510(k) · Cleared
ClearedS Test Reagent Cartridge Alp (Alkaline Phosphatase)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Chemical Diagnostics, Inc. · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Mar 22, 2013 as substantially equivalent to K100853 (Roche Diagnostics Corp., 2010) after a 59-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Mar 22, 2013
- Review
- 59 days
- Class
- Class II
- Product code
- CJE
- 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 deviceK130141 S Test Reagent Cartridge Alp (Alkaline Phosphatase)Hitachi 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) | K130141 | S Test Reagent Cartridge Alp (Alkaline Phosphatase) | 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 CJE? 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 CJE device
- #1 K251074 Tru Liver Health Test Panelscore 10.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 3…PREDICATE PltfrmHitachi insruen Clinical Analyzer Roche cobasec systems - K1 00853 (originally cleared under K 111753) Alkaline P/wsphatase (ALP) K numbe… | 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 CJE devicesCJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CJE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJE
Too few CJE 510(k)s in any year since 2007 to give a median.
Recalls per year · CJE
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJE
10in 2025
MAUDE reports naming product code CJE, 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 | 1 | — | 8 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 2 | — | 1 | 24 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The S TEST Reagent Cartridge Alkaline Phosphatase (ALP) is intended for the quantitative measurement of alkaline phosphatase activity in serum, lithium heparinized plasma, or sodium citrate plasma using the HITACHI Clinical Analyzer. The S TEST Reagent Cartridge Alkaline Phosphatase (ALP) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130141: S Test Reagent Cartridge Alp (Alkaline Phosphatase).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130141
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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