Cleared Traditional

MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (K931148) - FDA 510(k) Clearance

Class I Chemistry device.

K931148 · Esa, Inc. · Chemistry device
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Jun 1993
Decision
96d
Days
Class 1
Risk

K931148 is an FDA 510(k) clearance for the MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM. Classified as Chromatographic/fluorometric Method, Catecholamines (product code CHQ), Class I - General Controls.

Submitted by Esa, Inc. (Bedford, US). The FDA issued a Cleared decision on June 9, 1993 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1165 - 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.

View all Esa, Inc. devices

Submission Details

510(k) Number K931148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1993
Decision Date June 09, 1993
Days to Decision 96 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 88d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHQ Chromatographic/fluorometric Method, Catecholamines
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1165
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.