Idylla MSI Test
Biocartis NV
BIOCARTIS NV
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009972873 | 3009972873 | BIOCARTIS NV | 1 | N | 2026-01-01 | Generaal De Wittelaan 11B Mechelen Antwerpen BE 2800 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 208844 | 1773337155 | P250005 | Idylla CDx MSI Test | SFL | 2025-08-15 |
| 208844 | 1803379048 | K211181 | Idylla MSI Test | PZJ | 2023-02-27 |
| 208844 | 1485146087 | K163628 | Idylla Respiratory (IFV-RSV) Panel | OCC | 2017-08-30 |
| 208844 | 1741950295 | ||||
| 208844 | 1929974056 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Idylla CDx MSI Test - For in vitro diagnostic use. For Prescription Use Only.For use on the Biocartis Idylla System only.The Idylla CDx MSI Test is an in vitro diagnostic test intended for the qualitative detection of a panel of sevenmonomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) for identification ofmicrosatellite instability (MSI) in colorectal cancer (CRC) tissue. The Idylla CDx MSI Test uses formalin-fixed,paraffin embedded (FFPE) tissue sections from patients with CRC, from which nucleic acids are extracted, thenanalyzed using PCR amplification and subsequent melt-curve analysis. The Idylla CDx MSI Test reports MSIstatus as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H) or invalid.The test is intended as a companion diagnostic to identify CRC patients with MSI-H status, who may benefitfrom treatment with OPDIVO (nivolumab) as a monotherapy and/or treatment with OPDIVO (nivolumab) incombination with YERVOY (ipilimumab).
2025-11-01
Idylla™ System - Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.
2017-08-21
Idylla™ System - The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch-screen that communicates with the Idylla™ Instruments. Idylla™ Console and up to eight Idylla™ Instruments constitute the Idylla™ System.
2017-08-21
Idylla™ MSI Test - 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.
2023-05-03
Idylla™ Respiratory (IFV-RSV) Panel - 1.0
2018-10-23