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 Inherit
| Device Type ID | 4926 |
| Device Name | Lynch Syndrome Test System |
| Physical State | The Test May Include Detection Reagents, Instrument Systems And Software. May Also Include Specimen Handling And Processing Methods |
| Technical Method | The Test Uses Immunohistochemistry, DNA Amplification, Or DNA Sequencing Based Methods To Identify Defects In DNA Mismatch Repair Proteins And/or Microsatellite Instability In Tumor Tissue. Deficiencies Or Defects In DNA Mismatch Repair Proteins And/ |
| Target Area | Human Tissue Or Peripheral Blood For Normal Comparision |
| Regulation Description | Lynch Syndrome Test Systems. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 864.1866 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |