Cleared Traditional

K110251 - SYNCHRON MULTI CALIBRATOR

K110251 is the FDA 510(k) clearance for SYNCHRON MULTI CALIBRATOR by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K110251 · Beckman Coulter, Inc. · Chemistry device
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May 2011
Decision
117d
Days
Class 2
Risk

K110251 is an FDA 510(k) clearance for the SYNCHRON MULTI CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 25, 2011 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K110251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2011
Decision Date May 25, 2011
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 170
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K110251.
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