Cleared Abbreviated

K022693 - INSTANT-VIEW TCA URINE TEST (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K022693 · Alfa Scientific Designs, Inc. · Toxicology device
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Dec 2002
Decision
118d
Days
Class 2
Risk

K022693 is an FDA 510(k) clearance for the INSTANT-VIEW TCA URINE TEST. Classified as Thin Layer Chromatography, Tricyclic Antidepressant Drugs (product code MLK), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on December 9, 2002 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3910 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K022693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2002
Decision Date December 09, 2002
Days to Decision 118 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 87d · This submission: 118d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3910
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.