Cleared Traditional

K910658 - ABUSCREEN ONTRAK FOR METHAMPHETAMINE

K910658 is the FDA 510(k) clearance for ABUSCREEN ONTRAK FOR METHAMPHETAMINE by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K910658 · Roche Diagnostic Systems, Inc. · Toxicology device
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Apr 1991
Decision
48d
Days
Class 2
Risk

K910658 is an FDA 510(k) clearance for the ABUSCREEN ONTRAK FOR METHAMPHETAMINE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on April 3, 1991 after a review of 48 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

Submission Details

510(k) Number K910658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1991
Decision Date April 03, 1991
Days to Decision 48 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 87d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 124
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K910658.
BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE
K914146 · Biosite Incorporated · Oct 1991
ABUSCREEN ONLINE FOR AMPHETAMINES
K912758 · Roche Diagnostic Systems, Inc. · Jul 1991
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
K910278 · Roche Diagnostic Systems, Inc. · Apr 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756 · Roche Diagnostic Systems, Inc. · Mar 1991
HYCOR ACCUPINCH METHAMPHETAMINE TEST
K904115 · Hycor Biomedical, Inc. · Nov 1990
MILENIA (TM) METHAMPHETAMINE
K904451 · Diagnostic Products Corp. · Nov 1990