|Trade Name||BOND ORACLE HER2 IHC SYSTEM|
|Classification Name||system, test, her-2/neu, ihc|
|Docket Number|| 12M-0390|
|Notice Date|| 04/25/2012|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|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.