Cleared Traditional

K993852 - FIRST CHECK HOME DRUG TEST PANEL 4

K993852 is the FDA 510(k) clearance for FIRST CHECK HOME DRUG TEST PANEL 4 by Worldwide Medical Corp.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 383-day FDA review.

K993852 · Worldwide Medical Corp. · Toxicology device
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Nov 2000
Decision
383d
Days
Class 2
Risk

K993852 is an FDA 510(k) clearance for the FIRST CHECK HOME DRUG TEST PANEL 4. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Worldwide Medical Corp. (Washington, US). The FDA issued a Cleared decision on November 29, 2000 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Worldwide Medical Corp. devices

Submission Details

510(k) Number K993852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date November 29, 2000
Days to Decision 383 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
296d slower than avg
Panel avg: 87d · This submission: 383d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 32
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K993852.
MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
K003847 · Alfa Scientific Designs, Inc. · May 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · Microgenics Corp. · May 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836 · Phamatech · Apr 2001
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · Roche Diagnostics Corp. · Apr 2000
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
K000447 · Phamatech · Mar 2000
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · Syva Co. · Jan 2000