LeukoStrat CDx FLT3 Mutation Assay

FDA Premarket Approval P160040 S009

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

Qualification of an automated process for fill, finish, and label the kit components

• Device: LeukoStrat CDx FLT3 Mutation Assay
• Generic Name: Somatic Gene Mutation Detection System
• Applicant: INVIVOSCRIBE TECHNOLOGIES, INC
• Date Received: 2021-07-12
• Decision Date: 2021-08-11
• PMA: P160040
• Supplement: S009
• Product Code: OWD
• Advisory Committee: Pathology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: INVIVOSCRIBE TECHNOLOGIES, INC 10222 Barnes Canyon Road, Building 1 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