Cleared Traditional

K874770 - TDX AMPHETAMINE CLASS

K874770 is an FDA 510(k) clearance for TDX AMPHETAMINE CLASS, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K874770 · Abbott Laboratories · Toxicology device
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Apr 1988
Decision
154d
Days
Class 2
Risk

K874770 is an FDA 510(k) clearance for the TDX (R) AMPHETAMINE CLASS. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 154 days - an extended review 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K874770

510(k) Number K874770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date April 21, 1988
Days to Decision 154 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
67d slower than avg
Panel avg: 87d · This submission: 154d
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 140
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K874770.
TDX AMPHETAMINE/METHAMPHETAMINE II
K883707 · Abbott Laboratories · Oct 1988
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K884022 · Syva Co. · Oct 1988
EMIT HVA AMPHETAMINE ASSAY
K882589 · Syva Co. · Aug 1988
REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.
K880013 · Abbott Laboratories · Mar 1988
ABUSCREEN(R) EIA AMPHETAMINE
K874836 · Roche Diagnostic Systems, Inc. · Feb 1988
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
K874486 · Abbott Laboratories · Nov 1987