Cleared Traditional

K110251 - SYNCHRON MULTI CALIBRATOR

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

K110251 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K110251

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.

JIX Device Classification - Class 2, Special Controls

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 269
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K110251.
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
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