Cleared Traditional

K033601 - LABONE MICRO-PLATE COTININE EIA

K033601 is the FDA 510(k) clearance for LABONE MICRO-PLATE COTININE EIA by Labone, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K033601 · Labone, Inc. · Toxicology device
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Feb 2004
Decision
88d
Days
Class 2
Risk

K033601 is an FDA 510(k) clearance for the LABONE MICRO-PLATE COTININE EIA. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Labone, Inc. (Lenexa, US). The FDA issued a Cleared decision on February 10, 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 862.3200 - 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 Labone, Inc. devices

Submission Details

510(k) Number K033601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2003
Decision Date February 10, 2004
Days to Decision 88 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
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. Third-party reviewed.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DLJ Calibrators, Drug Specific

All 94
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K033601.
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K052015 · Dade Behring, Inc. · Sep 2005
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · Roche Diagnostics Corp. · Dec 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
K033165 · Roche Diagnostics Corp. · Oct 2003
DRI PRIMIDONE CALIBRATORS
K023780 · Microgenics Corp. · Feb 2003