xT CDx
FDA premarket approval P210011 · decided 2023-04-28
Approval details
- PMA number
- P210011
- Trade name
- xT CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Tempus AI, Inc.
- Date received
- 2021-03-23
- Decision date
- 2023-04-28
- Days to decision
- 766 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Chicago, IL
- Statement
- Approval for the xT CDx. The device is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva sp
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| xR IVD (K241868) | Tempus AI, Inc. | 2025-09-19 |
| Tempus ECG-Low EF (K250119) | Tempus AI, Inc. | 2025-07-15 |
| Tempus ECG-AF (K233549) | Tempus AI, Inc. | 2024-06-21 |