Approval for adding a new therapy vectibix (panitumumab) to intended use. The device, as modified, will be marketed under the trade name dako egfr pharmdx kit and is indicated for: the egfr pharmdx assay is a qualitative immunohistochemical (ihc) kit system to identify epidermal growth factor receptor (egfr) expression in normal and neoplatic tissues routinely-fixed for histological evaluatin. Egfr pharmdx specifically detects the egfr (her1) protein in egfr-expressing cells. Egfr pharmdx is indicated as an aid in identifying colorectal cancer patients eligible for treatment with erbitux (cetuximab), or vectibix (panitumumab).
| Device | DAKO EGFR PHARMDX KIT |
| Classification Name | Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor |
| Generic Name | Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor |
| Applicant | DAKO NORTH AMERICA, INC. |
| Date Received | 2006-04-03 |
| Decision Date | 2006-09-27 |
| PMA | P030044 |
| Supplement | S002 |
| Product Code | NQF |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030044 | | Original Filing |
| S007 |
2019-02-15 |
30-day Notice |
| S006 |
2018-12-21 |
30-day Notice |
| S005 |
2018-03-12 |
30-day Notice |
| S004 |
2017-12-26 |
30-day Notice |
| S003 |
2017-04-17 |
30-day Notice |
| S002 |
2006-04-03 |
Normal 180 Day Track |
| S001 |
2005-11-17 |
Real-time Process |
NIH GUDID Devices