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U.S. Department of Health and Human Services

Product Classification

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Device next generation sequencing oncology panel, somatic or germline variant detection system
Definition A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.
Physical State Multiplex, high-throughput next generation sequencing-based test system. The device may include hybridization- or amplification-based capture methods for library construction. Test consists of reagents, instrumentation, software, and instructions needed to perform the test method.
Technical Method The assay uses next generation sequencing technology to sequence and identify nucleic acid variants located in specified genes associated with clinical cancer specimens. Variants are identified by comparison to a specified reference sequence.
Target Area Human clinical specimens
Review Panel Pathology
Product CodePQP
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible