AI Device Tracker / Clinical Chemistry
FDA-authorised AI devices in clinical chemistry
9 AI-enabled devices with clinical chemistry as the lead FDA review panel, newest first. First in this list: 2015; most recent: 2023-09-08.
| Decision date | Device | Company | FDA record |
|---|---|---|---|
| 2023-09-08 | Minuteful-kidney test | Healthy.io Ltd. | K222921 · 510(k) |
| 2023-06-29 | KidneyIntelX.dkd | Renalytix AI, Inc. | DEN200052 · De Novo |
| 2022-07-06 | Minuteful - kidney test | Healthy.io Ltd. | K210069 · 510(k) |
| 2019-07-26 | ACR LAB Urine Analysis Test System | Healthy.io Ltd | K182384 · 510(k) |
| 2019-07-18 | DreaMed Advisor Pro | DreaMed Diabetes Ltd | K191370 · 510(k) |
| 2018-07-18 | DIP/U.S. Urine Analysis Test System | Healthy.io Ltd | K173327 · 510(k) |
| 2018-06-12 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | DEN170043 · De Novo |
| 2016-11-30 | One Drop Blood Glucose Monitoring System | AgaMatrix, Inc. | K161834 · 510(k) |
| 2015-12-21 | Dario Blood Glucose Monitoring System | LabStyle Innovations Ltd. | K150817 · 510(k) |
How to read this list
- 510(k) clearance means the FDA found the device substantially equivalent to one already on the market. Most AI devices reach the market this way.
- De Novo is used for new, low-to-moderate risk device types with no existing equivalent; it creates a new device category.
- PMA approval is the strictest route, for higher-risk devices.
- Authorisation means the device may be sold in the US for its stated use. It does not prove that the device improves patient outcomes, and it does not mean your hospital uses it.
- This list covers US FDA decisions only. Approval in the EU (CE marking) or the UK (UKCA) is a separate process.
Source: FDA Artificial Intelligence-Enabled Medical Devices list, downloaded 2026-11-05. Information only, not a recommendation of any device.