510(k) · Cleared
Recalled · 2003HDL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Jun 11, 1998 as substantially equivalent to K963213 (Boehringer Mannheim Corp., 1996) after a 38-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.
- Decided
- Jun 11, 1998
- Review
- 38 days
- Class
- Class I
- Product code
- LBS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963213 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK963213 Boehringer Mannheim Direct HDL-CholesterolBoehringer Mannheim Corp. · 1996 · Recalled
- This deviceK981580 HDLAbbott Laboratories · 1998
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) | K981580 | HDL | Abbott Laboratories | 1998 | — |
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 2…ero HDLfIwp 0000012 Substantial Equivalence: The Direct HDL assay is substantially equivalent to the Boehringer Mannheim® Direct HDL-Cholesterol assay (K963213) on the Hitachi® 717 Analyzer. These assays yield similar Performance Characteristics. Similarities: « Both assays are in vitro… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2003 | Not classified | Z-0803-03 | Other | Degredation prior to expiry date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K963213.
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 Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol levels in human serum or plasma. Low Direct HDL measurements are used in the diagnosis and treatment of coronary artery disease.
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/K981580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981580: HDL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981580
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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