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 bond oracle her2 ihc system. This device is indicated for: bond oracle her2 ihc system is a semi-quantitative immunohistochemical (ihc) assay to determine her2 (human epidermal growth factor receptor 2) oncoprotein status in formalin-fixed, parrafin embedded breast cancer tissue processed for histological evaluation following automated staining on the bond-max slide staining instrument. The bond oracle her2 ihc system is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered.
| Device | BOND ORACLE HER2 IHC SYSTEM |
| Classification Name | System, Test, Her-2/neu, Ihc |
| Generic Name | System, Test, Her-2/neu, Ihc |
| Applicant | Leica Biosystems |
| Date Received | 2009-07-22 |
| Decision Date | 2012-04-18 |
| Notice Date | 2012-04-25 |
| PMA | P090015 |
| Supplement | S |
| Product Code | MVC |
| Docket Number | 12M-0390 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Leica Biosystems 36 Cherry Hill Drive danvers, MA 01923 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090015 | Original Filing | |
| S012 | 2020-08-28 | 30-day Notice |
| S011 | 2020-04-02 | 30-day Notice |
| S010 | 2019-12-13 | 30-day Notice |
| S009 | 2019-09-09 | 30-day Notice |
| S008 | 2019-07-24 | 30-day Notice |
| S007 | 2019-04-01 | 30-day Notice |
| S006 | 2018-10-26 | Real-time Process |
| S005 | 2017-06-27 | 30-day Notice |
| S004 | 2017-02-02 | 30-day Notice |
| S003 | 2015-04-20 | Special (immediate Track) |
| S002 | 2014-11-28 | Real-time Process |
| S001 | 2013-07-26 | Normal 180 Day Track |