510(k) · Cleared
ClearedAmylase Eps Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific · JFJ Catalytic Methods, Amylase
Cleared on May 22, 2007 after a 137-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 22, 2007
- Review
- 137 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK070064 Amylase Eps ReagentThermo Fisher Scientific · 2007
- Descendant · cites it directly · 0 of its ownK091846 Synchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607Beckman Coulter, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091846Synchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607Beckman Coulter, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070064 | Amylase Eps Reagent | Thermo Fisher Scientific | 2007 | — |
| +1 | K091846 | Synchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607 | Beckman Coulter, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091846 | Synchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607 | 2009 | 0 |
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?
- Of its descendants, K091846 (Beckman Coulter, Inc., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JFJ devicesJFJ Catalytic Methods, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Amylase EPS Reagent is used for the quantitative determination of oa-Amylase (1,4-a-D-glucan glucanohydrolase EC3.2.1.1) in human serum, plasma or urine on Beckman Coulter SYNCHRON CX ®/LX ® Systems.
oc-Amylase is most frequently measured in the diagnosis of acute pancreatitis, when serum levels may be grossly elevated.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K070064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070064: Amylase Eps Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070064
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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