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U.S. Department of Health and Human Services

Product Classification

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Device direct-to-consumer access pharmacogenetic assessment system
Definition A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users.
Physical State The test system includes reagents and instrumentation for measuring and analyzing nucleic acid sequences and methods for interpretation of the pharmacogenetic associations for detected nucleic acid sequence variations. The test system provides information on the pharmacogenetic associates for the detected variants in lay-user reports.
Technical Method Measures and analyzes nucleic acid sequences and interprets pharmacogenetic associations for detected nucleic acid sequence variations.
Target Area Sample collection device, molecular diagnostic test
Regulation Medical Specialty Molecular Genetics
Review Panel Clinical Chemistry
Product CodeQDJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3364
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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