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 Code | PQP |
Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
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 |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |