Abbott RealTime IDH1
FDA premarket approval P170041 · decided 2018-07-20
Approval details
- PMA number
- P170041
- Trade name
- Abbott RealTime IDH1
- Generic name
- Somatic gene mutation detection system
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2017-12-05
- Decision date
- 2018-07-20
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Des Plaines, IL
- 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 dehyd
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