510(k) · Cleared
ClearedAtellica CH Amylase_2 (AMY_2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JFJ Catalytic Methods, Amylase
Cleared on Jul 30, 2019 as substantially equivalent to K903309 (Roche Diagnostic Systems, Inc., 1990) after a 60-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jul 30, 2019
- Review
- 60 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903309 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK903309 Roche Cobas Ready Amylase ReagentRoche Diagnostic Systems, Inc. · 1990
- This deviceK191454 Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903309 | Roche Cobas Ready Amylase Reagent | Roche Diagnostic Systems, Inc. | 1990 | — |
| 0 (this device) | K191454 | Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K903309 | Roche Cobas Ready Amylase ReagentSummary page 5…I Product Code: JFJ Panel: Clinical Chemistry Predicate Device: Roche Cobas Amylase Reagent (k903309) DEVICE DESCRIPTION ATELLICA CH AMYLASE_2 (AMY-2) The Atellica® CH Amylase_2 (AMY_2) assay is based on the procedure of Jensen… | 1990 |
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 K903309.
How does its category compare?
All JFJ devicesJFJ Catalytic Methods, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Atellica® CH Amylase_2 (AMY_2) assay is for in vitro diagnostic use in the quantitative determination of amylase activity in human serum, plasma (lithium heparin), and urine using the Atellica® CH Analyzer. Such measurements are used primarily in the diagnosis and monitoring of acute pancreatitis (inflammation of the pancreas).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191454: Atellica CH Amylase_2 (AMY_2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191454
Report an extraction error
Are you the manufacturer?
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