K211181 is an FDA 510(k) clearance for the Idylla MSI Test. This device is classified as a Lynch Syndrome Test System (Class II - Special Controls, product code PZJ).
Submitted by Biocartis NV (Mechelen, BE). The FDA issued a Cleared decision on February 27, 2023, 678 days after receiving the submission on April 20, 2021.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1866. The Lynch Syndrome Test System Is Used To Identify Loss Of Dna Mismatch Repair Proteins Or Microsatellite Instability In Tumor Tissue From Cancer Patients For The Purpose Of Identifying Patients Who May Benefit From Additional Testing For The Inherited Cancer Predisposition Lynch Syndrome.
| 510(k) Number | K211181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2021 |
| Decision Date | February 27, 2023 |
| Days to Decision | 678 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | PZJ - Lynch Syndrome Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1866 |
| Definition | The Lynch Syndrome Test System Is Used To Identify Loss Of Dna Mismatch Repair Proteins Or Microsatellite Instability In Tumor Tissue From Cancer Patients For The Purpose Of Identifying Patients Who May Benefit From Additional Testing For The Inherited Cancer Predisposition Lynch Syndrome |