Cleared Traditional

K853140 - MDI QUIK TEST NARCOTICS DRUG SCREEN

K853140 is an FDA 510(k) clearance for MDI QUIK TEST NARCOTICS DRUG SCREEN, manufactured by Medical Diagnostics, Ca.. The device is a Class 2 Toxicology device with product code DNK cleared through the Traditional 510(k) pathway after a 217-day FDA review.

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

FDA 510(k) Submission Details - K853140

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.

DNK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DNK Thin Layer Chromatography, Morphine

Devices cleared under the same product code (DNK) and FDA review panel - the closest regulatory comparables to K853140.
EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine
K151557 · Nantong Egens Biotech Co., Ltd. · Jul 2015
CR3 Keyless Split Sample Cup Morphine - Methamphetamine
K150602 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2015
ONE STEP MORPHINE CARD TEST
K970579 · Teco Diagnostics · Jul 1997