- Device
- Vysis ALK Break Apart Fish Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S020
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2020-05-22
- Decision code
- APPR
- Date received
- 2019-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.