Approval for addition of pertuzumab in the labeling of herceptest. Thedevice, as modified, will be marketed under the trade name herceptest and its indication for use is: herceptest is a semi-quantitative immunohisto-chemical assay to determine her2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Herceptest 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 beingconsidered (see herceptin and perjeta package inserts).
| Device | HERCEP TEST |
| Classification Name | System, Test, Her-2/neu, Ihc |
| Generic Name | System, Test, Her-2/neu, Ihc |
| Applicant | DAKO A/S |
| Date Received | 2011-12-05 |
| Decision Date | 2012-06-08 |
| PMA | P980018 |
| Supplement | S015 |
| Product Code | MVC |
| 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 A/S 42 Produktionsvej glostrup DK-26-2600 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980018 | | Original Filing |
| S025 |
2020-06-04 |
30-day Notice |
| S024 |
2018-01-12 |
30-day Notice |
| S023 |
2016-12-27 |
Real-time Process |
| S022 |
2016-06-06 |
Real-time Process |
| S021 |
2016-02-29 |
Real-time Process |
| S020 |
2015-08-13 |
30-day Notice |
| S019 |
2015-04-27 |
30-day Notice |
| S018 |
2013-11-21 |
Special (immediate Track) |
| S017 |
2012-11-01 |
Normal 180 Day Track |
| S016 |
2012-08-24 |
Normal 180 Day Track |
| S015 |
2011-12-05 |
Normal 180 Day Track |
| S014 |
2011-08-15 |
30-day Notice |
| S013 |
2011-04-06 |
Special (immediate Track) |
| S012 |
2011-01-24 |
30-day Notice |
| S011 |
2010-09-09 |
Normal 180 Day Track |
| S010 |
2010-04-21 |
Panel Track |
| S009 |
2010-02-25 |
Real-time Process |
| S008 |
2010-02-12 |
30-day Notice |
| S007 |
2009-12-31 |
30-day Notice |
| S006 |
2008-05-28 |
Normal 180 Day Track |
| S005 |
2005-12-08 |
Special (immediate Track) |
| S004 |
2005-06-20 |
30-day Notice |
| S003 |
2004-11-10 |
Normal 180 Day Track No User Fee |
| S002 |
2003-05-14 |
30-day Notice |
| S001 |
2002-11-15 |
Real-time Process |
NIH GUDID Devices