Cleared Traditional

BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST (K002337) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 99
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K002337.
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