510(k) · Cleared
Recalled · Class III · 2018Autohdl Cholesterol Reagent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pointe Scientific, Inc., · LBR Ldl & Vldl Precipitation, Hdl
Cleared on Aug 5, 1999 after a 51-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 13 times.
- Decided
- Aug 5, 1999
- Review
- 51 days
- Class
- Class I
- Product code
- LBR
- Recalls
- 13
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| Aug 10, 2018 | Class III | Z-0389-2019 | Error in labeling | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. |
| Mar 13, 2015 | Class III | Z-2764-2015 | Nonconforming Material/Component | Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance. |
| Jan 29, 2009 | Not classified | Z-1200-2009 | Nonconforming Material/Component | The R1 reagent has microbial contamination. |
| Jan 29, 2009 | Not classified | Z-1201-2009 | Nonconforming Material/Component | The R1 reagent has microbial contamination. |
| Sep 18, 2006 | Not classified | Z-0074-2007 | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Sep 18, 2006 | Not classified | Z-0075-2007 | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Sep 18, 2006 | Not classified | Z-0076-2007 | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Jun 12, 2006 | Not classified | Z-1454-06 | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Jun 12, 2006 | Not classified | Z-1457-06 | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Jun 12, 2006 | Not classified | Z-1455-06 | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Jun 12, 2006 | Not classified | Z-1458-06 | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Jun 12, 2006 | Not classified | Z-1459-06 | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Jun 12, 2006 | Not classified | Z-1456-06 | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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?
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma. HDL cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart disease. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992002: Autohdl Cholesterol Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992002
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026