Approval for the abbott realtime idh1. Abbott realtime idh1 is an in vitro polymerase chain reaction (pcr) assay for the qualitative detection of single nucleotide variants (snvs) coding five idh1 r132 mutations (r132c, r132h, r132g, r132s, and r132l) in dna extracted from human blood (edta) or bone marrow (edta). Abbott realtime idh1 is for use with the abbott m2000rt system. Abbott realtime idh1 is indicated as an aid in identifying acute myeloid leukemia (aml) patients with an isocitrate dehydrogenase-1 (idh1) mutation for treatment with tibsovo® (ivosidenib). This test is for prescription use only.
| Device | Abbott RealTime IDH1 |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Abbott Molecular, Inc. |
| Date Received | 2017-12-05 |
| Decision Date | 2018-07-20 |
| Notice Date | 2018-07-26 |
| PMA | P170041 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 18M-2885 |
| Advisory Committee | Molecular Genetics |
| 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 |
|---|
| P170041 | | Original Filing |
| S006 |
2021-12-17 |
Normal 180 Day Track |
| S005 |
2021-02-05 |
30-day Notice |
| S004 | | |
| S003 |
2020-12-21 |
30-day Notice |
| S002 |
2019-10-16 |
30-day Notice |
| S001 |
2019-08-29 |
30-day Notice |
NIH GUDID Devices