Cleared Traditional

K792282 - DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG

K792282 is an FDA 510(k) clearance for DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG, manufactured by California Medical Developments, Inc.. The device is a Class 2 Toxicology device with 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.

FDA 510(k) Submission Details - K792282

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
Combination Product No
PCCP Authorized No
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.

DKE Device Classification - Class 2, Special Controls

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.

K792282 · DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG
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