Cleared Traditional

K042291 - UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS

K042291 is the FDA 510(k) clearance for UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K042291 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
80d
Days
Class 2
Risk

K042291 is an FDA 510(k) clearance for the UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 12, 2004 after a review of 80 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K042291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date November 12, 2004
Days to Decision 80 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
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, 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.

Regulatory Peers - CEM Electrode, Ion Specific, Potassium

All 52
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