|
Device | DAKOCYTOMATION 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 |
PMA Number | P030044 |
Supplement Number | S001 |
Date Received | 11/17/2005 |
Decision Date | 02/01/2006 |
Withdrawal Date
|
04/11/2024 |
Product Code |
NQF |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |