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LeukoStrat CDx FLT3 Mutation Assay

by Invivoscribe Technologies, Inc.

PMA P160040

Active European Union and United States

CE IVDR PMA

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P160040↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP160040 Date28 Apr 2017ApprovedStatusActive
European UnionCE/IVDR Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA PMA Active

Specification

PMA

Generic Name
Somatic gene mutation detection system
PMA Number
FDA Product Code
OWD
Device Class
Class III
Advisory Committee
Pathology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test classified as a Somatic Gene Mutation Detection System. It is designed to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain mutations (D835 and I836) in the FLT3 gene within genomic DNA extracted from mononuclear cells sourced from peripheral blood or bone marrow aspirates of patients with acute myelogenous leukemia (AML).

This assay is intended for use solely at Laboratory for Personalized Molecular Medicine (LabPMM) LLC, located in San Diego, California. It is supplied as a single-use diagnostic tool and is authorized under FDA_PMA and IVDR regulations. The device requires specific laboratory conditions for performance and is not intended for general clinical use outside the designated facility.