510(k) · Cleared
ClearedEasyra Amylase, Bun, Glu-H, Trig, Uric Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medica Corp. · JFJ Catalytic Methods, Amylase
Cleared on Nov 17, 2008 after a 238-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 17, 2008
- Review
- 238 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. 2008, 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 EasyRA amylase Reagent (AMY) is for the measurement of a-Amylase in serum using the "EasyRA chemistry analyzer". Amylase measurements are used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) and other pancreatic disorders. For in vitro diagnostic use only. The EasyRA Blood Urea Nitrogen (BUN) Reagent is for the measurement of urea in serum using the "EasyRA chemistry analyzer". Urea measurements in serum are used for…
Read the full statement (242 words)
The EasyRA amylase Reagent (AMY) is for the measurement of a-Amylase in serum using the "EasyRA chemistry analyzer". Amylase measurements are used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) and other pancreatic disorders. For in vitro diagnostic use only.
The EasyRA Blood Urea Nitrogen (BUN) Reagent is for the measurement of urea in serum using the "EasyRA chemistry analyzer". Urea measurements in serum are used for the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use only.
The EasyRA Glucose hexokinase (GLU-H) Reagent is for the measurement of glucose in serum using the "EasyRA chemistry analyzer".. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . For in vitro diagnostic use only.
The EasyRA Triglyceride (TRIG) Reagent is for the measurement of triglycerides in serum using the "EasyRA chemistry analyzer". Triglyceride measurements are used in the diagnosis and treatment of diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders. For in vitro diagnostic use only.
The EasyRA Uric Acid (URIC) Reagent is for the measurement of uric acid in serum using the "EasyRA chemistry analyzer". Uric Acid measurements are used in the diagnosis and treatment of renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. For in vitro diagnostic use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080823: Easyra Amylase, Bun, Glu-H, Trig, Uric Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080823
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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