510(k) · Cleared
ClearedLFS Lipogel Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zaxis, Inc. · JHO Electrophoretic Separation, Lipoproteins
Cleared on Sep 3, 1996 as substantially equivalent to K833611 (Helena Laboratories, 1984) and 1 other predicate after a 190-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Sep 3, 1996
- Review
- 190 days
- Class
- Class I
- Product code
- JHO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K833611 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK833611 Titan Gel Lipoprotein ElectrophoresisHelena Laboratories · 1984
- This deviceK960785 LFS Lipogel Assay KitZaxis, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833611 | Titan Gel Lipoprotein Electrophoresis | Helena Laboratories | 1984 | — |
| 0 (this device) | K960785 | LFS Lipogel Assay Kit | Zaxis, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
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 JHO? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K833611 | Titan Gel Lipoprotein ElectrophoresisSummary page 3…uments Device LFS Lipogel Titan Gel- Paragon™ Assay Kit Lipoprotein Electrophoresis Electrophoresis System System Lipoprotein Reagent Test Kit 510k Number Current 510(k) K833611 K854057 Principle of | Electrophoresis Electrophoresis Electrophoresis Opexation Components Electronics and | Electronics and Ele… | 1984 |
| * | K854057 | Paragon Electrophoresis Sys Lipoprotein Reagent TESummary page 3…evice LFS Lipogel Titan Gel- Paragon™ Assay Kit Lipoprotein Electrophoresis Electrophoresis System System Lipoprotein Reagent Test Kit 510k Number Current 510(k) K833611 K854057 Principle of | Electrophoresis Electrophoresis Electrophoresis Opexation Components Electronics and | Electronics and Electronics… | 1985 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K833611.
How does its category compare?
All JHO devicesJHO Electrophoretic Separation, Lipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHO
FDA has decided no JHO device since 2007.
Median 510(k) review, days · JHO
Too few JHO 510(k)s in any year since 2007 to give a median.
Recalls per year · JHO
No recall names JHO since 2007.
Adverse event reports per year · JHO
No MAUDE report names JHO 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 | — |
What is it indicated for?
The LFS Lipogel Assay Kit is indicated for the electrophoretic separation of lipoproteins in a gradient polyacrylamide gel. That is, the LFS Lipogel Assay Kit is an in vitro diagnostic device intended to test human plasma or serum for lipoproteins and their subfractions.
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/K960785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960785: LFS Lipogel Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960785
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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