Approval for addition of pertuzumab in the labeling of her2 fish pharmdx kit. The device, as modified, will be marketed under the trade name her2 fish pharmdx kit and its indication for use is: a direct fluorescence in situ hybridization (fish) assay designed toquantitatively 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 breast and gastric cancer patients for whom herceptin (trastuzumab) treatment is being considered and for breast cancer patients for whom perjeta (pertuzumab) treatment is being considered (see herceptin and perjeta package inserts).
| Device | HER2 FISH PHARMADX 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 | 2011-12-05 |
| Decision Date | 2012-06-08 |
| PMA | P040005 |
| Supplement | S006 |
| Product Code | MVD |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | DAKO DENMARK A/S 42 Produktionsvej 2600 Glostrup DK-26-2600 |
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