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U.S. Department of Health and Human Services

Product Classification

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Device cancer predisposition risk assessment system
Definition A qualitative in vitro molecular diagnostic system used for the detection of select variants in specified cancer-related genes. The device is intended to be used on genomic DNA isolated from human specimens collected by the user. The results of the test provide users with a genetic health risk assessment for developing certain cancers. The test may not include all variants associated with a predisposition of developing cancer and is not intended to describe a person’s overall risk of developing any type of cancer nor to aid in determination of treatment or act as a substitute for recommended cancer screenings or appropriate follow-up. The device is for over-the-counter use.
Physical State The test system consists of reagents, instrumentation, software, and instructions needed to understand the test report. The test system includes a collection device, instructions for collecting the specimen, and a pre-addressed shipping label and materials is provided separately to the customer. Should not include tests intended for prescription use, intended to aid in diagnosis or prognosis of cancer, or intended to make or recommend treatment decisions.
Technical Method The test system uses multiplex technology to amplify, detect, and identify nucleic acid variants located in specified genes associated with hereditary cancer risk. Variants are identified by comparison to a specified reference sequence, and genetic risk assessment of developing certain cancers is based on scientifically established disease-risk association for each variant. The test is intended to be used as a direct-to-consumer, over-the-counter genomic DNA testing service.
Target Area Human clinical specimens (e.g., saliva) collected by the user/customer.
Regulation Medical Specialty Molecular Genetics
Review Panel Pathology
Product CodeQAZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.6090
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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