Cleared Traditional

K994405 - INSTANT-VIEW MARIJUANA URINE CASSETTE TEST

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

K994405 · Alfa Scientific Designs, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K994405

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.

DKE Device Classification - Class 2, Special Controls

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

All 8
Devices cleared under the same product code (DKE) and FDA review panel - the closest regulatory comparables to K994405.
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
K003687 · Medtox Diagnostics, Inc. · Dec 2000
STATUS STIK, ACCUSIGN STIK
K992068 · Princeton BioMeditech Corp. · Jul 1999
STATUS CUP ACCUSIGN CUP
K991751 · Princeton BioMeditech Corp. · Jun 1999
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
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
K983147 · Princeton BioMeditech Corp. · Sep 1998
PROFILE-II MODEL 600582
K982211 · Medtox Diagnostics, Inc. · Jul 1998