Idylla CDx MSI Test
Basic Information
- Brand Name
- Idylla CDx MSI Test
- Primary DI
- 15415219001328
- Version / Model
- v3
- Company Name
- Biocartis NV
- Labeler DUNS
- 400686169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-01
- Public Version
- 1
- Public Version Date
- 2025-11-10
- Public Version Status
- New
- Public Device Record Key
- 397729ff-744f-409a-950a-9a80b26c948d
Device Description
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 seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) for identification of microsatellite 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, then analyzed using PCR amplification and subsequent melt-curve analysis. The Idylla CDx MSI Test reports MSI status 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 benefit from treatment with OPDIVO (nivolumab) as a monotherapy and/or treatment with OPDIVO (nivolumab) in combination with YERVOY (ipilimumab).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SFL | Idylla Cdx Msi Test | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60202 | 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15415219001328 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P250005 | 000 |