Cleared Traditional

K994164 - ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579

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

K994164 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K994164

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.

LDJ Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K994164.
PROFILE II ER
K010138 · Medtox Diagnostics, Inc. · Feb 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375 · OraSure Technologies, Inc. · Jan 2001
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
K994410 · Alfa Scientific Designs, Inc. · Jun 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461 · Dade Behring, Inc. · Apr 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131 · Phamatech · Feb 2000
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)
K993961 · American Bio Medica Corp. · Jan 2000