Cleared Traditional

K002263 - BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST

K002263 is an FDA 510(k) clearance for BRANAN MEDICAL CORPORARTION MONITECT TH..., manufactured by Branan Medical Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K002263

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.

LDJ Device Classification - Class 2, Special Controls

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 125
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K002263.
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
PROFILE II ER
K010138 · Medtox Diagnostics, Inc. · Feb 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375 · OraSure Technologies, Inc. · Jan 2001
FIRST CHECK HOME DRUG TEST (THC)
K993663 · Worldwide Medical Corp. · Jun 2000
FIRST CHECK HOME DRUG TEST PANEL 3
K994138 · Worldwide Medical Corp. · Jun 2000
FIRST CHECK HOME DRUG TEST PANEL 2
K994139 · Worldwide Medical Corp. · Jun 2000