Cleared Traditional

K000096 - ONTRAK TESTSTIK FOR METHAMPHETAMINE

K000096 is the FDA 510(k) clearance for ONTRAK TESTSTIK FOR METHAMPHETAMINE by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K000096 · Roche Diagnostics Corp. · Toxicology device
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Apr 2000
Decision
104d
Days
Class 2
Risk

K000096 is an FDA 510(k) clearance for the ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 26, 2000 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 K000096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2000
Decision Date April 26, 2000
Days to Decision 104 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
17d slower than avg
Panel avg: 87d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 20
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K000096.
AMPHETAMINE/METHAMPHETAMINE
K012998 · Abbott Laboratories · Mar 2002
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
K011672 · ACON Laboratories, Inc. · Jul 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · Microgenics Corp. · May 2001
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · Syva Co. · Jan 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
K992634 · Diagnostic Products Corp. · Jan 2000
ACCUSIGN MET/BIOSIGN MET
K961249 · Princeton BioMeditech Corp. · Apr 1996