Cleared Traditional

K863843 - COCAINE METABOLITE ROCHE EIA

K863843 is the FDA 510(k) clearance for COCAINE METABOLITE ROCHE EIA by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K863843 · Roche Diagnostic Systems, Inc. · Toxicology device
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Mar 1987
Decision
166d
Days
Class 2
Risk

K863843 is an FDA 510(k) clearance for the COCAINE METABOLITE ROCHE(R) EIA. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 166 days - an extended review cycle.

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 K863843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1986
Decision Date March 16, 1987
Days to Decision 166 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 87d · This submission: 166d
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 80
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K863843.
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