| 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. |
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| Device | Abbott RealTime IDH1 |
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| Generic Name | Somatic gene mutation detection system |
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| Applicant | Abbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018 |
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| PMA Number | P170041 |
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| Date Received | 12/05/2017 |
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| Decision Date | 07/20/2018 |
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| Product Code |
OWD |
| Docket Number | 18M-2885 |
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| Notice Date | 07/26/2018 |
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| Advisory Committee |
Molecular Genetics |
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| Clinical Trials | NCT02074839
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 |
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