Cleared Abbreviated

K051452 - SENTINEL CLIN CHEM CAL

K051452 is the FDA 510(k) clearance for SENTINEL CLIN CHEM CAL by Sentinel Ch. Srl. It is a Class 2 Chemistry device (product code JIX) cleared through the Abbreviated 510(k) pathway after a 145-day FDA review.

K051452 · Sentinel Ch. Srl · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
145d
Days
Class 2
Risk

K051452 is an FDA 510(k) clearance for the SENTINEL CLIN CHEM CAL. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on October 25, 2005 after a review of 145 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sentinel Ch. Srl devices

Submission Details

510(k) Number K051452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date October 25, 2005
Days to Decision 145 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 88d · This submission: 145d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 202
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K051452.
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
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K060940 · Ortho-Clinical Diagnostics, Inc. · Apr 2006
RANDOX CALIBRATION SERUM
K053153 · Randox Laboratories, Ltd. · Jan 2006
LIPOPROTEIN FOR MULTIPLE ANALYTES
K051619 · Bayer Healthcare, LLC · Aug 2005
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
K043460 · Olympus America, Inc. · Jan 2005
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
K050026 · Roche Diagnostics · Jan 2005