BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P120019 · Supplement: S007 · Decision Nov 13, 2015
    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 V2
    PMA Number
    P120019
    Supplement Number
    S007
    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
    November 13, 2015
    Date Received
    May 28, 2015
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    Y
    Docket Number
    15M-4344

    Advisory Committee Statement

    APPROVAL FOR THE COBAS® EGFR MUTATION TEST V2. THIS DEVICE IS INDICATED FOR:THE COBAS® EGFR MUTATION TEST V2 IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF DEFINED MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED TUMOR TISSUE (FFPET) FROM NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. THE TEST IS INTENDED TO AID IN IDENTIFYING PATIENTS WITH NSCLC WHOSE TUMORS HAVE DEFINED EGFR MUTATIONS AND FOR WHOM SAFETY AND EFFICACY OF A DRUG HAVE BEEN ESTABLISHED AS FOLLOWS: TARCEVA® (ERLOTINIB)/EXON 19 DELETIONS AND L858R AND TAGRISSO® (OSIMERTINIB) T790M. DRUG SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING EGFR MUTATIONS ALSO DETECTED BY THE COBAS® EGFR MUTATION TEST V2: TARCEVA® (ERLOTINIB)/G719X, EXON 20 INSERTIONS, T790M, S768I AND L861Q/TAGRISSO® (OSIMERTINIB)/G719X, EXON 19 DELETIONS, L858R, EXON 20 INSERTIONS, S768I, AND L861Q. FOR MANUAL SAMPLE PREPARATION, FFPET SPECIMENS ARE PROCESSED USING THE COBAS® DNA SAMPLE PREPARATION KIT AND THE COBAS Z 480 ANALYZER IS USED 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