Definition: A Next Generation Sequencing (NGS) Oncology Panel Is A Device Used For The Qualitative Detection Of Germline Or Somatic Variants In One Or More Cancer-related Genes. The Device Is Intended To Be Used On DNA Or RNA Isolated From Human Clinical Specime
| Device Type ID | 5051 |
| Device Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Physical State | Multiplex, High-throughput Next Generation Sequencing-based Test System. The Device May Include Hybridization- Or Amplification-based Capture Methods For Library Construction. Test Consists Of Reagents, Instrumentation, Software, And Instructions Nee |
| Technical Method | The Assay Uses Next Generation Sequencing Technology To Sequence And Identify Nucleic Acid Variants Located In Specified Genes Associated With Clinical Cancer Specimens. Variants Are Identified By Comparison To A Specified Reference Sequence. |
| Target Area | Human Clinical Specimens |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PQP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5051 |
| Device | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Product Code | PQP |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
False Negative Result | 1 |
Off-Label Use | 1 |
Incorrect Or Inadequate Test Results | 1 |
Unexpected Therapeutic Results | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Foundation Medicine, Inc. | II | Dec-20-2018 |
| 2 | Life Technologies Corporation | II | Apr-20-2018 |
| 3 | Life Technologies Corporation | II | Mar-30-2018 |