| Device |
automated digital image manual interpretation microscope |
| Regulation Description |
Immunohistochemistry reagents and kits. |
| Definition |
The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for her-2 receptors, using microscopy images displayed on a computer monitor. Her-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes in breast cancer. |
| Physical State |
automated digital microscope slide scanner, computer, color monitor, keyboard and digital pathology information management software |
| Technical Method |
Digital microscopy image of stained tissue on a microscope slide, used to determine HER2 IHC status |
| Target Area |
Immunohistochemical stained microscope slides |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Pathology |
|---|
| Product Code | OEO |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.1860
|
|---|
| 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
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
