Cleared Traditional

K043507 - ACON OXY II ONE STEP OXYCODONE TEST STRIP

Also marketed or referenced as:
TEST DEVICE

K043507 is the FDA 510(k) clearance for ACON OXY II ONE STEP OXYCODONE TEST STRIP by ACON Laboratories, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K043507 · ACON Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
67d
Days
Class 2
Risk

K043507 is an FDA 510(k) clearance for the ACON OXY II ONE STEP OXYCODONE TEST STRIP. 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 February 25, 2005 after a review of 67 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 K043507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2004
Decision Date February 25, 2005
Days to Decision 67 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
20d faster than avg
Panel avg: 87d · This submission: 67d
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 K043507.
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE
K060466 · ACON Laboratories, Inc. · Apr 2006
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · Immunalysis Corporation · Oct 2005
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
K050733 · Lin-Zhi International, Inc. · Jun 2005
RANDOX OPIATES ASSAY
K041144 · Randox Laboratories, Ltd. · Nov 2004
CEDIA BUPRENORPHINE ASSAY
K040316 · Microgenics Corp. · Jun 2004
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
K040274 · ACON Laboratories, Inc. · May 2004