Cleared Traditional

K921998 - ABUSCREEN ONLINE(TM) FOR AMPHETAMINES

K921998 is the FDA 510(k) clearance for ABUSCREEN ONLINE(TM) 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 33-day FDA review.

K921998 · Roche Diagnostic Systems, Inc. · Toxicology device
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May 1992
Decision
33d
Days
Class 2
Risk

K921998 is an FDA 510(k) clearance for the ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED. 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 May 26, 1992 after a review of 33 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 K921998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1992
Decision Date May 26, 1992
Days to Decision 33 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
54d faster than avg
Panel avg: 87d · This submission: 33d
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 K921998.
AMPHETAMINES EIA ASSAY MODIFICATION
K934891 · Diagnostic Reagents, Inc. · Jan 1994
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
K933052 · Roche Diagnostic Systems, Inc. · Sep 1993
THE TRIAGE II
K924476 · Biosite Incorporated · Jan 1993
AMPHETAMINES EIA TEST
K921554 · Diagnostic Reagents, Inc. · May 1992
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
K920507 · Syva Co. · Feb 1992
IL TEST(TM) AMPHETAMINE
K913738 · Instrumentation Laboratory CO · Nov 1991