| Device |
high throughput dna sequencing for hereditary cancer predisposition assessment test system. |
| Definition |
A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations in a panel of targeted cancer related genes. It is intended to aid in hereditary cancer predisposition assessment by qualified health care professionals in accordance with professional guidelines. The device is not intended for screening, prenatal testing or as a stand-alone diagnostic test. The device is for prescription use only. |
| Physical State |
The test system consists of reagents, DNA sequencing detection methods, and software. Should not include devices intended for over-the-counter use, intended to aid in diagnosis, prognosis or screening of cancer, pre-natal screening, or intended to make or recommend treatment decisions. |
| Technical Method |
The test system uses high-throughput sequencing technology to amplify, detect, and identify nucleic acid variants located in specified genes associated with hereditary cancer predisposition. Variants are identified based on de novo sequencing or by comparison to a specified reference sequence. The test system may also include confirmatory testing for certain variants. Genetic predisposition assessment of developing certain cancers is based on scientifically established disease-risk association for each variant. |
| Target Area |
Human peripheral whole blood or other clinical samples |
| Regulation Medical Specialty |
Pathology |
| Review Panel |
Pathology |
|---|
| Product Code | QVU |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6095
|
|---|
| 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 |
