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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 HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP990081
Supplement NumberS002
Date Received09/06/2005
Decision Date10/21/2005
Product Code MVC 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF LABELING CHANGES FOR THE PATHWAY HER-2/NEU (CLONE CD11) IN THE "INTENDED USE" SECTION, ADDITION OF AN "OPTIONAL EQUIPMENT NOT PROVIDED" SECTION AND CHANGES TO THE "PRINCIPLES AND PROCEDURES" SECTION TO REFLECT THE ADDITION OF TRIPATH IMAGING VIAS INSTRUMENT TO BE USED IN CONJUNCTION WITH THE VENTANA PATHWAY HER 2 ASSAY AS AN OPTIONAL ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME PATYHWAY HER-2/NEU (CLONE CD11) AND IS INDICATED: VENTANA MEDICAL SYSTEMS, INC.'S (VENTANA) PATHWAY HER 2 (CLONE CD11) IS A MOUSE MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF C-ERBB2- ANTIGEN IN SECTIONS OF FORMALIN FIXED, PARAFFIN EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEM-ISTRY SLIDE STAINING DEVICE. IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN TREATMENT IS CONSIDERED. NOTE: ALL OF THE PATIENTS IN THE HERCEPTIN CLINICAL TRIALS WERE SELECTED USING A CLINICAL TRIAL ASSAY. NONE OF THE PATIENTS IN THOSE TRIALS WERE SELECTED USING PATHWAY HER 2. THE PATHWAY HER 2 WAS COMPARED TO THE DAKO HERCEPTEST ON AN INDEPENDENT SAMPLE AND FOUND TO PROVIDE ACCEPTABLY CONCORDANT RESULTS. THE ACTUAL CORRELATION OF PATHWAY HER 2 TO CLINICAL OUTCOME HAS NOT BEEN ESTABLISHED. THE VENTANA IMAGE ANALYSIS SYSTEM (VIAS) IS ADJUNCTIVE OPTIONAL COMPUTER-ASSISTED IMAGE ANALYSIS SYSTEM FUNCTIONALLY CONNECTED TO AN INTERACTIVE MICROSCOPE. IT IS INTENDED FOR USE AS AN AID TO THE PATHOLOGIST IN THE DETECTION CLASSIFICATION AND COUNTING OF CELLS OF INTEREST BASED ON MARKET INTENSITY, SIZE AND SHAPE USING APPROPRIATE CONTROLS TO ASSURE THE VALIDITY OF THE VIAS SCORES.
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