510(k) DEN230046
DEN230046 is an FDA 510(k) premarket notification submitted by Personal Genome Diagnostics, Inc. for the device "PGDx elio plasma focus Dx". The FDA issued a decision of De Novo Granted on August 1, 2024. The device falls under product code SBY (High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids), a Class II device regulated under 21 CFR 866.6085. Personal Genome Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 1, 2024
- Date Received
- June 30, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
- Device Class
- Class II
- Regulation Number
- 866.6085
- Review Panel
- PA
- Submission Type
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.