Cleared Traditional

K002266 - BRANAN MEDICAL CORPORATION MONITECT AMP...

K002266 is the FDA 510(k) clearance for BRANAN MEDICAL CORPORATION MONITECT AMP... by Branan Medical Corporation. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K002266 · Branan Medical Corporation · Toxicology device
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Nov 2000
Decision
120d
Days
Class 2
Risk

K002266 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Branan Medical Corporation (Irvine, US). The FDA issued a Cleared decision on November 22, 2000 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 K002266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2000
Decision Date November 22, 2000
Days to Decision 120 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
33d slower than avg
Panel avg: 87d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K002266.
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
K011673 · ACON Laboratories, Inc. · Jul 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645 · Phamatech · Mar 2001
COBAS INTEGRA AMPHETAMINES
K003865 · Roche Diagnostics Corp. · Feb 2001
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
K994395 · Alfa Scientific Designs, Inc. · Aug 2000
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
K994399 · Alfa Scientific Designs, Inc. · Aug 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421 · Roche Diagnostics Corp. · Jul 2000