Cleared Traditional

K973075 - ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON

K973075 is an FDA 510(k) clearance for ONTRAK TESTSTIK FOR 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 52-day FDA review.

K973075 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
52d
Days
Class 2
Risk

K973075 is an FDA 510(k) clearance for the ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTI.... Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 9, 1997 after a review of 52 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K973075

510(k) Number K973075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1997
Decision Date October 09, 1997
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 87d · This submission: 52d
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 K973075.
STC METHAMPHETAMINE MICRO-PLATE EIA
K972989 · OraSure Technologies, Inc. · Jan 1998
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
K973784 · Biosite Incorporated · Dec 1997
FINGERPRINT DRUG SCREENING DEVICE
K973726 · Applied Technology Ventures, LLC · Nov 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
K972891 · Roche Diagnostic Systems, Inc. · Oct 1997
VISUALINE II METHAMPHETIMINE
K972032 · Sun Biomedical Laboratories, Inc. · Aug 1997
QUIKSTRIP ONE STEP METHAMPHETAMINE
K970395 · Drial Consultants, Inc. · Jun 1997