FDA Product Code DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cocaine use disorder and acute intoxication require rapid laboratory confirmation. FDA product code DIO covers enzyme immunoassay systems for cocaine and cocaine metabolite detection.
These tests detect benzoylecgonine — the primary urinary metabolite of cocaine — in biological specimens. They are used in emergency toxicology screening, workplace drug testing, and substance abuse treatment monitoring.
DIO devices are Class II medical devices, regulated under 21 CFR 862.3250 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Microgenics Corporation, Carolina Liquid Chemistries Corp. and Immunalysis Corporation.
FDA 510(k) Cleared Enzyme Immunoassay, Cocaine And Cocaine Metabolites Devices (Product Code DIO)
About Product Code DIO - Regulatory Context
510(k) Submission Activity
145 total 510(k) submissions under product code DIO since 1984, with 145 receiving FDA clearance (average review time: 117 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
DIO devices are reviewed by the Toxicology panel. Browse all Toxicology devices →