PMA P030044S002
- Device
- DAKO EGFR PHARMDX KIT
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P030044
- Supplement
- S002
- Product code
- NQF
- Decision date
- 2006-09-27
- Classification
- Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
- Generic name
- Immunohistochemistry assay, antibody, epidermal growth factor receptor
- 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).
Current openFDA PMA Record#
- Device
- DAKO EGFR PHARMDX KIT
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P030044
- Supplement
- S002
- Product code
- NQF
- Generic name
- Immunohistochemistry assay, antibody, epidermal growth factor receptor
- Decision date
- 2006-09-27
- Decision code
- APPR
- Date received
- 2006-04-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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).