PGDx elio plasma focus Dx

DEN230046 is the FDA 510(k) clearance record for PGDx elio plasma focus Dx, a class II device, cleared for Personal Genome Diagnostics, Inc. on 2024-08-01 under FDA product code SBY (High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids). FDA's definition for product code SBY reads: "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...". FDA records list 2 510(k) clearances for Personal Genome Diagnostics, Inc., from 2020-04-24 to 2024-08-01. As of 2026-09-10, FDA records show no recalls naming DEN230046.