Cleared Traditional

K113747 - RANDOX OPIATES ASSAY

K113747 is an FDA 510(k) clearance for RANDOX OPIATES ASSAY, manufactured by Randox Laboratories Limited. The device is a Class 2 Chemistry device with product code DJG cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K113747 · Randox Laboratories Limited · Chemistry device
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Aug 2012
Decision
248d
Days
Class 2
Risk

K113747 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 Limited (Crumlin, GB). The FDA issued a Cleared decision on August 24, 2012 after a review of 248 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Randox Laboratories Limited devices

FDA 510(k) Submission Details - K113747

510(k) Number K113747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2011
Decision Date August 24, 2012
Days to Decision 248 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 88d · This submission: 248d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 150
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K113747.
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
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LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
K120763 · Lin-Zhi International, Inc. · Jun 2012
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
K120761 · Lin-Zhi International, Inc. · May 2012
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
K113624 · Guangzhou Wondfo Biotech Co., Ltd. · Mar 2012