Cleared Traditional

K040411 - DRI OXYCODONE ASSAY

K040411 is an FDA 510(k) clearance for DRI OXYCODONE ASSAY, manufactured by Microgenics Corp.. The device is a Class 1 Toxicology device with product code LAS cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K040411 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
99d
Days
Class 1
Risk

K040411 is an FDA 510(k) clearance for the DRI OXYCODONE ASSAY. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on May 27, 2004 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Microgenics Corp. devices

FDA 510(k) Submission Details - K040411

510(k) Number K040411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2004
Decision Date May 27, 2004
Days to Decision 99 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
12d slower than avg
Panel avg: 87d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

LAS Device Classification - Class 1, General Controls

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LAS Drug Specific Control Materials

All 69
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K040411.
MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
K072257 · More Diagnostics · Jan 2008
QUANTIMETRIX NICOSURE COTININE URINE CONTROL
K062942 · Quantimetrix Corp. · Oct 2006
MAS IMMUNOSUPPRESSANT CONTROLS
K051074 · Microgenics Corp. · Jun 2005
MICROGENICS CYCLOSPORINE CONTROL KIT
K032842 · Microgenics Corp. · Oct 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616 · Microgenics Corp. · Mar 2003
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
K992151 · Consolidated Technologies, Inc. · Jul 1999