Cleared Traditional

K020869 - FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)

K020869 is an FDA 510(k) clearance for FIRST CHECK HOME DRUG TEST FOR MDMA (EC..., manufactured by Worldwide Medical Corp.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K020869 · Worldwide Medical Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
85d
Days
Class 2
Risk

K020869 is an FDA 510(k) clearance for the FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY). Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Worldwide Medical Corp. (Lake Forest, US). The FDA issued a Cleared decision on June 11, 2002 after a review of 85 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 Worldwide Medical Corp. devices

FDA 510(k) Submission Details - K020869

510(k) Number K020869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date June 11, 2002
Days to Decision 85 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
2d faster than avg
Panel avg: 87d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

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 185
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K020869.
SYVA EMIT II PLUS AMPHETAMINES ASSAY
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'RAPIDTEC' 5A MULTIPLE DIP TEST
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AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
K020395 · Lin-Zhi International, Inc. · Jun 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · Biosite Incorporated · Jun 2002
TRIAGE TOX DRUG SCREEN, CATALOG #94000
K012745 · Biosite Incorporated · Jan 2002