Cleared Abbreviated

K141388 - SYSTEM CALIBRATER (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K141388 · Beckman Coulter Ireland, Inc. · Chemistry device
Jul 2014
Decision
45d
Days
Class 2
Risk

K141388 is an FDA 510(k) clearance for the SYSTEM CALIBRATER. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Beckman Coulter Ireland, Inc. (Brea, US). The FDA issued a Cleared decision on July 11, 2014 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K141388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2014
Decision Date July 11, 2014
Days to Decision 45 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
189d faster than avg
Panel avg: 234d · This submission: 45d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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.