| Device |
tumor gene profiling test |
| Definition |
A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from nucleic acids isolated from human clinical specimens obtained from patients diagnosed with malignant neoplasms using targeted next-generation sequencing. |
| Physical State |
The device may include specimen handling, nucleic acid purification methods, specialized molecular reagents for target enrichment, library preparation and sequencing reagents, instrument systems and software. May also include algorithms based on sequencing results for the purpose of deriving a clinical decision point for a qualitative result output. Should not include devices intended for re-importation. |
| Technical Method |
The device utilizes high throughput, massively parallel targeted sequencing including molecular reagents for target enrichment, library preparation, and sequencing using multiplexed polymerase chain reactions, sequencing instrumentation, and bioinformatics software. May also include algorithms based on sequencing results for the purpose of deriving a clinical decision point for a qualitative result output. |
| Target Area |
Nucleic acids isolated from human clinical specimens [e.g., cell free, circulating tumor DNA (ctDNA) from human plasma, DNA isolated from formalin-fixed, paraffin-embedded tumor tissue, etc.] and matched normal tissue or peripheral whole blood. |
| Review Panel |
Pathology |
|---|
| Product Code | QFK |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
|
Not Classified Reason
|
For Export Only
|
|---|
| Submission Type |
Contact ODE
|
|---|
| Device Class |
Not Classified
|
| 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 |
