Cleared Traditional

K002263 - BRANAN MEDICAL CORPORARTION MONITECT TH...

K002263 is the FDA 510(k) clearance for BRANAN MEDICAL CORPORARTION MONITECT TH... by Branan Medical Corp.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K002263 · Branan Medical Corp. · Toxicology device
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Nov 2000
Decision
125d
Days
Class 2
Risk

K002263 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on November 27, 2000 after a review of 125 days - within the typical 510(k) review window.

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 Branan Medical Corp. devices

Submission Details

510(k) Number K002263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2000
Decision Date November 27, 2000
Days to Decision 125 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 87d · This submission: 125d
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 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K002263.
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
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
K994410 · Alfa Scientific Designs, Inc. · Jun 2000
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