FDA-cleared AI clinical chemistry devices
The FDA's AI-enabled device list has 9 devices whose lead review panel is Clinical Chemistry, 0.6% of all 1,614 listed devices. They come from 7 companies. The first decision was on December 21, 2015 and the most recent on September 8, 2023.
9AI devices
5Companies
2015First decision
2023-09-08Latest decision
Trend: devices per year
201520162018201920222023
Top companies
Most common product codes
All 9 devices, newest first
- Minuteful-kidney testHealthy.io Ltd. · Clinical Chemistry
- KidneyIntelX.dkdRenalytix AI, Inc. · Clinical Chemistry
- Minuteful - kidney testHealthy.io Ltd. · Clinical Chemistry
- ACR LAB Urine Analysis Test SystemHealthy.io Ltd · Clinical Chemistry
- DreaMed Advisor ProDreaMed Diabetes Ltd · Clinical Chemistry
- DIP/U.S. Urine Analysis Test SystemHealthy.io Ltd · Clinical Chemistry
- DreaMed Advisor ProDreaMed Diabetes, Ltd. · Clinical Chemistry
- One Drop Blood Glucose Monitoring SystemAgaMatrix, Inc. · Clinical Chemistry
- Dario Blood Glucose Monitoring SystemLabStyle Innovations Ltd. · Clinical Chemistry
Frequently asked questions
How many FDA-cleared AI clinical chemistry devices are there?
As of the FDA list updated through June 29, 2026, 9 AI-enabled devices have Clinical Chemistry as their lead review panel (0.6% of the list).
Which companies have the most AI clinical chemistry devices?
Healthy.io Ltd. (2), Healthy.io Ltd (2), Renalytix AI, Inc. (1) have the most AI-enabled clinical chemistry devices on the FDA list.
Which year had the most AI clinical chemistry authorizations?
2018 had the most, with 2 devices.
Which FDA pathways are used for AI clinical chemistry devices?
510(k): 7; De Novo: 2.
What was the most recent AI clinical chemistry device on the list?
Minuteful-kidney test from Healthy.io Ltd. (K222921), with a decision dated September 8, 2023.