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 |
Division of Molecular Genetics and Pathology
(DMGP)
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
|