Cleared Traditional

Evidence MultiSTAT DOA Urine MultiPlex

K250741 · Randox Laboratories Limited · Toxicology
Jan 2026
Decision
318d
Days
Class 2
Risk

About This 510(k) Submission

K250741 is an FDA 510(k) clearance for the Evidence MultiSTAT DOA Urine MultiPlex, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on January 23, 2026, 318 days after receiving the submission on March 11, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K250741 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2025
Decision Date January 23, 2026
Days to Decision 318 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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