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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceAbbott RealTime IDH1
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
Abbott Molecular, Inc.
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP170041
Date Received12/05/2017
Decision Date07/20/2018
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 18M-2885
Notice Date 07/26/2018
Advisory Committee Molecular Genetics
Clinical Trials NCT02074839
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Abbott RealTime IDH1. Abbott RealTime IDH1 is an in vitro polymerase chain reaction (PCR) assay for the qualitative detection of single nucleotide variants (SNVs) coding five IDH1 R132 mutations (R132C, R132H, R132G, R132S, and R132L) in DNA extracted from human blood (EDTA) or bone marrow (EDTA). Abbott RealTime IDH1 is for use with the Abbott m2000rt System.Abbott RealTime IDH1 is indicated as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-1 (IDH1) mutation for treatment with TIBSOVO® (ivosidenib). This test is for prescription use only.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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