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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceAbbott RealTime IDH2
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
Abbott Molecular Inc.
1300 e. touhy avenue
des plaines, IL 60018
PMA NumberP170005
Date Received02/02/2017
Decision Date08/01/2017
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 17M-4757
Notice Date 08/28/2017
Advisory Committee Molecular Genetics
Clinical Trials NCT01915498
NCT02577406
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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