LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Premarket Approval P160040

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.

Pre-market Approval Supplement Details

Approval for the leukostrat® cdx flt3 mutation assay is a pcr-based, in vitro diagnostic test designed to detect internal tandem duplication (itd) mutations and the tyrosine kinase domain 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 selection of patients with aml for whom rydapt (midostaurin) treatment is being considered. The leukostrat® cdx flt3 mutation assay is to be performed only at laboratory for personalized molecular medicine (labpmm) llc, a single site laboratory located at 6330 nancy ridge dr. , san diego, ca 92121.

DeviceLeukoStrat CDx FLT3 Mutation Assay
Classification NameSomatic Gene Mutation Detection System
Generic NameSomatic Gene Mutation Detection System
ApplicantINVIVOSCRIBE TECHNOLOGIES, INC
Date Received2016-09-02
Decision Date2017-04-28
Notice Date2017-05-18
PMAP160040
SupplementS
Product CodeOWD
Docket Number17M-2766
Advisory CommitteePathology
Expedited ReviewYes
Combination Product No
Applicant Address INVIVOSCRIBE TECHNOLOGIES, INC 6330 Nancy Ridge Drive suite 106 san Diego, CA 92121
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P160040Original Filing
S009 2021-07-12 30-day Notice
S008 2021-07-09 Special (immediate Track)
S007
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

NIH GUDID Devices

Device IDPMASupp
00850052003685 P160040 004
00850052003739 P160040 006

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