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510(k) Data Aggregation
K Number
K200129Device Name
OncoMate MSI Dx Analysis System
Manufacturer
Date Cleared
2021-07-26
(552 days)
Product Code
Regulation Number
864.1866Why did this record match?
Applicant Name (Manufacturer) :
Promega Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OncoMate™ MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed, paraffin-embedded (FFPE) colorectal tissue sections. The OncoMate™ MSI Dx Analysis System is for use with the Applied Biosystems® 3500Dx Genetic Analyzer and OncoMate™ MSI Dx Interpretive Software.
The OncoMate™ MSI Dx Analysis System is indicated in patients diagnosed with colorectal cancer (CRC) to detect microsatellite instability (MSI) as an aid in the identification of probable Lynch syndrome to help identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome.
Results from the OncoMate™ MSI Dx Analysis System should be interpreted by healthcare professionals in conjunction with other clinical findings, family history, and other laboratory data.
The clinical performance of this device to guide treatment decision for MSI high patients has not been established.
Device Description
The OncoMate™ MSI Dx Analysis System assay encompasses a complete workflow for MSI determination, from DNA extraction to data analysis. DNA is extracted from FFPE colorectal tissue samples (normal and tumor from the same patient) using the Maxwell® CSC DNA FFPE Kit and Maxwell® CSC Instrument. Double-stranded DNA (dsDNA) is then quantified using a fluorescence-based dsDNA quantification system of the user's choice. Next, amplification products are generated through multiplex PCR amplification of DNA microsatellite markers using the OncoMate™M MSI Dx Analysis System amplification kit. The PCR products are then mixed with Hi-Di™ Formamide and Size Standard 500 and heat-denatured. The resulting single-stranded DNA fragments are separated by size and detected via fluorescence using an Applied Biosystems® 3500Dx Genetic Analyzer. Following capillary electrophoresis, allele sizes from the CRC tumor DNA and the normal DNA are calculated and compared for each of the microsatellite markers using OncoMate™ MSI Dx Interpretive Software. If the length of two or more of the five mononucleotide-repeat marker alleles is changed by ≥2.75 base pairs (bp), the tumor is classified as MSI-H; if the allele length is changed for only one marker, or if the difference in allele lengths at the five markers is <2.75bp, the tumor is classified as Microsatellite Stable (MSS). The sizes of the Penta C and Penta D pentanucleotide-repeat marker alleles are compared as an identity check between the normal and tumor DNA samples.
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