FDA-cleared AI clinical toxcicology devices
The FDA's AI-enabled device list has 5 devices whose lead review panel is Clinical Toxcicology, 0.3% of all 1,614 listed devices. They come from 4 companies. The first decision was on October 27, 2005 and the most recent on March 15, 2018.
5AI devices
4Companies
2005First decision
2018-03-15Latest decision
Trend: devices per year
20052008201020122018
Top companies
Most common product codes
All 5 devices, newest first
- Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · Clinical Toxcicology
- TISSUE OF ORIGIN TEST KIT FFPEPATHWORK DIAGNOSTICS, INC. · Clinical Toxcicology
- PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPEPATHWORK DIAGNOSTICS · Clinical Toxcicology
- PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TESTPATHWORK DIAGNOSTICS, INC. · Clinical Toxcicology
- BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBIO-RAD LABORATORIES, INC. · Clinical Toxcicology
Frequently asked questions
How many FDA-cleared AI clinical toxcicology devices are there?
As of the FDA list updated through June 29, 2026, 5 AI-enabled devices have Clinical Toxcicology as their lead review panel (0.3% of the list).
Which companies have the most AI clinical toxcicology devices?
PATHWORK DIAGNOSTICS, INC. (2), Cancer Genetics, Inc. (1), PATHWORK DIAGNOSTICS (1) have the most AI-enabled clinical toxcicology devices on the FDA list.
Which year had the most AI clinical toxcicology authorizations?
2005 had the most, with 1 device.
Which FDA pathways are used for AI clinical toxcicology devices?
510(k): 5.
What was the most recent AI clinical toxcicology device on the list?
Tissue of Origin Test Kit-FFPE from Cancer Genetics, Inc. (K173839), with a decision dated March 15, 2018.