BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cancer-Related Germline Gene Mutation Detection System

    PMA: P190014 · Supplement: S005 · Decision Jun 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Cancer-Related Germline Gene Mutation Detection System
    Trade Name
    myChoice HRD CDx
    PMA Number
    P190014
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    PJG
    Generic Name
    Cancer-related germline gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 24, 2021
    Date Received
    May 28, 2021
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an update to the contamination detection algorithm which is a quality control change to the myChoice CDx device software.

    Classifications

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

    Product Code Device Name
    PJG Cancer-Related Germline Gene Mutation Detection System