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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP990081
Supplement NumberS003
Date Received05/04/2006
Decision Date01/11/2007
Product Code MVC 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE PATHWAY C-ERBB-2 PRIMARY ANTIBODY(CLONE CB11) WHICH INCLUDE 1) CHANGE THE PRIMARY ANTIBODY FROM THE MOUSE MONOCLONAL ANTIBODY CB11 TO THE RABBIT MONOCLONAL ANTIBODY 4B5, 2) CHANGE THE DETECTION FORMAT FROM BASIC DAB DETECTION KIT TO THE VENTANA MEDICAL SYSTEMS IVIEW DAB DETECTION KIT, 3) ADD THE OPTIONAL ULTRAVIEW UNIVERSAL DAB DETECTION KIT FOR BIOTIN FREE DETECTION FORMAT, 4) CONSOLIDATE LEVEL 1,3 AND NEGATIVE HER-2 ASSAY CONTROL SLIDES ONTO A SINGLE SLIDE AND ADD A LEVEL 2 ASSAY CONTROL AND THE CONTROL WILL BE MARKETED UNDER THE TRADE NAME OF PATHWAY HER2 4 IN 1 CONTROL SLIDE, AND 5) INCLUDE THE VENTANA IMAGE ANALYSIS SYSTEM (VIAS) IN THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY AND IS INDICATED FOR: VENTANA MEDICAL SYSTEMS, INC.?S (VENTANA) PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY (PATHWAY HER2 (4B5)) IS A RABBIT MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF HER2 ANTIGEN IN SECTIONS OF FORMALIN-FIXED, PARAFFIN-EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEMISTRY SLIDE STAINING DEVICE. IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN TREATMENT IS BEING CONSIDERED.
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