510(k) · Cleared
ClearedAmylase Eps-G7 (Liquid) Reagent Set, (Hitachi Analyzers)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pointe Scientific, Inc., · CIJ Saccharogenic, Amylase
Cleared on Dec 23, 2002 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 23, 2002
- Review
- 75 days
- Class
- Class II
- Product code
- CIJ
- 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 CIJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 CIJ devicesCIJ Saccharogenic, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIJ
FDA has decided no CIJ device since 2007.
Median 510(k) review, days · CIJ
Too few CIJ 510(k)s in any year since 2007 to give a median.
Recalls per year · CIJ
No recall names CIJ since 2007.
Adverse event reports per year · CIJ
1in 2015
MAUDE reports naming product code CIJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of amylase in human serum. It is intended for in vitro diagnostic use only. The determination of amylase in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023396: Amylase Eps-G7 (Liquid) Reagent Set, (Hitachi Analyzers).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023396
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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