LeukoStrat CDx FLT3 Mutation Assay

FDA Premarket Approval P160040 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

The device, as modified, will be marketed under the trade name leukostrat cdx flt3 mutation assay and is indicated for:the leukostrat cdx flt3 mutation assay is a pcr-based in vitro diagnostic test designed to detect internal tandem duplication (itd) and tyrosine kinase domain (tkd) mutations d835 and i836 in the flt3 gene in genomic dna extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (aml). The leukostrat cdx flt3 mutation assay is used as an aid in the assessment of patients with aml for whom rydapt® (midostaurin) treatment is being considered. The leukostrat cdx flt3 mutation assay is used as an aid in the assessment of patients with aml for whom xospata® (gilteritinib) treatment is being considered. The test is for use on the 3500xl dx genetic analyzer.

DeviceLeukoStrat CDx FLT3 Mutation Assay
Generic NameSomatic Gene Mutation Detection System
ApplicantINVIVOSCRIBE TECHNOLOGIES, INC
Date Received2019-10-17
Decision Date2020-05-14
PMAP160040
SupplementS006
Product CodeOWD 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address INVIVOSCRIBE TECHNOLOGIES, INC 6330 Nancy Ridge Drive suite 106 san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P160040Original Filing
S006 2019-10-17 Normal 180 Day Track
S005
S004 2018-11-06 Real-time Process
S003 2018-04-12 Normal 180 Day Track No User Fee
S002 2018-03-30 Normal 180 Day Track
S001 2017-12-22 30-day Notice

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