Cleared Traditional

K131168 - IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY

K131168 is the FDA 510(k) clearance for IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY by Immunalysis Corporation. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K131168 · Immunalysis Corporation · Toxicology device
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Jan 2014
Decision
268d
Days
Class 2
Risk

K131168 is an FDA 510(k) clearance for the IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on January 17, 2014 after a review of 268 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 Immunalysis Corporation devices

Submission Details

510(k) Number K131168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2013
Decision Date January 17, 2014
Days to Decision 268 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 87d · This submission: 268d
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 126
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K131168.
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
K141406 · Immunalysis Corporation · Jul 2014
LZI HYDROCODONE
K141055 · Lin-Zhi International, Inc. · Jun 2014
STATUS DS OXY
K130650 · Princeton BioMeditech Corp. · Feb 2014
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
OPIATE ENZYME IMMUNOASSAY
K110298 · Lin-Zhi International, Inc. · Jul 2011