Cleared Traditional

K994139 - FIRST CHECK HOME DRUG TEST PANEL 2

K994139 is the FDA 510(k) clearance for FIRST CHECK HOME DRUG TEST PANEL 2 by Worldwide Medical Corp.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K994139 · Worldwide Medical Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
199d
Days
Class 2
Risk

K994139 is an FDA 510(k) clearance for the FIRST CHECK HOME DRUG TEST PANEL 2. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Worldwide Medical Corp. (Washington, US). The FDA issued a Cleared decision on June 23, 2000 after a review of 199 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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. Standard predicate reliance. 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 K994139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1999
Decision Date June 23, 2000
Days to Decision 199 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
112d slower than avg
Panel avg: 87d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K994139.
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · Princeton BioMeditech Corp. · May 2002
CANNABINOIDS
K013247 · Abbott Laboratories · Mar 2002
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
K994410 · Alfa Scientific Designs, Inc. · Jun 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164 · Roche Diagnostics Corp. · Apr 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461 · Dade Behring, Inc. · Apr 2000