Cleared Traditional

K013314 - OPIATES

K013314 is an FDA 510(k) clearance for OPIATES, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K013314 · Abbott Laboratories · Toxicology device
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Optimized for regulatory review, auditing and printing
Mar 2002
Decision
160d
Days
Class 2
Risk

K013314 is an FDA 510(k) clearance for the OPIATES. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 13, 2002 after a review of 160 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K013314

510(k) Number K013314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2001
Decision Date March 13, 2002
Days to Decision 160 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
73d slower than avg
Panel avg: 87d · This submission: 160d
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 149
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K013314.
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · Lin-Zhi International, Inc. · Jun 2002
UPLINK TEST SYSTEM
K020371 · OraSure Technologies, Inc. · Apr 2002
RAPIDONE-OXY TEST
K014101 · American Bio Medica Corp. · Mar 2002
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · Roche Diagnostics Corp. · Dec 2001
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
K013380 · ACON Laboratories, Inc. · Dec 2001
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353 · ACON Laboratories, Inc. · Jul 2001