# K260235: CellDx-Tissue

- Pathway: 510(k) (Traditional)
- Applicant: Datar Cancer Genetics Private Limited
- Decided: May 12, 2026 after 106 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
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).

Source page: https://510kreport.com/device/K260235
Methodology: https://510kreport.com/methodology