# K192063: PGDx elio tissue complete

- Pathway: 510(k) (Traditional)
- Applicant: Personal Genome Diagnostics
- Decided: Apr 24, 2020 after 267 days
- Product code: PZM (Next Generation Sequencing Based Tumor Profiling Test)
- Device class: 2
- Regulation: 21 CFR 866.6080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170058 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170058: MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay, Memorial Sloan-Kettering Cancer Center (2017) Summary page 5.

## Most influential descendants
- K250003: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) (2025), 0 descendants of its own

## Indications for use
The PGDx elio™ tissue complete assay is a qualitative in vitro diagnostic device that uses targeted next generation sequencing of DNA isolated from formalin-fixed, paraffin-embedded tumor tissue from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi-gene panel. PGDx elio tissue complete is intended to provide tumor mutation profiling information on somatic alterations (SNVs, small insertions and deletions, one amplification and four translocations), microsatellite instability (MSI) and tumor mutation burden (TMB) for use by qualified healthcare professionals in accordance with professional guidelines in oncology for previously diagnosed cancer patients, and is not conclusive or prescriptive for labeled use of any specific therapeutic product.

Source page: https://510kreport.com/device/K192063
Methodology: https://510kreport.com/methodology