMPLIFICATION AND DETECTION.

    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