Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
Device | VENTANA ALK (D5F3) CDX ASSAY |
---|---|
Generic Name | Immunohistochemistry assay, antibody, anaplastic lymphoma kinase |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. TUCSON, AZ 85755 |
PMA Number | P140025 |
Date Received | 11/14/2014 |
Decision Date | 06/12/2015 |
Product Code | PKW |
Docket Number | 15M-2219 |
Notice Date | 07/10/2015 |
Advisory Committee | Pathology |
Clinical Trials | NCT00585195 |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE VENTANA ALK (D5F3) CDX ASSAY. THIS DEVICE IS INDICATED FOR THE FOLLOWING:VENTANA ALK (D5F3) CDX ASSAY 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 AUTOMATED STAINING INSTRUMENT. IT IS INDICATED AS AN AID IN IDENTIFYING PATIENTS ELIGIBLE FOR TREATMENT WITH XALKORI® (CRIZOTINIB). | |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling |
Supplements: | S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S020 S021 S022 S023 |