| 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 IDH2 |
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| Generic Name | Somatic gene mutation detection system |
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| Applicant | Abbott Molecular Inc.
1300 E. Touhy Avenue
Des Plaines, IL 60018 |
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| PMA Number | P170005 |
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| Date Received | 02/02/2017 |
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| Decision Date | 08/01/2017 |
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| Product Code |
OWD |
| Docket Number | 17M-4757 |
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| Notice Date | 08/28/2017 |
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| Advisory Committee |
|
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| Clinical Trials | NCT01915498
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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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 |
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