510(k) · Cleared
ClearedSynchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JFJ Catalytic Methods, Amylase
Cleared on Oct 16, 2009 as substantially equivalent to K070064 (Thermo Fisher Scientific, 2007) after a 116-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Oct 16, 2009
- Review
- 116 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070064 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK070064 Amylase Eps ReagentThermo Fisher Scientific · 2007
- This deviceK091846 Synchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607Beckman Coulter, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070064 | Amylase Eps Reagent | Thermo Fisher Scientific | 2007 | — |
| 0 (this device) | K091846 | Synchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607 | Beckman Coulter, Inc. | 2009 | — |
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 |
|---|---|---|---|
| * | K070064 | Amylase Eps ReagentSummary page 1…_ _ _ _ _ _ I _ _ _ _ _ I ~~Num ber SYNCHRON Systems G7 AyaeESRgnt Thermo Fisher K070064 Amylase (AMY7) Reagent myaeESRgnt Scientific, Inc. 5.0 Description: AMY7… | 2007 |
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.
How does its category compare?
All JFJ devicesJFJ Catalytic Methods, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
AMY7 reagent, in conjunction with SYNCHRON® System(s) and UniCel® DxC System(s), is intended for the quantitative determination of total Amylase activity in human serum, plasma or urine.
Amylase measurements are used primarily in the diagnosis and treatment of pancreatitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091846 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091846: Synchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091846
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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