|
Device | BOND ORACLE HER2 IHC SYSTEM |
Generic Name | system, test, her-2/neu, ihc |
Applicant |
Leica Biosystems |
36 cherry hill drive |
danvers, MA 01923 |
|
PMA Number | P090015 |
Date Received | 07/22/2009 |
Decision Date | 04/18/2012 |
Product Code |
MVC
|
Docket Number | 12M-0390 |
Notice Date | 04/25/2012 |
Advisory Committee |
Pathology |
Expedited Review Granted? | No |
Combination Product |
Yes
|
Approval Order Statement
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. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
|
Supplements: |
S004 S003 S002 S001 S011 S010 S009 S012 S008 S007 S005 S006 |