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 |