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510(k) Data Aggregation

    K Number
    DEN140044
    Device Name
    23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
    Manufacturer
    23andMe
    Date Cleared
    2015-02-19

    (266 days)

    Product Code
    PKB
    Regulation Number
    866.5940
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    Product Code :

    PKB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 23andMe PGS Carrier Screening Test for Bloom Syndrome is indicated for the detection of the BLMAsh variant in the BLM gene from saliva collected using an FDA cleared collection device (Oragene DX model OGD-500.001). This test can be used to determine carrier status for Bloom syndrome in adults of reproductive age, but cannot determine if a person has two copies of the BLM140 variant. The test is most relevant for people of Ashkenazi Jewish descent.
    Device Description
    The 23andMe Personal Genome Service (PGS) Carrier Screening Test for Bloom Syndrome (hereafter the "PGS") is a non-invasive genetic information service that combines qualitative genotyping data for an individual. The PGS is indicated for use for the detection of the BLM4sh variant in the BLM gene from saliva collected using the Oragene•Dx Saliva Collection Device (Oragene Dx model OGD-500.01). The core components of the PGS consist of the saliva collection kit: custom genotyping chip: laboratory procedures, equipment and analysis; and result reporting software.
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