Definition: A Gene Expression Test For Detection Of Cancer Metastasisis An In Vitro Diagnostic Test Performed On Tissue Of Interest From Patients Previously Diagnosed With Cancer. Results From The Test Can Be Used To Guide The Intra-operative Or Post-operative D
| Device Type ID | 3136 |
| Device Name | Rt-pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection |
| Physical State | Test Consists Of Reagents, Instrumentation, Software And Instructions Needed To Perform The Test Method. |
| Technical Method | In Vitro Replication, Amplification And Detection Of MRNA Representing The Product Of One Or Multiple Genes From A Cancerous Tissue Of Interest. |
| Target Area | Human Tissue From Known Cancer Patients, Removed During Biopsy Procedures For Detection Of Cancer Metastases. |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OCB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |