Cleared Traditional

K933053 - ABUSCREEN ONLINE FOR COCAINE METABOLITE

K933053 is the FDA 510(k) clearance for ABUSCREEN ONLINE FOR COCAINE METABOLITE by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K933053 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1993
Decision
96d
Days
Class 2
Risk

K933053 is an FDA 510(k) clearance for the ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 30, 1993 after a review of 96 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K933053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date August 30, 1993
Days to Decision 96 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 87d · This submission: 96d
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

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