510(k) · Cleared
ClearedHDL Cholesterol Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LBT Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Aug 4, 2000 after a 164-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 4, 2000
- Review
- 164 days
- Class
- Class I
- Product code
- LBT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK000568 HDL Cholesterol PlusRoche Diagnostics Corp. · 2000
- Descendant · cites it directly · 2 of its ownK033610 HDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK120662 Piccolo HDL-Capillary Test SystemAbaxis, Inc. · 2012
- 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 ownK032932 Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol…Stanbio Laboratory · 2004
- Descendant · cites it directly · 0 of its ownK014018 Cholesterol 1, 2, 3Imi · 2002
Most influential descendants
Showing 5 of 5 · See all- K033610HDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2003 · cites it directly2descendants
- K120662Piccolo HDL-Capillary Test SystemAbaxis, Inc. · 2012 · 2 generations on0descendants
- K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc. · 2011 · 2 generations on0descendants
- K032932Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol CalibratorStanbio Laboratory · 2004 · cites it directly0descendants
- K014018Cholesterol 1, 2, 3Imi · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000568 | HDL Cholesterol Plus | Roche Diagnostics Corp. | 2000 | — |
| +1 | K033610 | HDL-Cholesterol Plus 2ND Generation | Roche Diagnostics Corp. | 2003 | — |
| +2 | K120662 | Piccolo HDL-Capillary Test System | Abaxis, Inc. | 2012 | — |
| +2 | K111753 | Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL… | Hitachi Chemical Diagnostics, Inc. | 2011 | — |
| +1 | K032932 | Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol Calibrator | Stanbio Laboratory | 2004 | — |
| +1 | K014018 | Cholesterol 1, 2, 3 | Imi | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LBT? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033610 (Roche Diagnostics Corp., 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LBT devicesLBT Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBT
FDA has decided no LBT device since 2007.
Median 510(k) review, days · LBT
Too few LBT 510(k)s in any year since 2007 to give a median.
Recalls per year · LBT
No recall names LBT since 2007.
Adverse event reports per year · LBT
No MAUDE report names LBT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000568 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000568: HDL Cholesterol Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000568
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026