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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesystem, test, her-2/neu, ihc
Generic Namesystem, test, her-2/neu, ihc
Leica Biosystems
36 cherry hill drive
danvers, MA 01923
PMA NumberP090015
Date Received07/22/2009
Decision Date04/18/2012
Product Code
MVC[ Registered Establishments with 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: S001 S002 S003