510(k) · Cleared
ClearedGENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geneseeq Technology, Inc. · PZM Next Generation Sequencing Based Tumor Profiling Test
Cleared on Aug 29, 2025 as substantially equivalent to K192063 (Personal Genome Diagnostics, 2020) after a 239-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Aug 29, 2025
- Review
- 239 days
- Class
- Class II
- Product code
- PZM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170058 (2017). No later device cites it as a predicate yet.
- Root · 2 generations backDEN170058 MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer…Memorial Sloan-Kettering Cancer Center · 2017
- 1 generation backK192063 PGDx elio tissue completePersonal Genome Diagnostics · 2020
- This deviceK250003 GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a… | Memorial Sloan-Kettering Cancer Center | 2017 | — |
| −1 | K192063 | PGDx elio tissue complete | Personal Genome Diagnostics | 2020 | — |
| 0 (this device) | K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K192063 | PGDx elio tissue completeSummary page 19…ntial Equivalence Information 1. Predicate Device Name(s): PGDx elio Tissue Complete 2. Predicate Device 510(k) Number K192063 3. Comparison of technological characteristics with the predicate device… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
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. 2025, 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 GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) is a qualitative in vitro diagnostic test kit that uses next generation sequencing of DNA isolated from formalin-fixed paraffin-embedded tumor tissue from previously diagnosed patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. This test is intended to provide tumor mutation profiling information on somatic variants, including single nucleotide variants…
Read the full statement (131 words)
The GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) is a qualitative in vitro diagnostic test kit that uses next generation sequencing of DNA isolated from formalin-fixed paraffin-embedded tumor tissue from previously diagnosed patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. This test is intended to provide tumor mutation profiling information on somatic variants, including single nucleotide variants (SNVs), insertions and deletions (indels), one amplification, four translocations, microsatellite instability (MSI), and tumor mutation burden (TMB).
Information provided by GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology. Results from GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) are not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250003 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250003: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250003
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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