Cleared Traditional

K934891 - AMPHETAMINES EIA ASSAY MODIFICATION

K934891 is an FDA 510(k) clearance for AMPHETAMINES EIA ASSAY MODIFICATION, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K934891 · Diagnostic Reagents, Inc. · Toxicology device
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Jan 1994
Decision
114d
Days
Class 2
Risk

K934891 is an FDA 510(k) clearance for the AMPHETAMINES EIA ASSAY MODIFICATION. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on January 13, 1994 after a review of 114 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 Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K934891

510(k) Number K934891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1993
Decision Date January 13, 1994
Days to Decision 114 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
27d slower than avg
Panel avg: 87d · This submission: 114d
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 186
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K934891.
CEDIA DAU AMPHETAMINES ASSAY
K943993 · Microgenics Corp. · Oct 1994
CEDIA DAU AMPHETAMINES ASSAY
K941372 · Microgenics Corp. · Jul 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
K935042 · Roche Diagnostic Systems, Inc. · Jan 1994
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
K933052 · Roche Diagnostic Systems, Inc. · Sep 1993
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