Cleared Traditional

K883105 - EZ-SCREEN CANNABINOID/COCAINE

K883105 is the FDA 510(k) clearance for EZ-SCREEN CANNABINOID/COCAINE by Environmental Diagnostics, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K883105 · Environmental Diagnostics, Inc. · Toxicology device
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Dec 1988
Decision
144d
Days
Class 2
Risk

K883105 is an FDA 510(k) clearance for the EZ-SCREEN CANNABINOID/COCAINE. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Environmental Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on December 16, 1988 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 Environmental Diagnostics, Inc. devices

Submission Details

510(k) Number K883105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1988
Decision Date December 16, 1988
Days to Decision 144 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 87d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 83
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K883105.
ADX COCAINE METABOLITE
K890788 · Abbott Laboratories · Aug 1989
ABUSCREEN FP BUFFER REAGENT
K890883 · Roche Diagnostic Systems, Inc. · Mar 1989
ABUSCREEN FP FOR COCAINE METABOLITE
K890885 · Roche Diagnostic Systems, Inc. · Mar 1989
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
K881815 · Roche Diagnostic Systems, Inc. · Jul 1988
EMIT HVA COCAINE METABOLITE ASSAY
K881942 · Syva Co. · Jul 1988
REVISED LABELING FOR ADX COCAINE METABOLITE
K880009 · Abbott Laboratories · Mar 1988