Cleared Traditional

K033601 - LABONE MICRO-PLATE COTININE EIA

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

K033601 · Labone, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K033601

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
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. Third-party reviewed.

DLJ Device Classification - Class 2, Special Controls

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 Consultant

Tuv America, Inc.
LAURA DANIELSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 122
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K033601.
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DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
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
K033601 · LABONE MICRO-PLATE COTININE EIA
Download PDF FDA Summary Labone, Inc.