Cleared Traditional

K862561 - TECHNICON RA-XT SYSTEM WITH ANALYTES (FDA 510(k) Clearance)

Class I Chemistry device.

K862561 · Technicon Instruments Corp. · Chemistry device
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Oct 1986
Decision
109d
Days
Class 1
Risk

K862561 is an FDA 510(k) clearance for the TECHNICON RA-XT SYSTEM WITH ANALYTES. Classified as Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (product code JJC), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 20, 1986 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2150 - 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K862561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date October 20, 1986
Days to Decision 109 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 88d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2150
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.