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.

The panel was developed to offer accuracy in results, be cost-effective, and provide easy-to-use testing for efficient drug screening with an extensive cross-reactivity profile, reducing the negative impact on patient care.

The panel provides simultaneous detection of 15 drugs of abuse from urine in 21 minutes, with a simple 3 step testing process and pre-filled reagent cartridges.

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