K213348 is an FDA 510(k) clearance for the BOND MMR Antibody Panel. This device is classified as a Lynch Syndrome Test System (Class II - Special Controls, product code PZJ).
Submitted by Leica Biosystems Newcastle, Ltd. (Newcastle Upon Tyne, GB). The FDA issued a Cleared decision on February 21, 2023, 501 days after receiving the submission on October 8, 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 | K213348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2021 |
| Decision Date | February 21, 2023 |
| Days to Decision | 501 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 |