# K051447: Sentinel Pancreatic Amylase

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Ch. Srl
- Decided: Jan 26, 2006 after 238 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895880 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895880: Pancreatic a-Amylase Eps, Boehringer Mannheim Corp. (1989) Summary page 2.

## Indications for use
The Sentinel Pancreatic Amylase is used for the quantitation of pancreatic amylase levels in human serum or plasma. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). For In Vitro use only.

Source page: https://510kreport.com/device/K051447
Methodology: https://510kreport.com/methodology