Definition: The Somatic Gene Mutation Detection System Is An In Vitro Diagnostic Nucleic Acid Amplification And Real-time Detection System For The Identification Of Genetic Mutations In DNA Extracted From Human Tumor Tissues.
| Device Type ID | 3138 |
| Device Name | Somatic Gene Mutation Detection System |
| Physical State | Test Consists Of Reagents, Instrumentation, Software And Instructions Needed To Perform The Test Method. |
| Technical Method | In Vitro Amplification And Detection Of Genomic DNA Representing A Somatic Gene Mutation From A Cancerous Specimen Of Interest. |
| Target Area | Human Clinical Specimens Of Peripheral Blood Or Bone Marrow. |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OWD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3138 |
| Device | Somatic Gene Mutation Detection System |
| Product Code | OWD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Roche Molecular Systems, Inc. | II | Jul-21-2016 |
| 2 | Roche Molecular Systems, Inc. | II | May-26-2016 |
| 3 | Roche Molecular Systems, Inc. | III | Jun-26-2015 |
| 4 | Roche Molecular Systems, Inc. | III | Mar-25-2015 |