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510(k) Data Aggregation

    K Number
    K241456
    Device Name
    GlutenID Celiac Genetic Health Risk Test
    Manufacturer
    Targeted Genomics, LLC
    Date Cleared
    2025-01-07

    (230 days)

    Product Code
    PTA
    Regulation Number
    866.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Targeted Genomics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlutenID Celiac Genetic Health Risk Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from salva collected from individuals 18 years of age or older with ORAcollect Dx OCD-100 for the purpose of reporting and interpreting Genetic Health Risks (GHR). The GlutenID Celiac GHR Test is indicated for reporting of one variant associated with the HLA-DQ2.5 haplotype, one variant associated with the HLA-DQ8 haplotype, one variant associated with the HLA-DQ7 haplotype, and three variants associated with the HLA-DQ2.2 haplotype. The report describes if a person has variants linked to haplotypes associated with an increased risk for developing celiac disease, but it does not describe a person's overall risk of developing celiac disease. This report is most relevant for people of European descent.
    Device Description
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