Cleared Traditional

K933052 - ABUSCREEN ONLINE FOR AMPHETAMINES

K933052 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 112-day FDA review.

K933052 · Roche Diagnostic Systems, Inc. · Toxicology device
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Sep 1993
Decision
112d
Days
Class 2
Risk

K933052 is an FDA 510(k) clearance for the ABUSCREEN ONLINE(R) 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 September 15, 1993 after a review of 112 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

Submission Details

510(k) Number K933052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date September 15, 1993
Days to Decision 112 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
25d slower than avg
Panel avg: 87d · This submission: 112d
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 K933052.
CEDIA DAU AMPHETAMINES ASSAY
K941372 · Microgenics Corp. · Jul 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
K935042 · Roche Diagnostic Systems, Inc. · Jan 1994
AMPHETAMINES EIA ASSAY MODIFICATION
K934891 · Diagnostic Reagents, Inc. · Jan 1994
THE TRIAGE II
K924476 · Biosite Incorporated · Jan 1993
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
K921998 · Roche Diagnostic Systems, Inc. · May 1992
AMPHETAMINES EIA TEST
K921554 · Diagnostic Reagents, Inc. · May 1992