510(k) · Cleared
ClearedApolipoprotein A1 and Apolipoprotein B Reagents and Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pointe Scientific, Inc., · MSJ Apolipoproteins
Cleared on Mar 28, 2007 after a 315-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 28, 2007
- Review
- 315 days
- Class
- Class I
- Product code
- MSJ
- Recalls
- None
- 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 MSJ? 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MSJ devicesMSJ Apolipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MSJ
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MSJ
Too few MSJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MSJ
No recall names MSJ since 2007.
Adverse event reports per year · MSJ
No MAUDE report names MSJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 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 | — |
What is it indicated for?
These products are to be used for the quantitative determination of apolipoprotein Al and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein Al and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061377: Apolipoprotein A1 and Apolipoprotein B Reagents and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061377
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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