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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceAbbott RealTime IDH2
Generic NameSomatic gene mutation detection system
ApplicantAbbott Molecular Inc.
1300 E. Touhy Avenue
Des Plaines, IL 60018
PMA NumberP170005
Date Received02/02/2017
Decision Date08/01/2017
Product Code OWD 
Docket Number 17M-4757
Notice Date 08/28/2017
Advisory Committee
Clinical TrialsNCT01915498
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S004 S001 S002 S003