Approval for the her2 fish pharmdx kit. The device is indicated for in vitro diagnostic use. The her2 fish pharmdx kit is a direct fluorescence in situ hybridization (fish) assay designed to quantitatively determine her2 gene amplification in formalin-fixed, paraffin-embedded (ffpe) breast cancer tissue specimens and ffpe specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Her2 fish pharmdx kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert).
| Device | HER2 FISH PHARMDX KIT |
| Classification Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Generic Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2010-04-20 |
| Decision Date | 2010-10-20 |
| Notice Date | 2010-11-18 |
| PMA | P040005 |
| Supplement | S005 |
| Product Code | MVD |
| Docket Number | 10M-0558 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Expedited Review | No |
| Combination Product | Yes |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040005 | | Original Filing |
| S014 |
2017-03-13 |
30-day Notice |
| S013 |
2016-03-16 |
30-day Notice |
| S012 |
2016-01-08 |
30-day Notice |
| S011 |
2015-08-13 |
30-day Notice |
| S010 |
2013-08-01 |
30-day Notice |
| S009 |
2012-08-24 |
Normal 180 Day Track |
| S008 |
2012-07-11 |
30-day Notice |
| S007 |
2011-12-14 |
Normal 180 Day Track |
| S006 |
2011-12-05 |
Normal 180 Day Track |
| S005 |
2010-04-20 |
Panel Track |
| S004 |
2010-03-10 |
135 Review Track For 30-day Notice |
| S003 |
2008-07-10 |
Real-time Process |
| S002 |
2007-10-29 |
Real-time Process |
| S001 |
2005-08-15 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices