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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 avenue des plaines, IL 60018 |
PMA Number | P170041 |
Supplement Number | S006 |
Date Received | 12/17/2021 |
Decision Date | 12/01/2022 |
Product Code |
OWD |
Advisory Committee |
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Clinical Trials | NCT02719574
|
Supplement Type | normal 180 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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). |