510(k) · Cleared
Clearedalpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosystems S.A. · JFJ Catalytic Methods, Amylase
Cleared on May 2, 2019 after a 234-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 2, 2019
- Review
- 234 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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. 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?
alpha-AMYLASE DIRECT: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. alpha-AMYLASE EPS: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as…
Read the full statement (271 words)
alpha-AMYLASE DIRECT: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
alpha-AMYLASE EPS: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
alpha-AMYLASE PANCREATIC: Reagent for the measurement of pancreatic a-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
BILIRUBIN DIRECT: Reagent for the measurement of direct bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
BILIRUBIN TOTAL: Reagent for the measurement of total bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182474: alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182474
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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