Premarket Approval (PMA)

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.

• Device: DAKO EGFR PHARMDX KIT
• Classification Name: immunohistochemistry assay, antibody, epidermal growth factor receptor
• Generic Name: immunohistochemistry assay, antibody, epidermal growth factor receptor
• Regulation Number: 864.1860
• Applicant: DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria, CA 93013
• PMA Number: P030044
• Supplement Number: S002
• Date Received: 04/03/2006
• Decision Date: 09/27/2006
• Product Code: NQF [ Registered Establishments with NQF ]
• Advisory Committee: Pathology
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications/material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
APPROVAL FOR ADDING A NEW THERAPY VECTIBIX (PANITUMUMAB) TO INTENDED USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DAKO EGFR PHARMDX KIT AND IS INDICATED FOR: THE EGFR PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM TO IDENTIFY EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXPRESSION IN NORMAL AND NEOPLATIC TISSUES ROUTINELY-FIXED FOR HISTOLOGICAL EVALUATIN. EGFR PHARMDX SPECIFICALLY DETECTS THE EGFR (HER1) PROTEIN IN EGFR-EXPRESSING CELLS. EGFR PHARMDX IS INDICATED AS AN AID IN IDENTIFYING COLORECTAL CANCER PATIENTS ELIGIBLE FOR TREATMENT WITH ERBITUX (CETUXIMAB), OR VECTIBIX (PANITUMUMAB).