510(k) · Cleared
ClearedHitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Chemical Diagnostics, Inc. · CIC Cresolphthalein Complexone, Calcium
Cleared on May 2, 2013 as substantially equivalent to K100853 (Roche Diagnostics Corp., 2010) after a 34-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 2, 2013
- Review
- 34 days
- Class
- Class II
- Product code
- CIC
- 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 deviceK130870 Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA)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) | K130870 | Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA) | 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 CIC? 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? (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…(a)(3): Identification of the legally marketed predicate devices Cobas c systems Calcium (CA) (Roche Diagnostics, Inc., Indianapolis, IN)- K 100853 807.92 (a)(4): Device Description The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for us… | 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 CIC devicesCIC Cresolphthalein Complexone, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CIC
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CIC
Too few CIC 510(k)s in any year since 2007 to give a median.
Recalls per year · CIC
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIC
10in 2025
MAUDE reports naming product code CIC, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 5 |
| 2010 | 0 | — | 2 | 83 |
| 2011 | 0 | — | 0 | 29 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 30 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 42 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The S TEST Reagent Cartridge Calcium (CA) is intended for the quantitative determination of
calcium in serum, lithium heparinized plasma, and sodium citrate plasma using the HITACHI
Clinical Analyzer E40. The S TEST Reagent Cartridge Calcium is intended for use in clinical
laboratories or physician office laboratories. For in vitro diagnostic use only.
Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety
of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130870: Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130870
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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