Approval for the herceptest kit. The device is indicated for in vitro diagnostic use. Herceptest is a semi-quantitative immunocytochemi-cal 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 patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert).
| Device | HERCEPTEST |
| Classification Name | System, Test, Her-2/neu, Ihc |
| Generic Name | System, Test, Her-2/neu, Ihc |
| Applicant | DAKO A/S |
| Date Received | 2010-04-21 |
| Decision Date | 2010-10-20 |
| Notice Date | 2010-11-17 |
| PMA | P980018 |
| Supplement | S010 |
| Product Code | MVC |
| Docket Number | 10M-0557 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | DAKO A/S 42 Produktionsvej glostrup DK-26-2600 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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