Clinical Toxicology— FDA advisory panel TX

Clinical toxicology covers drug and toxin testing: drugs-of-abuse screening assays (urine, oral fluid, and their instrumented readers), therapeutic drug monitoring assays for narrow-therapeutic-index medications, blood lead and heavy-metal tests, and breath and saliva alcohol analyzers. It is the IVD panel with the most workplace- and forensic-adjacent use, which gives its cleared devices an unusual dual life inside and outside clinical care.

The reading note that matters most here: a cleared drugs-of-abuse screen is, by design, a presumptive test — cutoff-based immunoassays cleared with the expectation of confirmatory laboratory methods behind them. The panel's clearance record also tracks drug-policy history at one remove: as prescribing patterns and public-health concerns shift (opioids and fentanyl most visibly), new assay targets and matrix types appear in the filings within a few years.