Approval for the abbott realtime idh2. The device is an in vitro polymerase chain reaction (pcr) assay for the qualitative detection of single nucleotide variants (snvs) coding nine idh2 mutations (r140q, r140l, r140g, r140w, r172k, r172m, r172g, r172s, and r172w) in dna extracted from blood (edta) or human bone marrow (edta). Abbott realtime idh2 is for use with the abbott m2000rt system. Abbott realtime idh2 is indicated as an aid in identifying acute myeloid leukemia (aml) patients with an isocitrate dehydrogenase-2 (idh2) mutation for treatment with idhifa® (enasidenib).
| Device | Abbott RealTime IDH2 |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Abbott Molecular Inc. |
| Date Received | 2017-02-02 |
| Decision Date | 2017-08-01 |
| Notice Date | 2017-08-28 |
| PMA | P170005 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 17M-4757 |
| Advisory Committee | Molecular Genetics |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Molecular Inc. 1300 E. 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 |
|---|
| P170005 | | Original Filing |
| S004 |
2022-03-10 |
Special (immediate Track) |
| S003 |
2021-02-05 |
30-day Notice |
| S002 |
2020-12-21 |
30-day Notice |
| S001 |
2019-08-29 |
30-day Notice |
NIH GUDID Devices