Cleared Traditional

TDX AMPHETAMINE METHAMPHETAMINE (K853879) - FDA 510(k) Clearance

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

K853879 · Abbott Laboratories · Chemistry device
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Oct 1985
Decision
40d
Days
Class 2
Risk

K853879 is an FDA 510(k) clearance for the TDX AMPHETAMINE METHAMPHETAMINE. 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 28, 1985 after a review of 40 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 K853879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1985
Decision Date October 28, 1985
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 K853879.
LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY
K873755 · Diagnostic Products Corp. · Oct 1987
ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH
K873622 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1987
DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5
K871696 · Diagnostic Products Corp. · Jun 1987
EMIT D.A.U. AMPHETAMINE ASSAY
K842674 · Syva Co. · Sep 1984
EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT
K843458 · Syva Co. · Sep 1984
MODIF. OF EMIT URINE AMPHETAMINE
K833579 · Syva Co. · Jan 1984