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U.S. Department of Health and Human Services

Product Classification

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Device genetic variant detection and health risk assessment system
Regulation Description Genetic health risk assessment system.
Definition A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lifestyle choices and/or encourage conversations with a healthcare professional. This assessment system is for over-the-counter use. This device does not determine the person’s overall risk of developing a disease.
Physical State Qualitative in vitro molecular diagnostic system used to detect variants in genomic DNA from human specimens. System accessory includes collection device for human specimen.
Technical Method Qualitative in vitro molecular diagnostic system used to detect variants in genomic DNA isolated from human specimens. Genetic risk assessment of developing a disease is based on scientifically established disease-risk association for each variant.
Target Area Human specimens collected by the user.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePTA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 866.5950
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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