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. |
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Device | DAKO EGFR PHARMDX KIT |
Generic Name | immunohistochemistry assay, antibody, epidermal growth factor receptor |
Regulation Number | 864.1860 |
Applicant |
Agilent Technologies, Inc. |
5301 stevens creek blvd. |
santa clara, CA 95051 |
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PMA Number | P030044 |
Supplement Number | S002 |
Date Received | 04/03/2006 |
Decision Date | 09/27/2006 |
Product Code |
NQF
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Advisory Committee |
Pathology |
Supplement Type | normal 180 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
No
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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). |
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