510(k) · Cleared
ClearedHitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Chemical Diagnostics, Inc. · DCN System, Test, C-Reactive Protein
Cleared on Aug 17, 2012 as substantially equivalent to K073277 (Roche Diagnostics Corp., 2008) and 2 other predicates after a 238-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Aug 17, 2012
- Review
- 238 days
- Class
- Class II
- Product code
- DCN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K895880 (1989). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 2 generations backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- 1 generation backK073277 Roche-Creactive Protein (Latex)Roche Diagnostics Corp. · 2008
- This deviceK113809 Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein…Hitachi Chemical Diagnostics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −2 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| −1 | K073277 | Roche-Creactive Protein (Latex) | Roche Diagnostics Corp. | 2008 | — |
| 0 (this device) | K113809 | Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP) | Hitachi Chemical Diagnostics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 DCN? 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 DCN device
- #1 K232624 CardioPhase® hsCRPscore 6.7 · 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? (3)
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 |
|---|---|---|---|
| * | K073277 | Roche-Creactive Protein (Latex)Summary page 1…ystem (CRP) 807.92 (a)(3): Identification of the legally marketed predicate devices Reagent Test: Roche C-Reactive Protein Latex (CRPLX)- k073277 Instrument Platform: Roche Cobas 8000 Modular Series Analyzer - k100853 Alfa Wasser… | 2008 |
| * | K100853 | Cobas 8000 Modular Series AnalyzerSummary page 1…agent Test: Roche C-Reactive Protein Latex (CRPLX)- k073277 Instrument Platform: Roche Cobas 8000 Modular Series Analyzer - k100853 Alfa Wasserman Diagnostic Technologies S40 Clinical Analyzer - k091413 807.92 (a)(4): Device Description The Hit… | 2010 |
| * | K091413 | S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015…Summary page 1…Instrument Platform: Roche Cobas 8000 Modular Series Analyzer - k100853 Alfa Wasserman Diagnostic Technologies S40 Clinical Analyzer - k091413 807.92 (a)(4): Device Description The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for u… | 2009 |
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 23 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- 5 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K073277.
How does its category compare?
All DCN devicesDCN System, Test, C-Reactive Protein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DCN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DCN
234in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCN
7in 2025
MAUDE reports naming product code DCN, 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 | 2 | — | 1 | 0 |
| 2009 | 3 | 111 | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 234 | 0 | 2 |
| 2019 | 0 | — | 1 | 8 |
| 2020 | 1 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Hitachi Clinical Analyzer S TEST reagent cartridge CRP is intended for the quantitative measurement of C-reactive protein in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma. The test system is intended for use in clinical laboratories or physician office laboratories. CRP measurements aid in the evaluation of injury to body tissues, and infection and inflammatory disorders. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113809: Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113809
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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