Cleared Traditional

K970579 - ONE STEP MORPHINE CARD TEST

K970579 is an FDA 510(k) clearance for ONE STEP MORPHINE CARD TEST, manufactured by Teco Diagnostics. The device is a Class 2 Toxicology device with product code DNK cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K970579 · Teco Diagnostics · Toxicology device
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Jul 1997
Decision
139d
Days
Class 2
Risk

K970579 is an FDA 510(k) clearance for the ONE STEP MORPHINE CARD TEST. Classified as Thin Layer Chromatography, Morphine (product code DNK), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 139 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K970579

510(k) Number K970579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1997
Decision Date July 03, 1997
Days to Decision 139 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 87d · This submission: 139d
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.