510(k) · Cleared
ClearedPGDx elio tissue complete
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Personal Genome Diagnostics · PZM Next Generation Sequencing Based Tumor Profiling Test
Cleared on Apr 24, 2020 as substantially equivalent to DEN170058 (Memorial Sloan-Kettering Cancer Center, 2017) after a 267-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.
- Decided
- Apr 24, 2020
- Review
- 267 days
- Class
- Class II
- Product code
- PZM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170058 (2017). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN170058 MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer…Memorial Sloan-Kettering Cancer Center · 2017
- This deviceK192063 PGDx elio tissue completePersonal Genome Diagnostics · 2020
- Descendant · cites it directly · 0 of its ownK250003 GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a… | Memorial Sloan-Kettering Cancer Center | 2017 | — |
| 0 (this device) | K192063 | PGDx elio tissue complete | Personal Genome Diagnostics | 2020 | — |
| +1 | K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PZM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PZM device
- #1 K260235 CellDx-Tissuescore 11.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a…Summary page 5…ents NextSeq® 550Dx (qualified by PGDx) F. Substantial Equivalence Information: 1. Predicate device name(s) MSK-IMPACT 2. Predicate 510(k) Number DEN170058 3. Comparison with predicate MSK-IMPACT PGDx elio ti… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PZM devicesPZM Next Generation Sequencing Based Tumor Profiling Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PZM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZM
Too few PZM 510(k)s in any year since 2007 to give a median.
Recalls per year · PZM
No recall names PZM since 2007.
Adverse event reports per year · PZM
No MAUDE report names PZM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (108 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192063: PGDx elio tissue complete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192063
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026