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 Tumor Specimens Obtained From P
| Device Type ID | 5030 |
| Device Name | Next Generation Sequencing Based Tumor Profiling Test |
| Physical State | The Test May Also Include Specimen Handling, Nucleic Acid Purification Methods, Target Enrichment, Library Preparation And Sequencing Reagents, Instrument Systems And Software. |
| Technical Method | High Throughput, Massive Parallel Targeted Sequencing Including Molecular Reagents For Target Enrichment, Library Preparation And Sequencing Using Multiplexed Polymerase Chain Reactions , Sequencing Instrumentation And Bioinformatics Software. May Al |
| Target Area | Human Tumor Tissue Specimens And Matched Normal Tissue Or Matched Peripheral Whole Blood. |
| Regulation Description | Next Generation Sequencing Based Tumor Profiling Test. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6080 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5030 |
| Device | Next Generation Sequencing Based Tumor Profiling Test |
| Product Code | PZM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Next Generation Sequencing Based Tumor Profiling Test. |
| CFR Regulation Number | 866.6080 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEMORIAL SLOAN-KETTERING CANCER CENTER | ||
GRANTED | 1 | |