Idylla™ MSI Test

GUDID 15415219000758

The Idylla MSI Test, for use on the Idylla System, uses formalin-fixed, paraffin embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis. The Idylla MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid.

Biocartis NV

Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT) Microsatellite instability IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15415219000758
• NIH Device Record Key: 63928393-c368-4a96-a344-1dfedde40b5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idylla™ MSI Test
• Version Model Number: 2
• Company DUNS: 400686169
• Company Name: Biocartis NV
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415219000751 [Unit of Use]
GS1	15415219000758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211181

FDA Product Code

• PZJ: Lynch Syndrome Test System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-11
• Device Publish Date: 2023-05-03

Devices Manufactured by Biocartis NV

• 15415219000758 - Idylla™ MSI Test: 2023-05-11The Idylla MSI Test, for use on the Idylla System, uses formalin-fixed, paraffin embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis. The Idylla MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid.
• 15415219000758 - Idylla™ MSI Test: 2023-05-11 The Idylla MSI Test, for use on the Idylla System, uses formalin-fixed, paraffin embedded (FFPE) tissue sections of human CRC tu
• 15415219000635 - Idylla™ Respiratory (IFV-RSV) Panel: 2018-11-23
• 05415219000119 - Idylla™ System: 2018-03-29 Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.
• 05415219000126 - Idylla™ System: 2018-03-29 The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch