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

    23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

    K Number: K221885 · Decision Oct 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    8
    Review Days
    119

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    Basic Information

    Device Name
    23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
    K Number
    K221885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3364
    Medical Specialty
    Medical Genetics
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    23AndMe, Inc.
    Date Received
    June 29, 2022
    Decision Date
    October 26, 2022
    Product Code
    QDJ
    Advisory Committee
    Medical Genetics
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QDJ Direct-To-Consumer Access Pharmacogenetic Assessment System

    Similar 510(k) Clearances

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    Other Clearances by 23AndMe, Inc.

    K Number Device Name
    K223597 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
    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