Cleared Abbreviated

K022501 - INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST

K022501 is an FDA 510(k) clearance for INSTANT-VIEW MDMA (ECSTASY, manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Toxicology device with product code DJC cleared through the Abbreviated 510(k) pathway after a 107-day FDA review.

K022501 · Alfa Scientific Designs, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
107d
Days
Class 2
Risk

K022501 is an FDA 510(k) clearance for the INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on November 13, 2002 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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.

FDA 510(k) Submission Details - K022501

510(k) Number K022501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date November 13, 2002
Days to Decision 107 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 87d · This submission: 107d
Pathway characteristics
Standards-based clearance path.

DJC Device Classification - Class 2, Special Controls

Product Code DJC Thin Layer Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - DJC Thin Layer Chromatography, Methamphetamine

All 30
Devices cleared under the same product code (DJC) and FDA review panel - the closest regulatory comparables to K022501.
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST
K053033 · Acro Biotech, LLC · Jun 2006
AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
K031497 · Amedica Biotech, Inc. · Oct 2003
STARTOX DRUG OF ABUSE SCREENING TEST (4)
K022388 · Starplex Scientific, Inc. · Feb 2003
VERDICT-II
K022141 · Medtox Diagnostics, Inc. · Jul 2002
PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
K011185 · Psychemedics Corp. · Jan 2002
RAPIDONE-ECSTASY TEST
K013180 · American Bio Medica Corp. · Nov 2001
K022501 · INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
Download PDF FDA Summary Alfa Scientific Desig…