Cleared Traditional

TDX AMPHETAMINE/METHAMPHETAMINE II (K883707) - FDA 510(k) Clearance

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

K883707 · Abbott Laboratories · Chemistry device
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Oct 1988
Decision
51d
Days
Class 2
Risk

K883707 is an FDA 510(k) clearance for the TDX AMPHETAMINE/METHAMPHETAMINE II. 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 October 20, 1988 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - the FDA in vitro diagnostics and chemistry 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 Abbott Laboratories devices

Submission Details

510(k) Number K883707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1988
Decision Date October 20, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 Chemistry 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 K883707.
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K894465 · Roche Diagnostic Systems, Inc. · 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
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K884022 · Syva Co. · Oct 1988
EMIT HVA AMPHETAMINE ASSAY
K882589 · Syva Co. · Aug 1988
TDX (R) AMPHETAMINE CLASS
K874770 · Abbott Laboratories · Apr 1988