Cleared Traditional

K883586 - TECHNICON RA-100 SYSTEM POTASSIUM (FDA 510(k) Clearance)

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

K883586 · Technicon Instruments Corp. · Chemistry device
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Nov 1988
Decision
98d
Days
Class 2
Risk

K883586 is an FDA 510(k) clearance for the TECHNICON RA-100 SYSTEM POTASSIUM. Classified as Tetraphenyl Borate, Colorimetry, Potassium (product code CEJ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 29, 1988 after a review of 98 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K883586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1988
Decision Date November 29, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEJ Tetraphenyl Borate, Colorimetry, 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.