| Device |
high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids |
| Definition |
A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product. |
| Physical State |
The test may include specimen handling, nucleic acid purification methods, library preparation, target enrichment, and sequencing reagents, instrument systems and software. Should not include devices intended to aid in the diagnosis, prognosis, screening of cancer, or make or recommend treatment decisions. |
| Technical Method |
The test system uses high throughput sequencing technology, including molecular reagents for library preparation, target enrichment, and sequencing, sequencing instrumentation and bioinformatics software, to detect variants in cell free nucleic acids isolated from peripheral whole blood in specified genes associated with malignant neoplasms. |
| Target Area |
Human peripheral whole blood specimens |
| Regulation Medical Specialty |
Pathology |
| Review Panel |
Pathology |
|---|
| Product Code | SBY |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6085
|
|---|
| 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 |
