Cleared Traditional

K792282 - DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG

K792282 is the FDA 510(k) clearance for DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG by California Medical Developments, Inc.. It is a Class 2 Toxicology device (product code DKE) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K792282 · California Medical Developments, Inc. · Toxicology device
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Feb 1980
Decision
108d
Days
Class 2
Risk

K792282 is an FDA 510(k) clearance for the DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG. Classified as Reagents, Test, Tetrahydrocannabinol (product code DKE), Class II - Special Controls.

Submitted by California Medical Developments, Inc. (Walker, US). The FDA issued a Cleared decision on February 29, 1980 after a review of 108 days - within the typical 510(k) review window.

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 California Medical Developments, Inc. devices

Submission Details

510(k) Number K792282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1979
Decision Date February 29, 1980
Days to Decision 108 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 87d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKE Reagents, Test, Tetrahydrocannabinol
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 - DKE Reagents, Test, Tetrahydrocannabinol

All 7
Devices cleared under the same product code (DKE) and FDA review panel - the closest regulatory comparables to K792282.
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
K983147 · Princeton BioMeditech Corp. · Sep 1998
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182 · Marion Laboratories, Inc. · Jul 1988
TOXI-LAB CANNABINOID THC SCREEN
K831456 · Marion Laboratories, Inc. · Jun 1983