Cleared Traditional

K994165 - ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC

K994165 is the FDA 510(k) clearance for ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K994165 · Roche Diagnostics Corp. · Toxicology device
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Apr 2000
Decision
120d
Days
Class 2
Risk

K994165 is an FDA 510(k) clearance for the ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 7, 2000 after a review of 120 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 Diagnostics Corp. devices

Submission Details

510(k) Number K994165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date April 07, 2000
Days to Decision 120 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
33d slower than avg
Panel avg: 87d · This submission: 120d
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 64
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K994165.
COCAINE
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URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000467 · Dade Behring, Inc. · Apr 2000
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
K993988 · Syva Co. · Jan 2000
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
K983697 · Roche Diagnostic Systems, Inc. · Dec 1998
ONTRAK TESTCUP-ER
K983388 · Roche Diagnostic Systems, Inc. · Nov 1998