Cleared Traditional

K994164 - ONTRAK TESTSTIK 2 FOR COCAINE/THC

K994164 is the FDA 510(k) clearance for ONTRAK TESTSTIK 2 FOR COCAINE/THC by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K994164 · Roche Diagnostics Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
126d
Days
Class 2
Risk

K994164 is an FDA 510(k) clearance for the ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 K994164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date April 13, 2000
Days to Decision 126 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
39d slower than avg
Panel avg: 87d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 72
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K994164.
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · Princeton BioMeditech Corp. · May 2002
CANNABINOIDS
K013247 · Abbott Laboratories · Mar 2002
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461 · Dade Behring, Inc. · Apr 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · Syva Co. · Jan 2000
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701 · Roche Diagnostic Systems, Inc. · Dec 1998