Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
Basic Information
- Device Name
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Trade Name
- Vysis ALK Break Apart Fish Probe Kit
- PMA Number
- P110012
- Supplement Number
- S020
- Device Class
- FDA Class 3
- Product Code
- OWE
- Generic Name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 22, 2020
- Date Received
- December 23, 2019
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval of the expansion of the Indications for Use for the Vysis ALK Break Apart FISH Probe Kit to include an indication for ALUNBRIG® (brigatinib). The device, as modified, will be marketed under the trade name Vysis ALK Break Apart FISH Probe Kit and is indicated for:INTENDED USE The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) tissue specimens from non-small cell lung cancer (NSCLC) patients.INDICATION FOR USEThe Vysis ALK Break Apart FISH Probe Kit is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) and ALUNBRIG® (brigatinib) in accordance with the approved therapeutic product labeling.
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 |
|---|---|---|---|
| OWE | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement | FDA class 3 | Unknown |