FDA.reportPublic FDA data

OncoMate MSI Dx Analysis System

Primary DI
00849811031717
Brand
OncoMate MSI Dx Analysis System
Company
PROMEGA CORPORATION
Model
MD2140
Catalog number
MD2140
Device description
Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.
Published
2021-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PZJLynch Syndrome Test System
SFLNucleic Acid Based Assay, Microsatellite Instability

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZJLynch Syndrome Test SystemImmunology2
SFLNucleic Acid Based Assay, Microsatellite InstabilityUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200129000
P240026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200129000OncoMate MSI Dx Analysis SystemPromega Corporation2021-07-26PZJ
P240026000OncoMate® MSI Dx Analysis SystemPromega Corporation2025-11-05SFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849811031717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849811031717008498110317178498110317170849811031717

GMDN Terms#

Term, Definition table
TermDefinition
Microsatellite instability IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for determining microsatellite instability [abnormal repeated sequences of deoxyribonucleic acid (DNA)] within a tumour tissue specimen, using a nucleic acid technique (NAT). This phenomenon which is associated with defective DNA mismatch repair genes is a feature of certain cancer types including hereditary nonpolyposis colon cancer (HNPCC).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
089855696
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849811081835Maxwell® CSC Rapid ccfDNA KitAS1580AS15802026-02-16
00849811083457OncoMate® MSI Dx Analysis SoftwareMD4160MD41602026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitAS1560AS15602026-02-16
00849811089114OncoMate® MSI Dx Assay InstallerMD4130MD41302026-02-16
00849811050619OncoMate 5C Matrix StandardMD4850MD48502021-09-30
00849811066115Maxwell® CSC Genomic DNA KitAS1850AS18502023-06-12
00849811060960Maxwell® CSC Viral Total Nucleic Acid Purification Kit AS1780AS17802022-02-01
00849811064647Maxwell® CSC Whole Blood DNA KitAS1820AS18202022-02-01
00849811069062Maxwell® CSC Pathogen Total Nucleic Acid Kit AS1860AS18602023-06-12
00849811051340Maxwell® CSC InstrumentAS6000AS60002022-02-01
00849811060991Maxwell® CSC 48 InstrumentAS8000AS80002022-02-01
00849811075902QuantiFluor® Dx dsDNA SystemE5900E59002023-08-15
00849811051739Maxwell® CSC RNA Blood KitAS1410AS14102022-02-01
00849811051746Maxwell® CSC RNA FFPE KitAS1360AS13602022-02-01
00849811051753Maxwell® CSC DNA FFPE KitAS1350AS13502022-02-01
00849811051777Maxwell® CSC Blood DNA KitAS1321AS13212022-02-01
00849811056857OncoMate MSI Dx Interpretive SoftwareMD4140MD41402021-10-08
00849811056864OncoMate MSI Dx Assay InstallerMD4150MD41502021-10-08
00849811004445Abbott mSample Preparation System04J70-2404J70-242017-08-25
00849811004452Abbott mSample Preparation System DNA06K12-2406K12-242017-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849811083457OncoMate® MSI Dx Analysis SoftwarePROMEGA CORPORATIONSFL2026-02-16
00849811089114OncoMate® MSI Dx Assay InstallerPROMEGA CORPORATIONSFL2026-02-16
15415219001328Idylla CDx MSI TestBiocartis NVSFL2025-11-01
15415219000758Idylla™ MSI TestBiocartis NVPZJ2023-05-03
05055331335906BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331335920BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331336002BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331336019BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
00849811056857OncoMate MSI Dx Interpretive SoftwarePROMEGA CORPORATIONPZJ2021-10-08
00849811056864OncoMate MSI Dx Assay InstallerPROMEGA CORPORATIONPZJ2021-10-08
00849811050619OncoMate 5C Matrix StandardPROMEGA CORPORATIONSFL2021-09-30
00849811050619OncoMate 5C Matrix StandardPROMEGA CORPORATIONPZJ2021-09-30
07613336100561VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100578VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100585VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100592VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100608VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08