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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namesystem, test, her-2/neu, ihc
Generic Namesystem, test, her-2/neu, ihc
4600 norris canyon rd.
san ramon, CA 94583
PMA NumberP040030
Date Received06/22/2004
Decision Date12/22/2004
Withdrawal Date 03/15/2006
Product Code
MVC[ Registered Establishments with MVC ]
Docket Number 05M-0160
Notice Date 05/02/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the insite her-2/neu kit. The device is indicated for: insite her-2/neu mouse monoclonal antibody (clone cb11) kit is intended for in vitro diagnostic use in immunohistochem-istry (ihc) assays to semi-quantitatively localized by light microscopy the over-expression of her-2/neu (i. E. , c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue sections. Insite her-2/neu is indicated as an aid in the assessment of breast cancer patients for whom herceptin (trastuzumab) therapy is being considered. Clinical interpretation of insite her-2/neu immunostaining results (absence or presence; semi-quantitative intensity score) should be complemented by appropriate controls and morphological tissue analysis and be evaluated by a qualified pathologist within the context of patient clinical history and other diagnostic results.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling