Cleared Traditional

K912758 - ABUSCREEN ONLINE FOR AMPHETAMINES

K912758 is the FDA 510(k) clearance for ABUSCREEN ONLINE FOR AMPHETAMINES by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K912758 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1991
Decision
35d
Days
Class 2
Risk

K912758 is an FDA 510(k) clearance for the ABUSCREEN ONLINE FOR AMPHETAMINES. 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 July 26, 1991 after a review of 35 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 K912758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1991
Decision Date July 26, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 87d · This submission: 35d
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 K912758.
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
K920507 · Syva Co. · Feb 1992
IL TEST(TM) AMPHETAMINE
K913738 · Instrumentation Laboratory CO · Nov 1991
BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE
K914146 · Biosite Incorporated · Oct 1991
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
K910278 · Roche Diagnostic Systems, Inc. · Apr 1991
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
K910658 · Roche Diagnostic Systems, Inc. · Apr 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756 · Roche Diagnostic Systems, Inc. · Mar 1991