Cleared Traditional

K962411 - ONTRAK TESTCUP AMPHETAMINES

K962411 is an FDA 510(k) clearance for ONTRAK TESTCUP AMPHETAMINES, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K962411 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
108d
Days
Class 2
Risk

K962411 is an FDA 510(k) clearance for the ONTRAK TESTCUP AMPHETAMINES. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on October 7, 1996 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K962411

510(k) Number K962411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1996
Decision Date October 07, 1996
Days to Decision 108 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 87d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 176
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K962411.
QUIKPAC II ONE STEP AMPHETAMINE TEST
K971109 · Drial Consultants, Inc. · May 1997
QUICKPAC II ONE STEP METHAMPHETAMINE TEST
K970724 · Drial Consultants, Inc. · May 1997
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
K970265 · Drial Consultants, Inc. · Apr 1997
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000
K955934 · Biosite Incorporated · Feb 1996
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS
K955935 · Biosite Incorporated · Feb 1996
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115 · Abbott Laboratories · Oct 1995