Cleared Traditional

K935042 - ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT

K935042 is the FDA 510(k) clearance for ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K935042 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jan 1994
Decision
96d
Days
Class 2
Risk

K935042 is an FDA 510(k) clearance for the ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT. 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 January 25, 1994 after a review of 96 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 K935042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1993
Decision Date January 25, 1994
Days to Decision 96 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
9d slower than avg
Panel avg: 87d · This submission: 96d
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 K935042.
ABUSIGN DOA4
K943439 · Princeton BioMeditech Corp. · Feb 1995
CEDIA DAU AMPHETAMINES ASSAY
K943993 · Microgenics Corp. · Oct 1994
CEDIA DAU AMPHETAMINES ASSAY
K941372 · Microgenics Corp. · Jul 1994
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