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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceINSITE HER-2/NEU KIT
Classification Namesystem, test, her-2/neu, ihc
Generic Namesystem, test, her-2/neu, ihc
Applicant
BIOGENEX LABORATORIES, INC.
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
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