LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Premarket Approval P160040 S004

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

Approval for the leukostrat cdx flt3 mutation assay. The device is a pcr-based in vitro diagnostic test designed to detect internal tandem duplications (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 selection 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 selection of patients with aml for whom xospata® (gilteritinib) 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 laboratory site, located at 10222 barnes canyon rd. , bldg. 1, 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 Received2018-11-06
Decision Date2018-12-21
PMAP160040
SupplementS004
Product CodeOWD
Advisory CommitteePathology
Supplement TypeReal-time Process
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
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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.