xT CDx is an AI-enabled medical device from Tempus Labs, Inc. that the U.S. FDA approved through PMA P210011 on April 28, 2023. Its lead review panel is Pathology and its primary product code is PQP.
See also all FDA AI clearances in 2023.
Key facts
| Submission number | P210011 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | Tempus Labs, Inc. |
| Lead review panel | Pathology |
| Primary product code | PQP |
Source: FDA AI-Enabled Medical Devices list. No matching openFDA record was found for this submission yet.
What this means
Premarket Approval (PMA) is FDA's most stringent pathway, used for Class III devices. It requires valid scientific evidence of safety and effectiveness. xT CDx went through this pathway (P210011).
Product code PQP covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Tempus Labs, Inc. has 1 AI-enabled device on the list, and the Pathology panel accounts for 10 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.