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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.
 
DeviceDAKOCYTOMATION EGFR PHARMDX KIT
Generic NameImmunohistochemistry assay, antibody, epidermal growth factor receptor
Regulation Number864.1860
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara, CA 95051
PMA NumberP030044
Supplement NumberS001
Date Received11/17/2005
Decision Date02/01/2006
Withdrawal Date04/11/2024
Product Code NQF 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL LABELING CHANGES INCLUDE A CLARIFICATION IN THE DEFINITION OF POSITIVE STAINING FOR INDIVIDUAL TUMOR CELLS, INCLUSION OF LIMITATION ABOUT CETUXIMAB RESPONSE RATE FOR NEGATIVE/ POSITIVE PATIENTS AND PERFORMANCE INDICES FOR PATIENTS WHO HAD <1% POSITIVE TUMOR CELLS FOR EGFR.
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