510(k) · Cleared
Recalled · Class II · 2015Modification to:Cobas Integra HDL-Cholesterol Plus 2ND Generation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Aug 8, 2001 as substantially equivalent to K963213 (Boehringer Mannheim Corp., 1996) after a 19-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 8, 2001
- Review
- 19 days
- Class
- Class I
- Product code
- LBS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963213 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK963213 Boehringer Mannheim Direct HDL-CholesterolBoehringer Mannheim Corp. · 1996 · Recalled
- This deviceK012286 Modification to:Cobas Integra HDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2001
- Descendant · cites it directly · 0 of its ownK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
Most influential descendants
Showing 1 of 1 · See all- K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963213 | Boehringer Mannheim Direct HDL-Cholesterol | Boehringer Mannheim Corp. | 1996 | 1 |
| 0 (this device) | K012286 | Modification to:Cobas Integra HDL-Cholesterol Plus 2ND Generation | Roche Diagnostics Corp. | 2001 | — |
| +1 | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LBS? 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 |
|---|---|---|---|
| * | K963213 | Boehringer Mannheim Direct HDL-CholesterolSummary page 1…sterol Classification name: Lipoprotein test system We claim substantial equivalence to the currently marketed Roche/Hitachi HDL-Cholesterol plus 2nd generation assay (K963213). The HDL-Cholesterol plus 2nd Generation test principle uses magnesium sulfate and dextran sulfate to form water-soluble comple… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181373 | Extended Lipid Panel Assay | 2018 | 0 |
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-1925-2015 | 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)… |
| Jun 11, 2008 | Not classified | Z-0010-2009 | Labeling Change Control | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LBS devicesLBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBS
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · LBS
118in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBS
6in 2025
MAUDE reports naming product code LBS, 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 | 0 |
| 2008 | 3 | 129 | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 3 | 118 | 0 | 3 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The cassette COBAS Integra HDL-Cholesterol plus 2nd Generation (HDL-C) contains an
in vitro diagnostic reagent system intended for use on COBAS Integra systems for the
quantitative determination of HDL-cholesterol concentration in serum and plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and
plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid
disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal 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/K012286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012286: Modification to:Cobas Integra HDL-Cholesterol Plus 2ND Generation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012286
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026