This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Abbott Molecular, Inc.1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP170041 Supplement NumberS006 Date Received12/17/2021 Decision Date12/01/2022 Product Code OWD Advisory Committee Clinical TrialsNCT02719574 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-12-01 |
| PMA | P170041 |
| Supplement | S006 |
| Product Code | OWD |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Molecular, Inc. 1300 East Touhy Avenue des Plaines, IL 60018 PMA NumberP170041 Supplement NumberS006 Date Received12/17/2021 Decision Date12/01/2022 Product Code OWD Advisory Committee Clinical TrialsNCT02719574 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval To Expand The Indications For Use Of The Abbott RealTime IDH1 Assay To Include A Companion Diagnostic Indication For The Detection Of Isocitrate Dehydrogenase-1 (IDH1) Mutations In Patients With Acute Myeloid Leukemia (AML) Who May Benefit From Treatment With REZLIDHIA™ (olutasidenib). |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00884999047792 | P170041 | 000 |
| 00884999047358 | P170041 | 000 |
| 00884999047341 | P170041 | 000 |