Cleared Traditional

K041144 - RANDOX OPIATES ASSAY

K041144 is an FDA 510(k) clearance for RANDOX OPIATES ASSAY, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K041144

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.

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 188
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K041144.
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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