Cleared Traditional

K000400 - SCREENERS AMPHETAMINE TEST

K000400 is the FDA 510(k) clearance for SCREENERS AMPHETAMINE TEST by Drug Detection Devices, Ltd.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K000400 · Drug Detection Devices, Ltd. · Toxicology device
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Apr 2000
Decision
71d
Days
Class 2
Risk

K000400 is an FDA 510(k) clearance for the SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Drug Detection Devices, Ltd. (Alpharetta, US). The FDA issued a Cleared decision on April 18, 2000 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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

Submission Details

510(k) Number K000400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2000
Decision Date April 18, 2000
Days to Decision 71 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
16d faster than avg
Panel avg: 87d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K000400.
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
K001225 · Princeton BioMeditech Corp. · May 2000
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
K000606 · Beckman Coulter, Inc. · May 2000
CEDIA DAU AMPHASSURE ASSAY
K994380 · Microgenics Corp. · May 2000
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
K000460 · Dade Behring, Inc. · Apr 2000
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
K992632 · Diagnostic Products Corp. · Jan 2000
AT HOME DRUG TEST, MODEL 9063
K994237 · Phamatech · Dec 1999