Cleared Traditional

K874080 - REVISED LABELING FOR SYVA AMPHETAMINE A...

K874080 is the FDA 510(k) clearance for REVISED LABELING FOR SYVA AMPHETAMINE A... by Syva Co.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K874080 · Syva Co. · Toxicology device
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Oct 1987
Decision
23d
Days
Class 2
Risk

K874080 is an FDA 510(k) clearance for the REVISED LABELING FOR SYVA AMPHETAMINE ASSAY. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on October 29, 1987 after a review of 23 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 Syva Co. devices

Submission Details

510(k) Number K874080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1987
Decision Date October 29, 1987
Days to Decision 23 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
64d faster than avg
Panel avg: 87d · This submission: 23d
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 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K874080.
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
K874486 · Abbott Laboratories · Nov 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
K874273 · Roche Diagnostic Systems, Inc. · Nov 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
K874274 · Roche Diagnostic Systems, Inc. · Nov 1987
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