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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceAbbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime
Generic NameSomatic gene mutation detection system
ApplicantAbbott 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 Molecular Genetics
Clinical TrialsNCT02719574
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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).
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