PMA P140025S006
- Device
- VENTANA ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S006
- Product code
- PKW
- Decision date
- 2017-11-06
- Classification
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Approval order statement
- Approval for the VENTANA ALK (D5F3) CDx Assay. The device is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) or ZYKADIA® (ceritinib) or ALECENSA® (alectinib).
Current openFDA PMA Record#
- Device
- VENTANA ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S006
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2017-11-06
- Decision code
- APPR
- Date received
- 2017-06-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the VENTANA ALK (D5F3) CDx Assay. The device is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) or ZYKADIA® (ceritinib) or ALECENSA® (alectinib).