510(k) · Cleared
Recalled · Class II · 2015Modification to: Cobas Integra LDL-Cholesterol Plus 2ND Generation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · MRR System, Test, Low Density, Lipoprotein
Cleared on Aug 7, 2001 as substantially equivalent to K974733 (Boehringer Mannheim Corp., 1998) after an 18-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 7, 2001
- Review
- 18 days
- Class
- Class I
- Product code
- MRR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974733 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK974733 Boehringer Mannheim Direct LDL - CholesterolBoehringer Mannheim Corp. · 1998 · Recalled
- This deviceK012287 Modification to: Cobas Integra LDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2001
- Descendant · cites it directly · 0 of its ownK111753 Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol…Hitachi Chemical Diagnostics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK032936 Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL…Stanbio Laboratory · 2004
Most influential descendants
Showing 2 of 2 · See all- K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc. · 2011 · cites it directly0descendants
- K032936Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol CalibratorStanbio Laboratory · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974733 | Boehringer Mannheim Direct LDL - Cholesterol | Boehringer Mannheim Corp. | 1998 | 1 |
| 0 (this device) | K012287 | Modification to: Cobas Integra LDL-Cholesterol Plus 2ND Generation | Roche Diagnostics Corp. | 2001 | — |
| +1 | K111753 | Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL… | Hitachi Chemical Diagnostics, Inc. | 2011 | — |
| +1 | K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol… | Stanbio Laboratory | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2011 | 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 MRR? 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 MRR device
- #1 K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica®…score 8.0 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K974733 | Boehringer Mannheim Direct LDL - CholesterolSummary page 1…sterol Classification name: Lipoprotein test system We claim substantial equivalence to the currently marketed Roche/Hitachi LDL-Cholesterol plus 2nd generation assay (K974733). The LDL-Cholesterol plus 2nd Generation test principle is based on the selective micellary solubilization of LDL-cholesterol b… | 1998 |
What descends from it? (2)
2 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-1927-2015 | 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-0006-2009 | 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 MRR devicesMRR System, Test, Low Density, Lipoprotein: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRR
Too few MRR 510(k)s in any year since 2007 to give a median.
Recalls per year · MRR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRR
1in 2024
MAUDE reports naming product code MRR, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The cassette COBAS Integra LDL-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 LDL-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/K012287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012287: Modification to: Cobas Integra LDL-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/K012287
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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