510(k) · Cleared
Recalled · Class II · 2015Cobas Integra Cholesterol Gen. 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Jul 9, 2003 as substantially equivalent to K952127 (Boehringer Mannheim Corp., 1995) after a 26-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 9, 2003
- Review
- 26 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952127 (1995). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK952127 Boehringer Mannheim Cholesterol AssayBoehringer Mannheim Corp. · 1995 · Recalled
- This deviceK031824 Cobas Integra Cholesterol Gen. 2Roche Diagnostics Corp. · 2003
- Descendant · cites it directly · 0 of its ownK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
- Descendant · cites it directly · 0 of its ownK132031 Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014
- Descendant · cites it directly · 0 of its ownK130200 Piccolo Total Cholesterol - Capillary Test SystemAbaxis, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK111753 Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol…Hitachi Chemical Diagnostics, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018 · cites it directly0descendants
- K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014 · cites it directly0descendants
- K130200Piccolo Total Cholesterol - Capillary Test SystemAbaxis, Inc. · 2013 · cites it directly0descendants
- K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952127 | Boehringer Mannheim Cholesterol Assay | Boehringer Mannheim Corp. | 1995 | 1 |
| 0 (this device) | K031824 | Cobas Integra Cholesterol Gen. 2 | Roche Diagnostics Corp. | 2003 | — |
| +1 | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
| +1 | K132031 | Afinion Lipid Panel and Afinion Lipid Panel Control | Axis-Shield Poc AS | 2014 | — |
| +1 | K130200 | Piccolo Total Cholesterol - Capillary Test System | Abaxis, Inc. | 2013 | — |
| +1 | K111753 | Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL… | Hitachi Chemical Diagnostics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K952127 | Boehringer Mannheim Cholesterol AssaySummary page 1…cholesterol in serum and plasma. Predicate We claim substantial equivalence to the currently marketed Rochemitachi Device Cholesterol Assay. (K952127). 23 5111(k) Summa… | 1995 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2015 | Class II | Z-1921-2015 | Under Investigation by firm | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K181373 (Laboratory Corporation of America Holdings, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 cassette COBAS Integra Cholesterol Gen2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of total cholesterol in serum and plasma
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in blood and lipid and lipoprotein metabolism disorders,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031824: Cobas Integra Cholesterol Gen. 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031824
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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