Cleared Traditional

K020869 - FIRST CHECK HOME DRUG TEST FOR MDMA (EC...

K020869 is the FDA 510(k) clearance for FIRST CHECK HOME DRUG TEST FOR MDMA (EC... by Worldwide Medical Corp.. It is a Class 2 Toxicology device (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

Submission Details

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.

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 K020869.
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SYVA EMIT II PLUS AMPHETAMINES ASSAY
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INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
K022564 · Alfa Scientific Designs, Inc. · Aug 2002
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