Cleared Traditional

K883105 - EZ-SCREEN CANNABINOID/COCAINE

K883105 is an FDA 510(k) clearance for EZ-SCREEN CANNABINOID/COCAINE, manufactured by Environmental Diagnostics, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K883105

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.

DIO Device Classification - Class 2, Special Controls

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 120
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