LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Premarket Approval P160040 S002

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.

• Device: LeukoStrat CDx FLT3 Mutation Assay
• Classification Name: Somatic Gene Mutation Detection System
• Generic Name: Somatic Gene Mutation Detection System
• Applicant: INVIVOSCRIBE TECHNOLOGIES, INC
• Date Received: 2018-03-30
• Decision Date: 2018-11-28
• PMA: P160040
• Supplement: S002
• Product Code: OWD
• Advisory Committee: Pathology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: INVIVOSCRIBE TECHNOLOGIES, INC 6330 Nancy Ridge Drive suite 106 san Diego, CA 92121

Supplemental Filings

Supplement Number	Date	Supplement Type
P160040		Original Filing
S010	2022-03-15	30-day Notice
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 ID	PMA	Supp
00850052003685	P160040	004
00850052003739	P160040	006
00810022732571	P160040	006