Cleared Traditional

K041144 - RANDOX OPIATES ASSAY

K041144 is the FDA 510(k) clearance for RANDOX OPIATES ASSAY by Randox Laboratories, Ltd.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K041144 · Randox Laboratories, Ltd. · Toxicology device
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Nov 2004
Decision
187d
Days
Class 2
Risk

K041144 is an FDA 510(k) clearance for the RANDOX OPIATES ASSAY. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on November 3, 2004 after a review of 187 days - an extended review cycle.

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. Standard predicate reliance. 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, Ltd. devices

Submission Details

510(k) Number K041144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2004
Decision Date November 03, 2004
Days to Decision 187 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 87d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K041144.
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · Immunalysis Corporation · Oct 2005
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
K050733 · Lin-Zhi International, Inc. · Jun 2005
ACON OXY II ONE STEP OXYCODONE TEST STRIP
K043507 · ACON Laboratories, Inc. · Feb 2005
CEDIA BUPRENORPHINE ASSAY
K040316 · Microgenics Corp. · Jun 2004
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
K040274 · ACON Laboratories, Inc. · May 2004
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE
K033047 · ACON Laboratories, Inc. · Feb 2004