Cleared Traditional

K843458 - EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT

K843458 is the FDA 510(k) clearance for EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT by Syva Co.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K843458 · Syva Co. · Toxicology device
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Sep 1984
Decision
15d
Days
Class 2
Risk

K843458 is an FDA 510(k) clearance for the EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT. 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 September 20, 1984 after a review of 15 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 K843458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date September 20, 1984
Days to Decision 15 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
72d faster than avg
Panel avg: 87d · This submission: 15d
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 K843458.
DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5
K871696 · Diagnostic Products Corp. · Jun 1987
TDX AMPHETAMINE METHAMPHETAMINE
K853879 · Abbott Laboratories · Oct 1985
EMIT D.A.U. AMPHETAMINE ASSAY
K842674 · Syva Co. · Sep 1984
MODIF. OF EMIT URINE AMPHETAMINE
K833579 · Syva Co. · Jan 1984
EMIT-STM AMPHETAMINE ASSAY
K802623 · Syva Co. · Nov 1980
EMIT AMPHETAMINE CONFIRMATION REAGENT
K760936 · Syva Co. · Nov 1976