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 her2 cish pharmdx kit. This device is indicated tor;her2 cish pharmdx kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the her2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine her2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The cish procedure is automated using dako autoslainerinstruments. Her2 cish pharmdx kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered. Results from the her2 cish pharmdx kit are intended for use as an adjunct to the clinicopathologic informationcurrently used for estimating prognosis in stage ii, node-positive breast cancer patients.
| Device | HER2 CISH PHARMDX KIT |
| Generic Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2010-06-21 |
| Decision Date | 2011-11-30 |
| Notice Date | 2011-12-09 |
| PMA | P100024 |
| Supplement | S |
| Product Code | NYQ |
| Docket Number | 11M-0866 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | DAKO DENMARK A/S 42 Produktionsvej dk-2600 glostrup DK-26-2600 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100024 | Original Filing | |
| S013 | 2017-03-13 | 30-day Notice |
| S012 | 2017-03-13 | 30-day Notice |
| S011 | 2016-12-27 | Real-time Process |
| S010 | 2016-07-01 | Real-time Process |
| S009 | 2016-03-16 | 30-day Notice |
| S008 | 2016-01-08 | 30-day Notice |
| S007 | 2015-08-13 | 30-day Notice |
| S006 | 2014-12-03 | 30-day Notice |
| S005 | 2013-08-01 | 30-day Notice |
| S004 | 2012-11-16 | Normal 180 Day Track |
| S003 | 2012-09-20 | Real-time Process |
| S002 | 2012-07-11 | 30-day Notice |
| S001 | 2011-12-07 | Real-time Process |