Cleared Traditional

K002337 - BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST

K002337 is an FDA 510(k) clearance for BRANAN MEDICAL CORPORATION MONITECT BAR..., manufactured by Branan Medical Corporation. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K002337 · Branan Medical Corporation · Toxicology device
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Nov 2000
Decision
113d
Days
Class 2
Risk

K002337 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), 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 113 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 - K002337

510(k) Number K002337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2000
Decision Date November 22, 2000
Days to Decision 113 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
26d slower than avg
Panel avg: 87d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 92
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K002337.
VERDICT -II BAR/BZO
K010561 · Medtox Diagnostics, Inc. · Apr 2001
PROFILE-ER
K002331 · Medtox Diagnostics, Inc. · Jan 2001
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976 · OraSure Technologies, Inc. · Dec 2000
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
K000459 · Dade Behring, Inc. · Apr 2000
RAPIDONE- BARBITURATE TEST
K992451 · American Bio Medica Corp. · Apr 2000
BIONIKE AQ BARBITURATE TEST
K990280 · Bionike, Inc. · Jun 1999