| Device |
classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer |
| Regulation Description |
Gene expression profiling test system for breast cancer prognosis. |
| Definition |
A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer. The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer. |
| Physical State |
RNA isolation kits, enzymes, fluorescent dyes, hybridization systems, computer |
| Technical Method |
Uses Gene expression and computer algorithm that gives risk of recurrence. Gene expression involves isolation of RNA from frozen tumor tissue sections, amplification of RNA and hybridization. |
| Target Area |
breast tumor tissue sections |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Pathology |
|---|
| Product Code | NYI |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6040
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
