510(k) · Cleared
ClearedCellDx-Tissue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datar Cancer Genetics Private Limited · PZM Next Generation Sequencing Based Tumor Profiling Test
Cleared on May 12, 2026 as substantially equivalent to DEN170058 (Memorial Sloan-Kettering Cancer Center, 2017) after a 106-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- May 12, 2026
- Review
- 106 days
- Class
- Class II
- Product code
- PZM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170058 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170058 MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer…Memorial Sloan-Kettering Cancer Center · 2017
- This deviceK260235 CellDx-TissueDatar Cancer Genetics Private Limited · 2026
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) | K260235 | CellDx-Tissue | Datar Cancer Genetics Private Limited | 2026 | — |
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 K250003 GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)…score 10.2 · 2 generations · 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…Generation Sequencing Based Tumor Profiling Test 1.5.4 Legally Marketed Primary Predicate Device The legally marketed primary predicate device is MSK-IMPACT (DEN170058). Page 1 of 73 1.5.5 Reg… | 2017 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate DEN170058.
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. 2026, 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 CellDx-Tissue is a qualitative in vitro diagnostic (IVD) test that uses next-generation sequencing of DNA and RNA isolated from formalin-fixed paraffine-embedded (FFPE) tumor tissue from patients previously diagnosed with solid malignant neoplasm to detect tumor gene alterations in a broad multi-gene panel. The test is intended to provide tumor mutation profiling information on somatic mutations, including single nucleotide variants (SNVs)…
Read the full statement (123 words)
The CellDx-Tissue is a qualitative in vitro diagnostic (IVD) test that uses next-generation sequencing of DNA and RNA isolated from formalin-fixed paraffine-embedded (FFPE) tumor tissue from patients previously diagnosed with solid malignant neoplasm to detect tumor gene alterations in a broad multi-gene panel. The test is intended to provide tumor mutation profiling information on somatic mutations, including single nucleotide variants (SNVs), insertions and deletions (indels), one gene amplification, and three fusions.
Information provided by the CellDx-Tissue test is intended for use by qualified healthcare professionals in accordance with professional guidelines in oncology. Results from CellDx-Tissue are not intended to be conclusive or prescriptive for the labeled use of any specific therapeutic product. CellDx-Tissue is a single-site assay performed at Datar Cancer Genetics (DCG).
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/K260235 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260235: CellDx-Tissue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260235
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026