Cleared Traditional

K250741 - Evidence MultiSTAT DOA Urine MultiPlex

K250741 is an FDA 510(k) clearance for Evidence MultiSTAT DOA Urine MultiPlex, manufactured by Randox Laboratories Limited. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 318-day FDA review.

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

K250741 is an FDA 510(k) clearance for the Evidence MultiSTAT DOA Urine MultiPlex. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on January 23, 2026 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Randox Laboratories Limited devices

FDA 510(k) Submission Details - K250741

510(k) Number K250741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 87d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 149
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K250741.
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