Cleared Traditional

K992949 - SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST

K992949 is an FDA 510(k) clearance for SCREENERS MARIJUANA TEST, manufactured by Drug Detection Devices, Ltd.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K992949 · Drug Detection Devices, Ltd. · Toxicology device
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Dec 1999
Decision
117d
Days
Class 2
Risk

K992949 is an FDA 510(k) clearance for the SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Drug Detection Devices, Ltd. (Alpharetta, US). The FDA issued a Cleared decision on December 27, 1999 after a review of 117 days - within the typical 510(k) review window.

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 Drug Detection Devices, Ltd. devices

FDA 510(k) Submission Details - K992949

510(k) Number K992949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1999
Decision Date December 27, 1999
Days to Decision 117 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
30d slower than avg
Panel avg: 87d · This submission: 117d
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 K992949.
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)
K993961 · American Bio Medica Corp. · Jan 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · Syva Co. · Jan 2000
AT HOME DRUG TEST, MODEL 9078
K994220 · Phamatech · Dec 1999
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE
K993796 · American Bio Medica Corp. · Dec 1999
MICRO-STRIP FOR MARIJUANA METABOLITES
K991516 · Microdiagnostics, Inc. · Aug 1999
RAPIDONE - MARIJUANA TEST
K990818 · American Bio Medica Corp. · Jul 1999