510(k) · Cleared
Recalled · Class II · 2015Boehringer Mannheim Direct LDL - Cholesterol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LBR Ldl & Vldl Precipitation, Hdl
Cleared on Jan 26, 1998 after a 39-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 26, 1998
- Review
- 39 days
- Class
- Class I
- Product code
- LBR
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK974733 Boehringer Mannheim Direct LDL - CholesterolBoehringer Mannheim Corp. · 1998
- Descendant · cites it directly · 2 of its ownK012287 Modification to: Cobas Integra LDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2001 · Recalled
- Descendant · cites it directly · 0 of its ownK143691 LDLC3 LDL-Cholesterol Gen.3Roche Diagnostics Operations (Rdo) · 2015
- Descendant · 2 generations on · 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 ownK040693 PTS Panels LDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK032936 Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL…Stanbio Laboratory · 2004
Most influential descendants
Showing 5 of 5 · See all- K012287Modification to: Cobas Integra LDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2001 · cites it directly2descendants
- K143691LDLC3 LDL-Cholesterol Gen.3Roche Diagnostics Operations (Rdo) · 2015 · cites it directly0descendants
- K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc. · 2011 · 2 generations on0descendants
- K040693PTS Panels LDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2004 · cites it directly0descendants
- K032936Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol CalibratorStanbio Laboratory · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974733 | Boehringer Mannheim Direct LDL - Cholesterol | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K012287 | Modification to: Cobas Integra LDL-Cholesterol Plus 2ND Generation | Roche Diagnostics Corp. | 2001 | 2 |
| +1 | K143691 | LDLC3 LDL-Cholesterol Gen.3 | Roche Diagnostics Operations (Rdo) | 2015 | — |
| +2 | K111753 | Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL… | Hitachi Chemical Diagnostics, Inc. | 2011 | — |
| +1 | K040693 | PTS Panels LDL Cholesterol Test Strips | Polymer Technology Systems, Inc. | 2004 | 1 |
| +2 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 LBR? 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 |
|---|---|---|---|
| * | — | Equal Diagnostics LDL Direct Liquid Select™ Cholesterol Test Named without a submission number |
What descends from it? (5)
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-1928-2015 | 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, K012287 (Roche Diagnostics Corp., 2001) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LBR devicesLBR Ldl & Vldl Precipitation, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LBR
Too few LBR 510(k)s in any year since 2007 to give a median.
Recalls per year · LBR
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBR
8in 2025
MAUDE reports naming product code LBR, 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 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 4 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or 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/K974733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974733: Boehringer Mannheim Direct LDL - Cholesterol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974733
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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