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U.S. Department of Health and Human Services

Product Classification
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Device somatic gene mutation detection system
Definition The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.
Physical State Test consists of reagents, instrumentation, software and instructions needed to perform the test method.
Technical Method In vitro amplification and detection of genomic DNA representing a somatic gene mutation from a cancerous specimen of interest.
Target Area Human clinical specimens of peripheral blood or bone marrow.
Review Panel Pathology
Product CodeOWD
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type PMA
Device Class 3
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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