Cleared Traditional

K863843 - COCAINE METABOLITE ROCHE(R) EIA

K863843 is an FDA 510(k) clearance for COCAINE METABOLITE ROCHE EIA, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K863843

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.

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 111
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K863843.
LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE
K873751 · Diagnostic Products Corp. · Oct 1987
LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY
K873752 · Diagnostic Products Corp. · Oct 1987
COCAINE METABOLITE ENZYME IMMUNOASSAY KIT
K871305 · General Diagnostics · Jun 1987
TDX COCAINE METABOLITE
K854163 · Abbott Laboratories · Nov 1985
EMIT D.A.U. COCAINE ASSAY
K843556 · Syva Co. · Oct 1984
EMIT 700 COCAINE METABOLITE ASSAY
K843160 · Syva Co. · Aug 1984