Cleared Traditional

K051447 - SENTINEL PANCREATIC AMYLASE

K051447 is an FDA 510(k) clearance for SENTINEL PANCREATIC AMYLASE, manufactured by Sentinel Ch. Srl. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K051447

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
Combination Product No
PCCP Authorized No
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.

JFJ Device Classification - Class 2, Special Controls

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 93
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K051447.
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823 · Medica Corp. · Nov 2008
AMYLASE EPS REAGENT
K070064 · Thermo Fisher Scientific · May 2007
ABX PENTRA AMYLASE CP
K062180 · Horiba Abx · Oct 2006
AMYLASE LIQUID REAGENT, MODEL A532-200
K040920 · Teco Diagnostics · May 2004
VITALAB AMYLASE REAGENT
K040534 · Clinical Data, Inc. · Mar 2004
WIENER LAB AMILASA 405 AA LIQUIDA
K023549 · Wiener Laboratories Saic · Dec 2002