| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | Vysis ALK Break Apart FISH Probe Kit |
|---|
| Generic Name | Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement |
|---|
| Applicant | Abbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018 |
|---|
| PMA Number | P110012 |
|---|
| Supplement Number | S022 |
|---|
| Date Received | 02/05/2024 |
|---|
| Decision Date | 08/05/2025 |
|---|
| Product Code |
OWE |
| Advisory Committee |
Pathology |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
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 ENSACOVE® (ensartinib). 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 USE The Vysis ALK Break Apart FISH Probe Kit is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ALUNBRIG® (brigatinib), and ENSACOVE® (ensartinib) in accordance with the approved therapeutic product labeling. |
|
|
