Cleared Traditional

K040198 - LABONE COCAINE METABOLITE MICRO-PLATE EIA

K040198 is the FDA 510(k) clearance for LABONE COCAINE METABOLITE MICRO-PLATE EIA by Labone, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K040198 · Labone, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
36d
Days
Class 2
Risk

K040198 is an FDA 510(k) clearance for the LABONE COCAINE METABOLITE MICRO-PLATE EIA. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Labone, Inc. (Lenexa, US). The FDA issued a Cleared decision on March 5, 2004 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 K040198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2004
Decision Date March 05, 2004
Days to Decision 36 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
51d faster than avg
Panel avg: 87d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 83
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K040198.
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