| Device |
lynch syndrome test system |
| Regulation Description |
Lynch syndrome test systems. |
| Definition |
The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome |
| Physical State |
The test may include detection reagents, instrument systems and software. May also include specimen handling and processing methods |
| Technical Method |
The test uses immunohistochemistry, DNA amplification, or DNA sequencing based methods to identify defects in DNA mismatch repair proteins and/or microsatellite instability in tumor tissue. Deficiencies or defects in DNA mismatch repair proteins and/or microsatellite instability are identified by comparison to a paired normal specimen |
| Target Area |
Human tissue or peripheral blood for normal comparision |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Pathology |
|---|
| Product Code | PZJ |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.1866
|
|---|
| 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 |
Not Third Party Eligible |
