BEUDAMED
    Product Code: PKB FDA class 2 21 CFR 866.5940

    Autosomal Recessive Carrier Screening Gene Mutation Detection System

    Immunology

    The Autosomal Recessive Carrier Screening Gene Mutation Detection System is a qualitative in vitro molecular diagnostic device used for genotyping of clinically relevant variants in genomic DNA from peripheral whole blood or saliva, intended for autosomal recessive disease carrier screening in adults of reproductive age, available for prescription or over-the-counter use. It is an FDA Class 2 device regulated under 21 CFR 866.5940, requiring 510(k) premarket notification, within the Immunology (IM) specialty with Pathology (PA) panel review. The product code is PKB. The device is not intended for copy number variation, cytogenetic, or biochemical testing.

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    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    PKB
    Device Class
    FDA class 2
    Regulation Number
    866.5940
    Medical Specialty
    Immunology
    Review Panel
    PA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN140044 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.