510(k) · Cleared
ClearedHitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge Ast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Chemical Diagnostics, Inc. · CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Cleared on Jun 7, 2013 as substantially equivalent to K974003 (Diagnostic Chemicals, Ltd., 1997) and 1 other predicate after a 435-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 7, 2013
- Review
- 435 days
- Class
- Class I
- Product code
- CKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953239 (1995). 5 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 deviceK120945 Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi…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) | K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical… | Hitachi Chemical Diagnostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 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 CKA? 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? (2)
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 |
|---|---|---|---|
| * | K974003 | Alanine Aminotransferase-SL Assay Catalogue Number 318-10, 318-30Summary page 1…tion by 21 CFR + §862.9, product code CKA AST-21 CRF §862.1100, Class II, product code CIT 807.92 (a)(3): Identification of the legally marketed predicate devices ALT: K974003- ALT SL Assay (Sekisui Diagnostics, Ltd, PEI, Canada) AST: K100853- ASTL assay (cobas, Roche Diagnostics, Indianapolis, IN) 807.… | 1997 |
| * | K100853 | Cobas 8000 Modular Series AnalyzerSummary page 1…ss II, product code CIT 807.92 (a)(3): Identification of the legally marketed predicate devices ALT: K974003- ALT SL Assay (Sekisui Diagnostics, Ltd, PEI, Canada) AST: K100853- ASTL assay (cobas, Roche Diagnostics, Indianapolis, IN) 807.92 (a)(4): Device Description The Hitachi Clinical Analyzer is an… | 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 5 ancestors have a recall of any class.
How does its category compare?
All CKA devicesCKA Nadh Oxidation/Nad Reduction, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CKA
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CKA
Too few CKA 510(k)s in any year since 2007 to give a median.
Recalls per year · CKA
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CKA
8in 2025
MAUDE reports naming product code CKA, 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 | — | 8 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 8 |
| 2011 | 0 | — | 0 | 39 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The S TEST Reagent Cartridge Alanine Amino Transferase (ALT) is intended for the quantitative measurement of the activity of the enzyme alanine amino transferase (ALT) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ALT measurements are used in the diagnosis and…
Read the full statement (168 words)
The S TEST Reagent Cartridge Alanine Amino Transferase (ALT) is intended for the quantitative measurement of the activity of the enzyme alanine amino transferase (ALT) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
The S TEST Reagent Cartridge Aspartate Amino Transferase (AST) is intended for the quantitative measurement of the activity of the enzyme aspartate amino transferase (AST) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120945: Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge Ast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120945
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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