Cleared Traditional

K013482 - ABUSCREEN ONLINE OPIATES 300 / 2000

K013482 is the FDA 510(k) clearance for ABUSCREEN ONLINE OPIATES 300 / 2000 by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K013482 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
63d
Days
Class 2
Risk

K013482 is an FDA 510(k) clearance for the ABUSCREEN ONLINE OPIATES 300 / 2000. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 63 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K013482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2001
Decision Date December 21, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 87d · This submission: 63d
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 107
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K013482.
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
OPIATES
K013314 · Abbott Laboratories · Mar 2002
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
DRIDAU OPIATE ASSAY
K011150 · Microgenics Corp. · Jun 2001