Cleared Traditional

K000452 - SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST

K000452 is an FDA 510(k) clearance for SCREENERS METHAMPHETAMINE TEST, manufactured by Drug Detection Devices, Ltd.. The device is a Class 2 Toxicology device with product code LAF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K000452 · Drug Detection Devices, Ltd. · Toxicology device
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Apr 2000
Decision
73d
Days
Class 2
Risk

K000452 is an FDA 510(k) clearance for the SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Drug Detection Devices, Ltd. (Alpharetta, US). The FDA issued a Cleared decision on April 24, 2000 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 Drug Detection Devices, Ltd. devices

FDA 510(k) Submission Details - K000452

510(k) Number K000452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2000
Decision Date April 24, 2000
Days to Decision 73 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
14d faster than avg
Panel avg: 87d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAF Device Classification - Class 2, Special Controls

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 40
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K000452.
AT WORK DRUG TEST, MODEL 9147T AWT
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QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
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SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · Syva Co. · Jan 2000