Cleared Traditional

K933052 - ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED

K933052 is an FDA 510(k) clearance for ABUSCREEN ONLINE 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 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

FDA 510(k) Submission Details - K933052

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.

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 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
SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY
K931498 · Solarcare Technologies Corp,Inc. · Jul 1993
STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA
K930690 · Solarcare Technologies Corp,Inc. · Apr 1993
THE TRIAGE II
K924476 · Biosite Incorporated · Jan 1993