Cleared Traditional

K834457 - EMIT D.A.U. URINE CANNABINOID CALIBRA

K834457 is the FDA 510(k) clearance for EMIT D.A.U. URINE CANNABINOID CALIBRA by Syva Co.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K834457 · Syva Co. · Toxicology device
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Jun 1984
Decision
186d
Days
Class 2
Risk

K834457 is an FDA 510(k) clearance for the EMIT D.A.U. URINE CANNABINOID CALIBRA. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 186 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 K834457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date June 22, 1984
Days to Decision 186 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
99d slower than avg
Panel avg: 87d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K834457.
DU PONT GENTAMICIN ASSAY CALIBRATOR
K850059 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985
EMIT 700 CANNABINOID CALIBRATOR
K843420 · Syva Co. · Sep 1984
AMIKACIN CALIBRATOR ACA
K843210 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1984
DUPONT THEOPHYLLINE DIT CALIBRATOR
K841655 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
ACA DIGOXIN CALLIBRATOR
K841108 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1984
QUINIDINE CALIBRATOR
K840597 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1984