510(k) · Cleared
ClearedSynchron Systems Pancreatic Amylase (Pam) Reagent
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 Jan 15, 2002 as substantially equivalent to K934293 (Beckman-Diagnostic Systems Group, 1994) after a 43-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 15, 2002
- Review
- 43 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934293 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK934293 Beckman Pancreatic Amylase (Pamy) ReagentBeckman-Diagnostic Systems Group · 1994
- This deviceK013978 Synchron Systems Pancreatic Amylase (Pam) ReagentBeckman Coulter, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934293 | Beckman Pancreatic Amylase (Pamy) Reagent | Beckman-Diagnostic Systems Group | 1994 | — |
| 0 (this device) | K013978 | Synchron Systems Pancreatic Amylase (Pam) Reagent | Beckman Coulter, Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K934293 | Beckman Pancreatic Amylase (Pamy) ReagentSummary page 1…iter Predicate Manufacturer Docket Number SYNCHRON® Systems SYNCHRON CX® Systems | Beckman Coulter Pancreatic Amylase Pancreatic Amylase (PAM) Reagent (PAMY) Reagent K934293 Description: Beckman Coulter's Pancreatic Amylase (PAM) Reagent is a liquid stable, ready-to-use reagent designed for optimal p… | 1994 |
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.
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?
Pancreatic Amylase (PAM) Reagent is intended for the quantitative determination of pancreas-specific amylase activity in human serum, plasma, or urine on Beckman Coulter's SYNCHRON Systems by an immuno-inhibition method. Measurement of pancreatic amylase is useful in the diagnosis and treatment of pancreatitis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013978: Synchron Systems Pancreatic Amylase (Pam) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013978
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026