Cleared Traditional

TDX (R) AMPHETAMINE CLASS (K874770) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 77
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