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.
| Device | Vysis ALK Break Apart Fish Probe Kit |
| Generic Name | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2019-12-23 |
| Decision Date | 2020-05-22 |
| PMA | P110012 |
| Supplement | S020 |
| Product Code | OWE |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P110012 | | Original Filing |
| S021 |
2020-11-16 |
30-day Notice |
| S020 |
2019-12-23 |
Normal 180 Day Track |
| S019 |
2019-07-31 |
30-day Notice |
| S018 |
2019-04-10 |
30-day Notice |
| S017 |
2018-08-10 |
30-day Notice |
| S016 |
2018-06-15 |
30-day Notice |
| S015 |
2018-02-16 |
30-day Notice |
| S014 |
2017-11-08 |
30-day Notice |
| S013 |
2016-11-22 |
Real-time Process |
| S012 |
2016-09-12 |
30-day Notice |
| S011 |
2016-09-02 |
30-day Notice |
| S010 |
2016-06-01 |
30-day Notice |
| S009 |
2014-10-01 |
Normal 180 Day Track |
| S008 |
2014-07-24 |
30-day Notice |
| S007 |
2014-08-14 |
Real-time Process |
| S006 |
2014-06-16 |
30-day Notice |
| S005 |
2013-11-05 |
30-day Notice |
| S004 |
2013-08-29 |
Normal 180 Day Track No User Fee |
| S003 |
2013-03-20 |
30-day Notice |
| S002 |
2012-11-15 |
30-day Notice |
| S001 |
2011-12-19 |
135 Review Track For 30-day Notice |
NIH GUDID Devices