510(k) · Cleared
Recalled · Class II · 2015Boehringer Mannheim Direct HDL-Cholesterol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Oct 23, 1996 after a 68-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 23, 1996
- Review
- 68 days
- Class
- Class I
- Product code
- LBS
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK963213 Boehringer Mannheim Direct HDL-CholesterolBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 1 of its ownK012286 Modification to:Cobas Integra HDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2001 · Recalled
- Descendant · 2 generations on · 0 of its ownK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
- Descendant · cites it directly · 0 of its ownK982767 Raichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol CalibratorRaichem · 1998
- Descendant · cites it directly · 0 of its ownK981580 HDLAbbott Laboratories · 1998 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K012286Modification to:Cobas Integra HDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2001 · cites it directly1descendant
- K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018 · 2 generations on0descendants
- K982767Raichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol CalibratorRaichem · 1998 · cites it directly0descendants
- K981580HDLAbbott Laboratories · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963213 | Boehringer Mannheim Direct HDL-Cholesterol | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K012286 | Modification to:Cobas Integra HDL-Cholesterol Plus 2ND Generation | Roche Diagnostics Corp. | 2001 | 2 |
| +2 | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
| +1 | K982767 | Raichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol Calibrator | Raichem | 1998 | — |
| +1 | K981580 | HDL | Abbott Laboratories | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 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 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 |
|---|---|---|---|
| * | — | Boehringer Mannheim HDL Cholesterol Named without a submission number |
What descends from it? (4)
3 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-1924-2015 | 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?
- Of its descendants, K012286 (Roche Diagnostics Corp., 2001) has gone furthest, with 1 descendant of its own.
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?
Boehringer Mannheim Direct HDL is intended for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
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/K963213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963213: Boehringer Mannheim Direct HDL-Cholesterol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963213
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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