Cleared Traditional

K994410 - INSTANT-VIEW MARIJUANA (THC) URINE DIP ...

K994410 is the FDA 510(k) clearance for INSTANT-VIEW MARIJUANA (THC) URINE DIP ... by Alfa Scientific Designs, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K994410 · Alfa Scientific Designs, Inc. · Toxicology device
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Jun 2000
Decision
176d
Days
Class 2
Risk

K994410 is an FDA 510(k) clearance for the INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (San Diego, US). The FDA issued a Cleared decision on June 21, 2000 after a review of 176 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 K994410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date June 21, 2000
Days to Decision 176 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
89d slower than avg
Panel avg: 87d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K994410.
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · Princeton BioMeditech Corp. · May 2002
CANNABINOIDS
K013247 · Abbott Laboratories · Mar 2002
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164 · Roche Diagnostics Corp. · Apr 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461 · Dade Behring, Inc. · Apr 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131 · Phamatech · Feb 2000