Cleared Special

K022564 - INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST

K022564 is the FDA 510(k) clearance for INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST by Alfa Scientific Designs, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Special 510(k) pathway after a 28-day FDA review.

K022564 · Alfa Scientific Designs, Inc. · Toxicology device
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Aug 2002
Decision
28d
Days
Class 2
Risk

K022564 is an FDA 510(k) clearance for the INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on August 30, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K022564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2002
Decision Date August 30, 2002
Days to Decision 28 days
Submission Type Special
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
59d faster than avg
Panel avg: 87d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 125
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K014247 · Biosite Incorporated · Jun 2002
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K012745 · Biosite Incorporated · Jan 2002