BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

    K Number: K223597 · Decision Aug 31, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    272

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    Basic Information

    Device Name
    23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
    K Number
    K223597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6090
    Medical Specialty
    Medical Genetics
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    23AndMe, Inc.
    Date Received
    December 2, 2022
    Decision Date
    August 31, 2023
    Product Code
    QAZ
    Advisory Committee
    Medical Genetics
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QAZ Cancer Predisposition Risk Assessment System

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    23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

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    Other Clearances by 23AndMe, Inc.

    K Number Device Name
    K221885 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
    K211499 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
    K193492 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
    K182784 MUTYH-Associated Polyposis (MAP)
    DEN180028 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
    DEN170046 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
    DEN160026 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia