510(k) · Cleared
ClearedVitalab Amylase Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Data, Inc. · JFJ Catalytic Methods, Amylase
Cleared on Mar 11, 2004 after a 9-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 11, 2004
- Review
- 9 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Roche α-Amylase EPS ver.2 Reagent, product no. 03183742 Named without a submission number |
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.
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 Vitalab ct-Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of cx-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040534 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040534: Vitalab Amylase Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040534
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026