LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Premarket Approval P160040 S001

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

Validation of the abi instruments and minor corrections to the instructions for use.

DeviceLeukoStrat CDx FLT3 Mutation Assay
Classification NameSomatic Gene Mutation Detection System
Generic NameSomatic Gene Mutation Detection System
ApplicantINVIVOSCRIBE TECHNOLOGIES, INC
Date Received2017-12-22
Decision Date2018-01-19
PMAP160040
SupplementS001
Product CodeOWD
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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

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