FDA.reportPublic FDA data

LeukoStrat

Primary DI
00850052003685
Brand
LeukoStrat
Company
INVIVOSCRIBE, INC.
Model
850052003685
Catalog number
K4120221
Device description
The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations, such as the D835 and I836 mutations. The LeukoStrat CDx FLT3 Mutation Assay includes reagents, equipment, software and procedures for isolating mononuclear cells and extracting DNA from patient specimens to determine if FLT3 mutations are present. DNA is amplified via PCR, TKD amplicon is enzymatically digested, and the amplicons are detected via capillary electrophoresis.
Published
2020-05-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OWDSomatic Gene Mutation Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWDSomatic Gene Mutation Detection SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160040004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160040004LeukoStrat CDx FLT3 Mutation AssayInvivoscribe Technologies, Inc.2017-04-28OWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850052003685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850052003685008500520036858500520036850850052003685

GMDN Terms#

Term, Definition table
TermDefinition
Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict acute myeloid leukaemia (AML) based on changes at the gene or chromosomal level which may include FLT3 gene mutations, NPM1 gene mutations, t(8;21), inv(16) and/or t(15;17), using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
836976779
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810022732571LeukoStrat00810022732571K41203612023-05-30
00850052003739LeukoStrat850052003739K41203612020-06-08
00810022730638Invivoscribe810022730638A31000302021-02-02
00810022730676Invivoscribe810022730676A31000812021-02-02
00810022730744Invivoscribe810022730744A41200092022-01-18
00810022730768Invivoscribe810022730768A41200192022-01-18
00810022730775Invivoscribe810022730775A41200292022-01-18
00810022730805Invivoscribe810022730805A41200392022-01-18
00810022730812Invivoscribe810022730812A41200492022-01-18
00810022730829Invivoscribe810022730829A41200592022-01-18
00810022730843Invivoscribe810022730843A41200692022-01-18
00810022730867Invivoscribe810022730867A41200792022-01-18
00810022730881Invivoscribe810022730881A41200892022-01-18
00810022730898Invivoscribe810022730898A41200992022-01-18
00810022730911Invivoscribe810022730911A41201192022-01-18
00810022730928Invivoscribe810022730928A41201292022-01-18
00810022730935Invivoscribe810022730935A41201392022-01-18
00810022730942Invivoscribe810022730942A41201492022-01-18
00810022730959Invivoscribe810022730959A41201592022-01-18
00810022730973Invivoscribe810022730973A41201792022-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053228034834therascreen® PDGFRA RGQ PCR KitQIAGEN GmbHOWD2024-12-10
00810022732571LeukoStratINVIVOSCRIBE, INC.OWD2023-05-30
04053228043560therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2022-05-23
00054749005505i-STATABBOTT POINT OF CARE INC.OWD2020-10-05
00875197005592cobas&#x00AE EZH2 Mutation TestRoche Molecular Systems, Inc.OWD2020-08-01
00054749005123i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005147i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005154i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005161i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005178i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005185i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005192i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005208i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005215i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005222i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005529i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
04053228035725therascreen® BRAF RGQ PCR KitQIAGEN GmbHOWD2020-06-11
00850052003739LeukoStratINVIVOSCRIBE, INC.OWD2020-06-08
00054749005512i-STATABBOTT POINT OF CARE INC.OWD2020-05-01
00054749005093i-STATABBOTT POINT OF CARE INC.OWD2019-12-20
04053228034223therascreen® PIK3CA RGQ PCR KitQIAGEN GmbHOWD2019-06-05
04053228034094therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2019-04-29
00884999047792RealTimeABBOTT MOLECULAR INC.OWD2018-08-06
00884999047341RealTimeABBOTT MOLECULAR INC.OWD2018-07-30
00884999047358RealTimeABBOTT MOLECULAR INC.OWD2018-07-30
00884999047037RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
00884999047044RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
00884999047051RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
03573026559823THxID™ BRAFBIOMERIEUX SAOWD2017-05-12
04053228002048therascreen® KRAS RGQ PCR KitQIAGEN GmbHOWD2017-01-04