FDA grants 510(k) clearance for clinical drug testing device

FDA clears Randox USA’s advanced drug testing panel to combat opioid crisis with more efficient drug screening.

Randox USA (WV, USA) has announced that the US Food and Drug Administration (FDA; MD, USA) has granted 510(k) clearance for the marketing of its latest clinical drug testing panel, integrated with the Evidence MultiSTAT, a fully automated multi-analyte analyzer powered by Randox’s proprietary Biochip Array Technology. For the bioanalytical and diagnostics industries, the clearance reinforces the shift toward multiplex, high-throughput testing platforms that improve efficiency, scalability and clinical value, while highlighting regulatory confidence in advanced biochip-based technologies and supporting efforts to combat the opioid epidemic and improve healthcare outcomes across the US.

Drug abuse remains a significant public health challenge, with both the US and Europe continuing to observe rises in synthetic opioids and novel psychoactive substances that are often missed in standard screens. The extensive detection panel developed by Randox, which detects both common and emerging drug classes including critical analytes such as fentanyl and 6-MAM, could help medical and forensic labs keep pace with evolving abuse patterns, reduce diagnostic uncertainty and enable prompt treatment. This capability is particularly significant in addressing the ongoing opioid crisis in the United States. While overdose fatalities reportedly declined by 27% in 2024, the misuse of prescription opioids and the rise of illicit drugs like heroin and synthetic opioids, including fentanyl, continue to drive overdose cases.

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The Evidence MultiSTAT is a compact, FDA-cleared immunoassay analyzer designed for on-site, simultaneous detection of multiple drug targets. Using chemiluminescence as its measurement principle, the analyzer delivers highly accurate results in minutes with minimal sample preparation. Designed to provide accurate, cost-effective and user-friendly drug screening solution, the analyzer’s broad cross-reactivity profile ensures reliable results, reducing the likelihood of false positives or negatives and improving patient care outcomes.

The newly approved panel is among the most advanced rapid drug testing systems available, capable of detecting 15 drugs of abuse simultaneously from urine samples in just 21 minutes. The system features a straightforward three-step testing process, pre-filled reagent cartridges and results with accuracy comparable to confirmatory methods – all features sought by clinicians and healthcare providers to enhance patient care pathways.

David Ferguson, Chief Operating Officer of Randox Health, commented:

“Trusted across multiple industries, with widespread adoption and notable placements benefiting forensic toxicology, our latest panel broadens access to drug testing across a wide range of clinical and critical care environments, including emergency departments, hospital laboratories, pain management services, behavioral and psychiatric centers, and the criminal justice system to reduce the negative impact on patient care.”