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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
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)
Regulation Number 866.5950
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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