510(k) · Cleared
ClearedHitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Chemical Diagnostics, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Dec 14, 2011 as substantially equivalent to K060373 (Roche Diagnostics, 2006) and 5 other predicates after a 175-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Dec 14, 2011
- Review
- 175 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K842280 (1984). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK842280 TDX DigitoxinAbbott Laboratories · 1984
- 1 generation backK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- This deviceK111753 Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol…Hitachi Chemical Diagnostics, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| −1 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| 0 (this device) | K111753 | Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL… | Hitachi Chemical Diagnostics, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 CHH? 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 CHH device
- #1 K251091 Lipidsscore 10.9 · 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? (6)
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 |
|---|---|---|---|
| * | K060373 | Cobas 6000 Series SystemSummary page 1…ss I Reserved, per 21 CFR 862.9(c)(4) 807.92 (a)(3): Identification of the legally marketed predicate devices Instrmmn portion: Roche/Hitachi cobas 6000- K060373 Total cholesterol: Roche/Hitachi test reagent- K03 1824 HDL: Roche/Hitachi test reagent- K033610… | 2006 |
| * | K031824 | Cobas Integra Cholesterol Gen. 2Summary page 1…of the legally marketed predicate devices Instrmmn portion: Roche/Hitachi cobas 6000- K060373 Total cholesterol: Roche/Hitachi test reagent- K03 1824 HDL: Roche/Hitachi test reagent- K033610 LDL: Roche/Hitachi test reagent- KO012287… | 2003 |
| * | K033610 | HDL-Cholesterol Plus 2ND GenerationSummary page 1…Instrmmn portion: Roche/Hitachi cobas 6000- K060373 Total cholesterol: Roche/Hitachi test reagent- K03 1824 HDL: Roche/Hitachi test reagent- K033610 LDL: Roche/Hitachi test reagent- KO012287… | 2003 |
| * | K012287 | Modification to: Cobas Integra LDL-Cholesterol Plus 2ND GenerationSummary page 1…Total cholesterol: Roche/Hitachi test reagent- K03 1824 HDL: Roche/Hitachi test reagent- K033610 LDL: Roche/Hitachi test reagent- KO012287 Page Ilofl14… | 2001 |
| * | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsSummary page 2…Ar~CHI Inspire the Next TG: Roche/Hitachi test reagent- K972250 Jntep~rated system (instrument and lipid panel): Alfa Wasserman S40 system- K09 1413 807.92 (… | 1997 |
| * | K091413 | S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015…Summary page 2…TG: Roche/Hitachi test reagent- K972250 Jntep~rated system (instrument and lipid panel): Alfa Wasserman S40 system- K09 1413 807.92 (a)(4): Device Description The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for us… | 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 27 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- 9 of the 15 ancestors have a recall of any class.
- 5 other devices also cite its predicate K060373.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Hitachi Clinical Analyzer with S TEST reagent cartridges for total cholesterol (CHO), HDL cholesterol (HDL), LDL cholesterol (LDL), and triglycerides (TG) is intended for the quantitative measurements of CHO, HDL, LDL, and TG in serum or heparinized plasma. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. * Cholesterol measurements are used in the diagnosis and treatment…
Read the full statement (160 words)
The Hitachi Clinical Analyzer with S TEST reagent cartridges for total cholesterol (CHO), HDL cholesterol (HDL), LDL cholesterol (LDL), and triglycerides (TG) is intended for the quantitative measurements of CHO, HDL, LDL, and TG in serum or heparinized plasma. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
* Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, and lipid and lipoprotein metabolism disorders.
* HDL measurements (lipoproteins) are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
* LDL measurements (lipoproteins) are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
* Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111753: Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111753
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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