Cleared Traditional

K092258 - RANDOX METABOLITE (EDDP) ASSAY

K092258 is the FDA 510(k) clearance for RANDOX METABOLITE (EDDP) ASSAY by Randox Laboratories, Ltd.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K092258 · Randox Laboratories, Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 47
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K092258.
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K151395 · Immunalysis Corporation · Jul 2015
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
K131232 · Guangzhou Wondfo Biotech Co., Ltd. · May 2013
RANDOX METHADONE ASSAY
K092272 · Randox Laboratories, Ltd. · Nov 2010
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K092048 · Biosite Incorporated · Apr 2010
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
K081378 · Thermo Fisher Scientific · Jan 2009
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
K062637 · Ortho-Clinical Diagnostics, Inc. · Nov 2006