FDA Product Code JXM: Enzyme Immunoassay, Benzodiazepine
Benzodiazepine detection is essential in forensic toxicology, emergency medicine, and addiction treatment monitoring. FDA product code JXM covers enzyme immunoassay systems for benzodiazepine detection.
These tests use antibody-based technology to screen for benzodiazepines — including diazepam, lorazepam, and clonazepam — in urine and other biological specimens. They are widely used as initial screening tools before confirmatory chromatographic testing.
JXM devices are Class II medical devices, regulated under 21 CFR 862.3170 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Microgenics Corporation, Healgen Scientific, LLC and Immunalysis Corporation.
FDA 510(k) Cleared Enzyme Immunoassay, Benzodiazepine Devices (Product Code JXM)
About Product Code JXM - Regulatory Context
510(k) Submission Activity
90 total 510(k) submissions under product code JXM since 1979, with 90 receiving FDA clearance (average review time: 87 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under JXM have taken an average of 29 days to reach a decision - down from 88 days historically, suggesting improved FDA processing for this classification.
JXM devices are reviewed by the Toxicology panel. Browse all Toxicology devices →