Cleared Traditional

K834458 - EMIT D.A.U. URINE CANNABINOID ASSAY

K834458 is the FDA 510(k) clearance for EMIT D.A.U. URINE CANNABINOID ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K834458 · Syva Co. · Toxicology device
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Jun 1984
Decision
185d
Days
Class 2
Risk

K834458 is an FDA 510(k) clearance for the EMIT D.A.U. URINE CANNABINOID ASSAY. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on June 21, 1984 after a review of 185 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 K834458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date June 21, 1984
Days to Decision 185 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
98d slower than avg
Panel avg: 87d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K834458.
EMIT D.A.U. CANNABINOID 20NG ASSAY
K860500 · Syva Co. · Apr 1986
EMIT 700 CANNABINOID 20 ASSAY
K851373 · Syva Co. · May 1985
EMIT 700 CANNABINOID ASSAY
K843421 · Syva Co. · Sep 1984
EMIT ST URINE CANNABINOID ASSAY
K841238 · Syva Co. · Jun 1984
MODIF. OF EMIT URINE CANNABINOID
K833580 · Syva Co. · Jan 1984
EMIT-ST CANNABINOID ASSAY
K812195 · Syva Co. · Aug 1981