Cleared Traditional

K051447 - SENTINEL PANCREATIC AMYLASE

K051447 is the FDA 510(k) clearance for SENTINEL PANCREATIC AMYLASE by Sentinel Ch. Srl. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K051447 · Sentinel Ch. Srl · Chemistry device
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Jan 2006
Decision
238d
Days
Class 2
Risk

K051447 is an FDA 510(k) clearance for the SENTINEL PANCREATIC AMYLASE. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on January 26, 2006 after a review of 238 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sentinel Ch. Srl devices

Submission Details

510(k) Number K051447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date January 26, 2006
Days to Decision 238 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 88d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFJ Catalytic Methods, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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 - JFJ Catalytic Methods, Amylase

All 73
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K051447.
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
K091846 · Beckman Coulter, Inc. · Oct 2009
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823 · Medica Corp. · Nov 2008
AMYLASE EPS REAGENT
K070064 · Thermo Fisher Scientific · May 2007
AMYLASE LIQUID REAGENT, MODEL A532-200
K040920 · Teco Diagnostics · May 2004
VITALAB AMYLASE REAGENT
K040534 · Clinical Data, Inc. · Mar 2004
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · Beckman Coulter, Inc. · Jan 2002