# K241868: xR IVD

- Pathway: 510(k) (Traditional)
- Applicant: Tempus AI, Inc.
- Decided: Sep 19, 2025 after 449 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 Tempus xR IVD assay is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of rearrangements in two genes, using RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms. Information provided by xR IVD is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Results from xR IVD are not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product.

Source page: https://510kreport.com/device/K241868
Methodology: https://510kreport.com/methodology