| 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 |
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 |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
