Cleared Traditional

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

K834458 is an FDA 510(k) clearance for EMIT D.A.U. URINE CANNABINOID ASSAY, manufactured by Syva Co.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K834458

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.

LDJ Device Classification - Class 2, Special Controls

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 124
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