Cleared Traditional

K994395 - INSTANT-VIEW AMPHETAMINE URINE CASSETTE...

K994395 is the FDA 510(k) clearance for INSTANT-VIEW AMPHETAMINE URINE CASSETTE... by Alfa Scientific Designs, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K994395 · Alfa Scientific Designs, Inc. · Toxicology device
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Aug 2000
Decision
223d
Days
Class 2
Risk

K994395 is an FDA 510(k) clearance for the INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (San Diego, US). The FDA issued a Cleared decision on August 7, 2000 after a review of 223 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K994395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date August 07, 2000
Days to Decision 223 days
Submission Type Traditional
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
136d slower than avg
Panel avg: 87d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K994395.
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K994399 · Alfa Scientific Designs, Inc. · Aug 2000
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K001421 · Roche Diagnostics Corp. · Jul 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417 · Roche Diagnostics Corp. · Jun 2000