Approval for the vysis alk break apart fish probe kit; vysis paraffin pretreatment iv & post hybridization wash buffer kit; probechek alk negative control slides; and probechek alk positive control slides. This device is indicated for: 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) non-small cell lung cancer (nsclc) tissue specimens to aid in identifying those patients eligible for treatment with xalkori crizotinib). The test is for prescription use only. The vysis paraffin pretreatment iv & post hybridization wash buffer kit is used to prepare paraffin-embedded lung cancer tissue sections fixed on positively charged slides for use in fluorescence in situ hybridization (fish) with vysis dna fish probes. The probechek alk negative control slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit (list no. 06n38-020). The probechek alk negative control slides should be assayed in conjunction with the user's specimen slides according the package insert for the vysis alk break apart fish probe kit (list no. 06n38-020). The probechek alk positive control slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit (list no. 06n38-020). The probechek alk positive control slides should be assayed in conjunction with the user's specimen slides according the package insert for the vysis alk break apart fish probe kit (list no. 06n38-020).
| Device | VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK |
| Classification Name | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Generic Name | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2011-04-01 |
| Decision Date | 2011-08-26 |
| Notice Date | 2011-09-06 |
| PMA | P110012 |
| Supplement | S |
| Product Code | OWE |
| Docket Number | 11M-0630 |
| Advisory Committee | Pathology |
| Expedited Review | Yes |
| Combination Product | Yes |
| Applicant Address | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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