Cleared Traditional

K924113 - ABUSCREEN ONLINE FOR COCAINE METABOLITE

K924113 is an FDA 510(k) clearance for ABUSCREEN ONLINE FOR COCAINE METABOLITE, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DLN cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K924113 · Roche Diagnostic Systems, Inc. · Toxicology device
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Dec 1992
Decision
137d
Days
Class 2
Risk

K924113 is an FDA 510(k) clearance for the ABUSCREEN ONLINE FOR COCAINE METABOLITE. Classified as Hemagglutination, Cocaine Metabolites (benzoylecgnonine) (product code DLN), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 137 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

FDA 510(k) Submission Details - K924113

510(k) Number K924113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date December 28, 1992
Days to Decision 137 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
50d slower than avg
Panel avg: 87d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLN Device Classification - Class 2, Special Controls

Product Code DLN Hemagglutination, Cocaine Metabolites (benzoylecgnonine)
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.