Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Trade Name
- VENTANA ALK (D5F3) CDx Assay
- PMA Number
- P140025
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- PKW
- Generic Name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 3, 2021
- Date Received
- November 16, 2020
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PKW | Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase | FDA class 3 | Unknown |