Cleared Special

SENTINEL CHOLINESTERASE LIQUID (K051444) - FDA 510(k) Clearance

Class I Toxicology device.

K051444 · Sentinel Ch. Srl · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
18d
Days
Class 1
Risk

K051444 is an FDA 510(k) clearance for the SENTINEL CHOLINESTERASE LIQUID. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on June 20, 2005 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sentinel Ch. Srl devices

Submission Details

510(k) Number K051444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date June 20, 2005
Days to Decision 18 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 87d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - DIH Colorimetry, Cholinesterase

All 25
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K051444.
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
K103373 · Beckman Coulter, Inc. · Feb 2011
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · Roche Diagnostics Corp. · Jul 2006
IL TEST CHOLINESTERASE
K943367 · Instrumentation Laboratory CO · Feb 1996
KODAK EKTACHEM DT SLIDES (CHE)
K913198 · Eastman Kodak Company · Aug 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · Eastman Kodak Company · Jul 1991
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272 · Sigma Chemical Co. · Mar 1989