xR IVD
FDA 510(k) K241868 · Tempus AI, Inc.
510(k) numberK241868
Submission
- Device name
- xR IVD
- Applicant
- Tempus AI, Inc.
Chicago, IL, US - Received
- June 27, 2024
- Decision date
- September 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PZM – Next Generation Sequencing Based Tumor Profiling Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6080
- Specialty
- Pathology
A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.
Other 510(k)s with product code PZM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260235 | CellDx-TissuePZM · Traditional | Datar Cancer Genetics Private Limited | 05/12/2026SE |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)PZM · Traditional | Geneseeq Technology, Inc. | 08/29/2025SE |
| K210017 | ACTOnco, ACTOnco IVDPZM · Traditional | Act Genomics | 12/23/2022SE |
| K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)PZM · Traditional | Nyu Langone Medical Center | 07/14/2021SE |
| K192063 | PGDx elio tissue completePZM · Traditional | Personal Genome Diagnostics | 04/24/2020SE |
| K190661 | Omics CorePZM · Traditional | Nanthealth, Inc. | 11/09/2019SE |
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Questions and answers
When was xR IVD cleared by the FDA?
xR IVD (K241868) received a 510(k) decision of Substantially Equivalent on September 19, 2025, 449 days after the submission was received.
What is the product code of K241868?
The FDA product code is PZM – Next Generation Sequencing Based Tumor Profiling Test, a Class II (moderate risk) device regulated under 21 CFR 866.6080.