510(k) · Cleared
ClearedHitachi Clinical Analyzer S Test Reagent Cartridges for LD and Amy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Chemical Diagnostics, Inc. · JFJ Catalytic Methods, Amylase
Cleared on Aug 9, 2013 as substantially equivalent to K100853 (Roche Diagnostics Corp., 2010) after a 149-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 9, 2013
- Review
- 149 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953239 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- 2 generations backK060373 Cobas 6000 Series SystemRoche Diagnostics · 2006 · Recalled
- 1 generation backK100853 Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. · 2010 · Recalled
- This deviceK130685 Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyHitachi Chemical Diagnostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| −2 | K060373 | Cobas 6000 Series System | Roche Diagnostics | 2006 | 10 |
| −1 | K100853 | Cobas 8000 Modular Series Analyzer | Roche Diagnostics Corp. | 2010 | 11 |
| 0 (this device) | K130685 | Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and Amy | Hitachi Chemical Diagnostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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 |
|---|---|---|---|
| * | K100853 | Cobas 8000 Modular Series AnalyzerSummary page 1…Amylase (AMY) 807.92 (a)(3): Identification of the legally marketed predicate devices Cobas c systems LDH12 (Roche Diagnostics, Inc., Indianapolis, IN)- K1 00853 Cobas c systems AMYL2 (Roche Diagnostics, Inc., Indianapolis, IN)- K100853 807.92 (a)(4): Device Description The H… | 2010 |
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 8 other devices also cite its predicate K100853.
How does its category compare?
All JFJ devicesJFJ Catalytic Methods, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for the quantitative determination of LD in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of LD are used in the diagnosis and treatment of liver and cardiac diseases. The S TEST Reagent Cartridge…
Read the full statement (129 words)
The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for the quantitative determination of LD in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of LD are used in the diagnosis and treatment of liver and cardiac diseases.
The S TEST Reagent Cartridge Amylase (AMY) is intended for the quantitative determination of AMY in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Amylase (AMY) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of AMY are mainly used in the diagnosis and treatment of pancreatic diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130685: Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and Amy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130685
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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