Cleared Traditional

BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 (K010734) - FDA 510(k) Clearance

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

K010734 · Branan Medical Corp. · Chemistry device
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Jul 2001
Decision
140d
Days
Class 2
Risk

K010734 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21. Classified as Thin Layer Chromatography, Tricyclic Antidepressant Drugs (product code MLK), Class II - Special Controls.

Submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on July 30, 2001 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3910 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K010734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2001
Decision Date July 30, 2001
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 88d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3910
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 Chemistry devices follow this clearance model.