Cleared Traditional

K963918 - IMMULITE COCAINE METABOLITE

K963918 is an FDA 510(k) clearance for IMMULITE COCAINE METABOLITE, manufactured by Diagnostic Products Corp.. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K963918 · Diagnostic Products Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
190d
Days
Class 2
Risk

K963918 is an FDA 510(k) clearance for the IMMULITE COCAINE METABOLITE. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 8, 1997 after a review of 190 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K963918

510(k) Number K963918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date April 08, 1997
Days to Decision 190 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 87d · This submission: 190d
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 109
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K963918.
AQ ONE STEP COCAINE TEST
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QUIKSTRIP ONE STEP COCAINE TEST
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RAPID DRUG SCREEN
K964900 · American Bio Medica Corp. · Apr 1997
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
K962353 · Princeton BioMeditech Corp. · Aug 1996
COCAINE METABOLITE EIA TEST
K960187 · Diagnostic Reagents, Inc. · Apr 1996
FRONTLINE COCAINE
K954496 · Boehringer Mannheim Corp. · Mar 1996