Cleared Traditional

K994405 - INSTANT-VIEW MARIJUANA URINE CASSETTE TEST

K994405 is the FDA 510(k) clearance for INSTANT-VIEW MARIJUANA URINE CASSETTE TEST by Alfa Scientific Designs, Inc.. It is a Class 2 Toxicology device (product code DKE) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K994405 · Alfa Scientific Designs, Inc. · Toxicology device
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Jun 2000
Decision
157d
Days
Class 2
Risk

K994405 is an FDA 510(k) clearance for the INSTANT-VIEW MARIJUANA URINE CASSETTE TEST. Classified as Reagents, Test, Tetrahydrocannabinol (product code DKE), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (San Diego, US). The FDA issued a Cleared decision on June 2, 2000 after a review of 157 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 K994405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date June 02, 2000
Days to Decision 157 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
70d slower than avg
Panel avg: 87d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKE Reagents, Test, Tetrahydrocannabinol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - DKE Reagents, Test, Tetrahydrocannabinol

Devices cleared under the same product code (DKE) and FDA review panel - the closest regulatory comparables to K994405.
STATUS STIK, ACCUSIGN STIK
K992068 · Princeton BioMeditech Corp. · Jul 1999
STATUS CUP ACCUSIGN CUP
K991751 · Princeton BioMeditech Corp. · Jun 1999
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K991078 · Princeton BioMeditech Corp. · Apr 1999
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
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TOXI-LAB CANNABINOID THC SCREEN
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