Definition: A Next-generation Sequencing Based Tumor Profiling Test Is A Qualitative In Vitro Diagnostic Test Intended To Detect Mutations In A Broad Panel Of Targeted Genes That Are Somatically Altered In Malignant Neoplasms From Nucleic Acids Isolated From Hum
| Device Type ID | 5053 |
| Device Name | Tumor Gene Profiling Test |
| Physical State | The Device May Include Specimen Handling, Nucleic Acid Purification Methods, Specialized Molecular Reagents For Target Enrichment, Library Preparation And Sequencing Reagents, Instrument Systems And Software. May Also Include Algorithms Based On Sequ |
| Technical Method | The Device Utilizes High Throughput, Massively Parallel Targeted Sequencing Including Molecular Reagents For Target Enrichment, Library Preparation, And Sequencing Using Multiplexed Polymerase Chain Reactions, Sequencing Instrumentation, And Bioinfor |
| Target Area | Nucleic Acids Isolated From Human Clinical Specimens [e.g., Cell Free, Circulating Tumor DNA (ctDNA) From Human Plasma, DNA Isolated From Formalin-fixed, Paraffin-embedded Tumor Tissue, Etc.] And Matched Normal Tissue Or Peripheral Whole Blood. |
| Review Panel | Pathology |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | QFK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |