SBY · High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
Pathology · 21 CFR 866.6085 · Class 2
Overview
| Product Code | SBY |
|---|---|
| Device Name | High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids |
| Regulation | 21 CFR 866.6085 |
| Device Class | Class 2 |
| Review Panel | Pathology |
Identification
A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230046 | PGDx elio plasma focus Dx | Personal Genome Diagnostics, Inc. | Aug 1, 2024 | DENG |
Top Applicants
- Personal Genome Diagnostics, Inc. — 1 clearance
