K200129 is an FDA 510(k) clearance for the OncoMate MSI Dx Analysis System. This device is classified as a Lynch Syndrome Test System (Class II - Special Controls, product code PZJ).
Submitted by Promega Corporation (Madison, US). The FDA issued a Cleared decision on July 26, 2021, 552 days after receiving the submission on January 21, 2020.
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 | K200129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2020 |
| Decision Date | July 26, 2021 |
| Days to Decision | 552 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 |