Cleared Traditional

K854723 - SKD ELECTROCHEMICAL SYSTEM (ECS) (FDA 510(k) Clearance)

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

K854723 · Smithkline Diagnostics, Inc. · Chemistry device
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Mar 1986
Decision
103d
Days
Class 2
Risk

K854723 is an FDA 510(k) clearance for the SKD ELECTROCHEMICAL SYSTEM (ECS). Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 5, 1986 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K854723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1985
Decision Date March 05, 1986
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 88d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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.