- Device
- VENTANA ALK (D5F3) CDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P140025
- Supplement
- S014
- Product code
- PKW
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Decision date
- 2021-03-03
- Decision code
- APPR
- Date received
- 2020-11-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for inclusion of an indication for LORBRENA ((lorlatinib). The device will be marketed under the trade name VENTANA ALK (D5F3) CDx Assay and is indicated for: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 or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), or ALECENSA® (alectinib) or LORBRENA® (lorlatinib).This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This product is intended for in vitro diagnostic (IVD) use.