Cleared Traditional

K994165 - ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595

K994165 is an FDA 510(k) clearance for ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K994165

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.

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 102
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K994165.
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K993485 · Sun Biomedical Laboratories, Inc. · Dec 1999