Cleared Traditional

K831227 - COMPUR EASY TOUCH CHEMISTRY ANALYZER-

K831227 is the FDA 510(k) clearance for COMPUR EASY TOUCH CHEMISTRY ANALYZER- by Worthington Diagnostic Systems. It is a Class 1 Chemistry device (product code JJF) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831227 · Worthington Diagnostic Systems · Chemistry device
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Jun 1983
Decision
48d
Days
Class 1
Risk

K831227 is an FDA 510(k) clearance for the COMPUR EASY TOUCH CHEMISTRY ANALYZER-. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Worthington Diagnostic Systems (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Worthington Diagnostic Systems devices

Submission Details

510(k) Number K831227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1983
Decision Date June 02, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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.

Regulatory Peers - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 35
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K831227.
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