Cleared Traditional

RANDOX METABOLITE (EDDP) ASSAY (K092258) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092258 · Randox Laboratories, Ltd. · Toxicology device
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Nov 2010
Decision
469d
Days
Class 2
Risk

K092258 is an FDA 510(k) clearance for the RANDOX METABOLITE (EDDP) ASSAY. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on November 9, 2010 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K092258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2009
Decision Date November 09, 2010
Days to Decision 469 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
382d slower than avg
Panel avg: 87d · This submission: 469d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 62
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K092258.
LZI Methadone II Enzyme Immunoassay
K192433 · Lin-Zhi International, Inc. · Oct 2019
ARK EDDP Assay
K182779 · ARK Diagnostics, Inc. · Nov 2018
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
K170416 · Lin-Zhi International, Inc. · Jun 2017
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K151395 · Immunalysis Corporation · Jul 2015
METHADONE
K013001 · Abbott Laboratories · Mar 2002
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
K000466 · Dade Behring, Inc. · Apr 2000