PMA P170041S006

Device: Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime
Applicant: Abbott Molecular, Inc.
PMA number: P170041
Supplement: S006
Product code: OWD
Decision date: 2022-12-01
Generic name: Somatic gene mutation detection system
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).

Current openFDA PMA Record#

Device: Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime
Applicant: Abbott Molecular, Inc.
PMA number: P170041
Supplement: S006
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2022-12-01
Decision code: APPR
Date received: 2021-12-17
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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).