510(k) · Cleared
ClearedSynchron LX Systems Apolipoprotein (Apoa and Apob) Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · MSJ Apolipoproteins
Cleared on Apr 21, 1997 as substantially equivalent to K862386 (Beckman Instruments, Inc., 1986) after an 87-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Apr 21, 1997
- Review
- 87 days
- Class
- Class I
- Product code
- MSJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K862386 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK862386 Ics Apolipoprotein B Reagent Test KitBeckman Instruments, Inc. · 1986
- This deviceK970314 Synchron LX Systems Apolipoprotein (Apoa and Apob) ReagentsBeckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862386 | Ics Apolipoprotein B Reagent Test Kit | Beckman Instruments, Inc. | 1986 | — |
| 0 (this device) | K970314 | Synchron LX Systems Apolipoprotein (Apoa and Apob) Reagents | Beckman Instruments, Inc. | 1997 | — |
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 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K860201 | FDA’s K860201 is Parenteral Administration Set Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1986 |
| * | K862386 | Ics Apolipoprotein B Reagent Test KitSummary page 1…icate 3eagents ' Company Apolipoprotein A-1 Beckman Beckman K86201 (ApoA) Reagent Apolipoprotein A-1 Instruments, Inc. (APA) Reagent Apolipoprotein B Beckman Beckman K862386 (ApoB) Reagent Apolipoprotein B Instruments, Inc. (APB) Reagent apo510k.sse 1/97 Beckman Instruments, Inc., Sec… | 1986 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K862386.
How does its category compare?
All MSJ devicesMSJ Apolipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The SYNCHRON LX Systems Apolipoprotein A-1 (ApoA) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein A-1 in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
The SYNCHRON LX Systems Apolipoprotein B (ApoB) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein B in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
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/K970314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970314: Synchron LX Systems Apolipoprotein (Apoa and Apob) Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970314
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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