Cleared Traditional

K894465 - ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPH...

K894465 is the FDA 510(k) clearance for ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPH... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K894465 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1989
Decision
26d
Days
Class 2
Risk

K894465 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 26 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 K894465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date August 15, 1989
Days to Decision 26 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 87d · This submission: 26d
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 K894465.
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · Roche Diagnostic Systems, Inc. · Mar 1990
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
K895210 · Abbott Laboratories · Sep 1989
ADX AMPHETAMINE/METHAMPHEAMINE
K890692 · Abbott Laboratories · Aug 1989
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K894404 · Syva Co. · Aug 1989
ABUSCREEN FP FOR AMPHETAMINE
K890886 · Roche Diagnostic Systems, Inc. · Mar 1989
TDX AMPHETAMINE/METHAMPHETAMINE II
K883707 · Abbott Laboratories · Oct 1988