|
Device | VENTANA ALK (D5F3) CDx Assay |
Classification Name | immunohistochemistry assay, antibody, anaplastic lymphoma kinase |
Generic Name | immunohistochemistry assay, antibody, anaplastic lymphoma kinase |
Applicant |
VENTANA MEDICAL SYSTEMS, INC. |
1910 east innovation park dr. |
tucson, AZ 85755 |
|
PMA Number | P140025 |
Supplement Number | S006 |
Date Received | 06/07/2017 |
Decision Date | 11/06/2017 |
Product Code | |
Advisory Committee |
Pathology |
Clinical Trials |
NCT02075840
|
Supplement Type | normal 180 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
|
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). |