Randox Receives FDA 510(K) Clearance for Clinical Drug Testing Device
Randox USA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for marketing its newest clinical drug testing panel. Available on the Evidence MultiSTAT, fully automated multi‑analyte analyzer, powered by patented Biochip Technology. Developed to offer accuracy in results, cost-effective and an easy-to-use testing for efficient drug screening with an extensive cross-reactivity profile, reducing the negative impact on patient care.
The most advanced rapid testing panel available on the market, providing simultaneous detection of 15 drugs of abuse from urine in 21 minutes. With a simple 3 step testing process, pre-filled reagent cartridges and results with very high accuracy comparable to confirmatory methods, the Evidence MultiSTAT gives clinicians and healthcare systems the quality they require to better patient clinical pathways.
As leaders in toxicology testing, Randox provides the detection of common and novel drug classes with the most extensive test menus available covering analytes such as fentanyl and 6‑MAM. This breadth of capability sets Randox apart, supporting efforts to address illicit drug use and excessive use of prescription medicine across the US amid a severe opioid crisis. Although overdose fatalities were reported to have declined by nearly 27% in 2024, many individuals first encountered opioids through legitimate prescriptions. Over time, however, a significant shift has occurred toward illicit substances including heroin and highly potent synthetic opioids like fentanyl, which continue to be the primary contributors to overdose cases today.
David Ferguson, Chief Operating Officer, 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, behavioural and psychiatric centres, and the criminal justice system to reduce the negative impact on patient care.”
Drug Panel
| Analyte | Analyte in Cut Off Material | Cut Off |
|---|---|---|
| Methamphetamine | S-(+)-Methamphetamine | 500ng/ml |
| Noroxycodone | Noroxycodone | 100ng/ml |
| Benzodiazepines I | Oxazepam | 200ng/ml |
| Methadone | (+)-Methadone | 300ng/ml |
| Phenobarbital | Phenobarbital | 200ng/ml |
| Tramadol | Tramadol | 200ng/ml |
| Phencyclidine | Phencyclidine | 25ng/ml |
| Buprenorphine | Norbuprenorphine | 5ng/ml |
| 6-Acetylmorphine | 6-Acetylmorphine | 10ng/ml |
| Fentanyl | Fentanyl | 1ng/ml |
| Benzodiazepines 2 | Lorazepam | 200ng/ml |
| Opiates | Morphine | 300ng/ml |
| Benzoylecgonine/Cocaine | Benzoylecgonine | 150ng/ml |
| Cannabinoids (THC) | (-)-11-nor-9-Carboxy-Δ9-THC | 50ng/ml |
| Amphetamine | S-(+)-Amphetamine | 500ng/ml |
About the Evidence MultiSTAT
The Evidence MultiSTAT, which is also FDA cleared, is an easy to use, small footprint, cartridge based, real immunoassay analyzer facilitating on-site simultaneous detection of multiple drug targets.
Using chemiluminescence as a measurement principle, the Evidence MultiSTAT consistently delivers accurate results.
With minimal sample preparation required, this versatile benchtop analyzer can achieve accurate, results in minutes with minimal risk of human error or cross contamination.