Cleared Traditional

SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (K103373) - FDA 510(k) Clearance

Class I Toxicology device.

K103373 · Beckman Coulter, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
82d
Days
Class 1
Risk

K103373 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 7, 2011 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3240 - the FDA toxicology device 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 K103373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2010
Decision Date February 07, 2011
Days to Decision 82 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 87d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIH Colorimetry, Cholinesterase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.