Cleared Traditional

K002264 - BRANAN MEDICAL CORPORATION MONITECT COC...

K002264 is the FDA 510(k) clearance for BRANAN MEDICAL CORPORATION MONITECT COC... by Branan Medical Corporation. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K002264 · Branan Medical Corporation · Toxicology device
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Nov 2000
Decision
125d
Days
Class 2
Risk

K002264 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Branan Medical Corporation (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 862.3250 - 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 Corporation devices

Submission Details

510(k) Number K002264 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 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 83
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K002264.
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · Teco Diagnostics · Jun 2001
AT WORK DRUG TEST, MODEL 9177T AWT
K010833 · Phamatech · Apr 2001
AT HOME DRUG TEST, MODEL 9073 T
K010650 · Phamatech · Mar 2001
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
K994403 · Alfa Scientific Designs, Inc. · Aug 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
K994398 · Alfa Scientific Designs, Inc. · Jul 2000
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000467 · Dade Behring, Inc. · Apr 2000