Cleared Traditional

MDI QUIK TEST NARCOTICS DRUG SCREEN (K853140) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853140 · Medical Diagnostics, Ca. · Toxicology device
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Mar 1986
Decision
217d
Days
Class 2
Risk

K853140 is an FDA 510(k) clearance for the MDI QUIK TEST NARCOTICS DRUG SCREEN. Classified as Thin Layer Chromatography, Morphine (product code DNK), Class II - Special Controls.

Submitted by Medical Diagnostics, Ca. (Columbia, US). The FDA issued a Cleared decision on March 3, 1986 after a review of 217 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3640 - 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 Medical Diagnostics, Ca. devices

Submission Details

510(k) Number K853140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1985
Decision Date March 03, 1986
Days to Decision 217 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 87d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DNK Thin Layer Chromatography, Morphine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3640
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.