Cleared Traditional

K040274 - ACON OPI ONE STEP OPIATE TEST STRIP AND...

K040274 is the FDA 510(k) clearance for ACON OPI ONE STEP OPIATE TEST STRIP AND... by ACON Laboratories, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K040274 · ACON Laboratories, Inc. · Toxicology device
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May 2004
Decision
88d
Days
Class 2
Risk

K040274 is an FDA 510(k) clearance for the ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 3, 2004 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all ACON Laboratories, Inc. devices

Submission Details

510(k) Number K040274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2004
Decision Date May 03, 2004
Days to Decision 88 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
1d slower than avg
Panel avg: 87d · This submission: 88d
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 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K040274.
ACON OXY II ONE STEP OXYCODONE TEST STRIP
K043507 · ACON Laboratories, Inc. · Feb 2005
RANDOX OPIATES ASSAY
K041144 · Randox Laboratories, Ltd. · Nov 2004
CEDIA BUPRENORPHINE ASSAY
K040316 · Microgenics Corp. · Jun 2004
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE
K033047 · ACON Laboratories, Inc. · Feb 2004
SYNCHRON SYSTEMS OPIATE REAGENT
K031002 · Beckman Coulter, Inc. · Apr 2003
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · Lin-Zhi International, Inc. · Jun 2002