Cleared Traditional

K002268 - BRANAN MEDICAL CORPORATION MONITECT MOR...

K002268 is the FDA 510(k) clearance for BRANAN MEDICAL CORPORATION MONITECT MOR... by Branan Medical Corporation. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K002268 · Branan Medical Corporation · Toxicology device
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Nov 2000
Decision
125d
Days
Class 2
Risk

K002268 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST. Classified as Enzyme Immunoassay, Opiates (product code DJG), 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 862.3650 - 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 K002268 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 DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 137
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K002268.
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353 · ACON Laboratories, Inc. · Jul 2001
DRIDAU OPIATE ASSAY
K011150 · Microgenics Corp. · Jun 2001
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209 · Dade Behring, Inc. · Dec 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
K001178 · Microgenics Corp. · Jun 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
K000464 · Dade Behring, Inc. · Apr 2000
AT HOME DRUG TEST, MODEL 9083
K994234 · Phamatech · Dec 1999