510(k) · Cleared
ClearedSentinel Pancreatic Amylase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentinel Ch. Srl · JFJ Catalytic Methods, Amylase
Cleared on Jan 26, 2006 as substantially equivalent to K895880 (Boehringer Mannheim Corp., 1989) after a 238-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jan 26, 2006
- Review
- 238 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895880 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- This deviceK051447 Sentinel Pancreatic AmylaseSentinel Ch. Srl · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| 0 (this device) | K051447 | Sentinel Pancreatic Amylase | Sentinel Ch. Srl | 2006 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JFJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFJ device
- #1 K210633 Amylase2score 3.7 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K895880 | Pancreatic a-Amylase EpsSummary page 2…atic alpha- amylase in the examined sample. Substantial Equivalence: The Sentinel Pancreatic Amylase is substantially equivalent to the Roche Pancreatic Amylase assay (K895880) on the Roche analyzer. These assays yield similar Performance Characteristics. Similarities: Both assays are in vitro clin… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K895880.
How does its category compare?
All JFJ devicesJFJ Catalytic Methods, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JFJ
Too few JFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JFJ
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFJ
1in 2025
MAUDE reports naming product code JFJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051447: Sentinel Pancreatic Amylase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051447
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026