This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the top2a fish pharmdx kit. The device is indicated for: top2a fish pharmdx kit is designed to detect amplifications and deletions (copy number changes) of the top2a gene using fluorescence in situ hybridization (fish) technique on formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Deletions and amplifications of the top2a gene serve as a marker for poor prognosis in high-risk breast cancer patients. Results from the top2a fish pharmdx kit are intended for use as an adjunct to existing clinical and pathological information.
| Device | DAKO TOP2A FISH PHARMDX KIT |
| Generic Name | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2005-11-30 |
| Decision Date | 2008-01-11 |
| Notice Date | 2008-03-20 |
| PMA | P050045 |
| Supplement | S |
| Product Code | NXG |
| Docket Number | 08M-0182 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO DENMARK A/S 42 Produktionsvej 2600 Glostrup DK-26-2600 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050045 | Original Filing | |
| S004 | 2011-12-23 | 135 Review Track For 30-day Notice |
| S003 | 2011-10-06 | 30-day Notice |
| S002 | 2008-03-06 | 30-day Notice |
| S001 | 2008-01-28 | Real-time Process |