Cleared Traditional

K002342 - BRANAN MEDICAL CORPORATION MONITECT BZO...

K002342 is the FDA 510(k) clearance for BRANAN MEDICAL CORPORATION MONITECT BZO... by Branan Medical Corporation. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K002342 · Branan Medical Corporation · Toxicology device
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Nov 2000
Decision
118d
Days
Class 2
Risk

K002342 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), 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 118 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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 K002342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2000
Decision Date November 27, 2000
Days to Decision 118 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
31d slower than avg
Panel avg: 87d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 70
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K002342.
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · ACON Laboratories, Inc. · Sep 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
K003879 · Alfa Scientific Designs, Inc. · May 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
K003881 · Alfa Scientific Designs, Inc. · May 2001
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · Dade Behring, Inc. · Apr 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985 · Syva Co. · Jan 2000
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · Roche Diagnostics Corp. · Jun 1999