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Sentinel Pancreatic Amylase

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051447

by Sentinel Ch. Srl

Identifiers

510(k) Number
K051447 FDA 510(k)
FDA Product Code
JFJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1070 FDA 510(k)
Regulation Number
862.1070 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sentinel Pancreatic Amylase is a Catalytic Methods, Amylase device, classified under FDA regulation 862.1070. It is designed for the quantitative measurement of pancreatic amylase levels in human serum or plasma, aiding in the diagnosis and monitoring of conditions such as pancreatitis.

This in vitro diagnostic device is intended for single-use in clinical chemistry settings. It has received FDA 510(k) clearance under the Traditional pathway, with a decision date of January 26, 2006. The product code assigned is JFJ, and it falls under Class II regulatory classification. No additional sterility or MRI safety information is specified in the available data.

Frequently asked questions

What is the Sentinel Pancreatic Amylase used for?

The Sentinel Pancreatic Amylase is designed for the quantitative measurement of pancreatic amylase levels in human serum or plasma. This helps clinicians diagnose and monitor conditions such as pancreatitis by providing precise amylase concentration data, supporting timely and accurate patient management.

Is the Sentinel Pancreatic Amylase intended for single-use or reuse?

This device is explicitly intended for single-use in clinical chemistry settings. Single-use ensures patient safety by eliminating cross-contamination risks and maintains accuracy, as reuse could compromise sterility and test reliability.

What regulatory pathway was used for FDA clearance of this device?

The Sentinel Pancreatic Amylase received FDA 510(k) clearance under the Traditional pathway, demonstrating substantial equivalence to a predicate device. This pathway involves a detailed review by the FDA to confirm the device’s safety and effectiveness compared to existing, legally marketed alternatives.

Does the Sentinel Pancreatic Amylase require special storage conditions?

The provided data does not specify special storage conditions, but standard laboratory practices for in vitro diagnostic devices should be followed. This typically includes protecting the device from extreme temperatures, humidity, and light, as well as ensuring it remains in its original packaging until use.

What clinical specialty is this device primarily associated with?

The Sentinel Pancreatic Amylase falls under the clinical specialty of Clinical Chemistry. This classification reflects its role in analyzing biochemical components of blood or other bodily fluids, specifically focusing on enzymes like amylase to aid in diagnostic evaluations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SENTINEL PANCREATIC AMYLASE (K051447) — FDA 510(k) | Innolitics, SENTINEL PANCREATIC AMYLASE 510 (k) K051447 - FDA.report, Sentinel Ch. Srl FDA 510 (k) Products (2005-2007)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sentinel Ch. Srl

Sources (1)

  • FDA 510(k) K051447 24 fields · synced Oct 1, 2026