BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P120019 · Decision May 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    COBAS EGFR MUTATION TEST
    PMA Number
    P120019
    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
    May 14, 2013
    Date Received
    November 8, 2012
    Expedited Review
    Y
    Docket Number
    13M-0594

    Advisory Committee Statement

    APPROVAL FOR THE COBAS® EGFR MUTATION TEST. THE COBAS® EGFR MUTATION TEST IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OFTHE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPET) HUMAN NON-SMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED AS AN AID IN SELECTING PATIENTS WITH METASTATIC NSCLC FOR WHOM TARCEVA® (ERLOTINIB), AN EGFR TYROSINE KINASE INHIBITOR (TK1), IS INDICATED. SPECIMENS ARE PROCESSED USING THE COBAS® DNA SAMPLE PREPARATION KIT FOR MANUAL SAMPLE PREPARATION AND THE COBAS Z 480 ANALYZER 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