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U.S. Department of Health and Human Services

Product Classification

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Device somatic gene mutation detection system
Definition The flt3 mutation assay is a pcr-based, in vitro diagnostic test designed to detect internal tandem duplication (itd) mutations and the tyrosine kinase domain (tkd) mutations d835 and i836 in genomic dna extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia.The flt3 mutation assay is used as an aid in the assessment of acute myeloid leukemia patients for whom midostaurin treatment is being considered.The flt3 mutation assay is to be performed only at a preapproved laboratory site.
Physical State Test consists of reagents, instrumentation, software and instructions needed to perform the test method.
Technical Method In vitro amplification and detection of genomic DNA representing a somatic gene mutation from a cancerous specimen of interest.
Target Area Human clinical specimens of peripheral blood or bone marrow.
Review Panel Molecular Genetics
Product CodeOWD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible