Abbott RealTime IDH2
FDA premarket approval P170005 · decided 2017-08-01
Approval details
- PMA number
- P170005
- Trade name
- Abbott RealTime IDH2
- Generic name
- Somatic gene mutation detection system
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2017-02-02
- Decision date
- 2017-08-01
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Des Plaines, IL
- 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 iso
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