Cleared Traditional

K002342 - BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST

K002342 is an FDA 510(k) clearance for BRANAN MEDICAL CORPORATION MONITECT BZO..., manufactured by Branan Medical Corporation. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K002342

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.

JXM Device Classification - Class 2, Special Controls

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 86
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K002342.
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
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
K011306 · Syva Co., Dade Behring, Inc. · May 2001
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · Dade Behring, Inc. · Apr 2000
RAPIDONE- BENZODIAZEPINE TEST
K992720 · American Bio Medica Corp. · Apr 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985 · Syva Co. · Jan 2000