The vysis cll fish probe kit is a test to detect deletion of the lsi tp53 probe target via fluorescence in situ hybridization (fish) in peripheral blood specimens from patients with b-cell chronic lymphocytic leukemia (cll). The test is indicated for detecting deletion of the lsi tp53 probe target (17p-) as an aid in identifying those patients with cll for whom treatment with venclexta® (venetoclax) is indicated. Vysis cll fish probe kit is not intended for monitoring of residual disease.
| Device | VYSIS CLL FISH PROBE KIT |
| Classification Name | Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53) |
| Generic Name | Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53) |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2015-10-30 |
| Decision Date | 2016-04-11 |
| Notice Date | 2016-05-11 |
| PMA | P150041 |
| Supplement | S |
| Product Code | PNK |
| Docket Number | 16M-1167 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| 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 |
|---|
| P150041 | | Original Filing |
| S006 |
2020-11-16 |
30-day Notice |
| S005 |
2019-04-10 |
30-day Notice |
| S004 |
2018-08-10 |
30-day Notice |
| S003 |
2018-06-15 |
30-day Notice |
| S002 |
2018-02-16 |
30-day Notice |
| S001 |
2017-11-08 |
30-day Notice |
NIH GUDID Devices