Cleared Traditional

K833579 - MODIF. OF EMIT URINE AMPHETAMINE

K833579 is the FDA 510(k) clearance for MODIF. OF EMIT URINE AMPHETAMINE by Syva Co.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K833579 · Syva Co. · Toxicology device
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Jan 1984
Decision
106d
Days
Class 2
Risk

K833579 is an FDA 510(k) clearance for the MODIF. OF EMIT URINE AMPHETAMINE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1984 after a review of 106 days - within the typical 510(k) review window.

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 Syva Co. devices

Submission Details

510(k) Number K833579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 26, 1984
Days to Decision 106 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
19d slower than avg
Panel avg: 87d · This submission: 106d
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 K833579.
TDX AMPHETAMINE METHAMPHETAMINE
K853879 · Abbott Laboratories · Oct 1985
EMIT D.A.U. AMPHETAMINE ASSAY
K842674 · Syva Co. · Sep 1984
EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT
K843458 · Syva Co. · Sep 1984
EMIT-STM AMPHETAMINE ASSAY
K802623 · Syva Co. · Nov 1980
EMIT AMPHETAMINE CONFIRMATION REAGENT
K760936 · Syva Co. · Nov 1976
ASSAY, AMPHET. NDC#11711-0127-1 COULTER
K760196 · Coulter Electronics, Inc. · Aug 1976