| Device |
next generation sequencing based tumor profiling test |
| Regulation Description |
Next generation sequencing based tumor 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 tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing. |
| Physical State |
The test may also include specimen handling, nucleic acid purification methods, target enrichment, library preparation and sequencing reagents, instrument systems and software. |
| Technical Method |
High throughput, massive 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 unique algorithms based on sequencing results for the purpose of deriving a clinical decision point for a qualitative result output. |
| Target Area |
Human tumor tissue specimens and matched normal tissue or matched peripheral whole blood. |
| Regulation Medical Specialty |
Pathology |
| Review Panel |
Pathology |
|---|
| Product Code | PZM |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6080
|
|---|
| Device Class |
2
|
| 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
|
Accredited Persons
|
