Cleared Special

K051444 - SENTINEL CHOLINESTERASE LIQUID

K051444 is an FDA 510(k) clearance for SENTINEL CHOLINESTERASE LIQUID, manufactured by Sentinel Ch. Srl. The device is a Class 1 Toxicology device with product code DIH cleared through the Special 510(k) pathway after a 18-day FDA review.

K051444 · Sentinel Ch. Srl · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K051444

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 87d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

DIH Device Classification - Class 1, General Controls

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
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045 · Olympus America, Inc. · Feb 2003
WIENER LAB COLINESTERASA AA
K023992 · Wiener Laboratories Saic · Feb 2003
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · Bayer Diagnostics Corp. · Jan 2002
CARESIDE CHOLINESTERASE
K002792 · Careside, Inc. · Nov 2000
K051444 · SENTINEL CHOLINESTERASE LIQUID
Download PDF FDA Summary Sentinel Ch. Srl