Cleared Traditional

K994138 - FIRST CHECK HOME DRUG TEST PANEL 3

K994138 is an FDA 510(k) clearance for FIRST CHECK HOME DRUG TEST PANEL 3, manufactured by Worldwide Medical Corp.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K994138 · Worldwide Medical Corp. · Toxicology device
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Jun 2000
Decision
199d
Days
Class 2
Risk

K994138 is an FDA 510(k) clearance for the FIRST CHECK HOME DRUG TEST PANEL 3. 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

FDA 510(k) Submission Details - K994138

510(k) Number K994138 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
Combination Product No
PCCP Authorized No
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.

LDJ Device Classification - Class 2, Special Controls

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 124
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K994138.
PROFILE II ER
K010138 · Medtox Diagnostics, Inc. · Feb 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375 · OraSure Technologies, Inc. · Jan 2001
FIRST CHECK HOME DRUG TEST (THC)
K993663 · Worldwide Medical Corp. · Jun 2000
FIRST CHECK HOME DRUG TEST PANEL 2
K994139 · Worldwide Medical Corp. · Jun 2000
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