Device |
cancer-related germline gene mutation detection system |
Definition |
The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens. |
Physical State |
Test consists of reagents, instrumentation, software and instructions needed to perform the test method. |
Technical Method |
In vitro amplification and detection of genomic DNA representing a cancer-related germline gene mutation from a clinical specimen of interest |
Target Area |
Human peripheral whole blood or clinical samples |
Review Panel |
Pathology |
Product Code | PJG |
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 |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |