BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P140023 · Decision May 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    COBAS KRAS MUTATION TEST
    PMA Number
    P140023
    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 7, 2015
    Date Received
    October 23, 2014
    Expedited Review
    N
    Docket Number
    15M-1708

    Advisory Committee Statement

    APPROVAL FOR THE COBAS KRAS MUTATION TEST. THIS DEVICE IS INDICATED FOR THE FOLLOWING:THE COBAS KRAS MUTATION TEST, FOR USE WITH THE COBAS 4800 SYSTEM, IS A REAL-TIME PCR TEST FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN CODONS 12 AND 13 OF THE KRAS GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED HUMAN COLORECTAL CANCER (CRC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED AS AN AID IN THE IDENTIFICATION OF CRC PATIENTS FOR WHOM TREATMENT WITH ERBITUX (CETUXIMAB) OR WITH VECTIBIX (PANITUMUMAB) MAY BE INDICATED BASED ON A NO MUTATION DETECTED RESULT.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