510(k) · Cleared
ClearedModified to LDL/HDL Chol Direct Kit-P.N. 4005, 4103,4123
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Morax · JHO Electrophoretic Separation, Lipoproteins
Cleared on Jan 17, 2002 after a 150-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 17, 2002
- Review
- 150 days
- Class
- Class I
- Product code
- JHO
- 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 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?
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 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?
HYDRAGEL LDIL/HDL CHOL Direct K20, HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/MHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol camied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages: electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons, visualization of lipoprotein fractions based on a sensifive…
Read the full statement (268 words)
HYDRAGEL LDIL/HDL CHOL Direct K20, HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/MHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol camied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages:
electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons,
visualization of lipoprotein fractions based on a sensifive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / chalesterol dehydrogenase system coupled with nitro biue tetrazolium chromogen.
The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain relative concentrations of cholesterol in the individual lipoprotein fractions. When the sample’s total cholesterol value is known, cholesterol distribution in g/dL or mol/L. concentrations can be calculated.
The test system is intended for the measurement of the LDL cholesterol and HDL cholesterol. The cholesterol values of only these two fractions are indicated as an aid in the diagnosis and treatment of lipid disorders.
The procedure is indicated for the generat population for a direct measurement of:
the LDL cholesterol level regardless the triglyceride levels
the HDL cholesterol level
the ratio LDL/HDL cholesterol
The HYDRAGEL LDUHDL CHOL Direct K20 kit is designed for use with a manual electrophoresis apparatus, K20. The kit is intended to run up to 7 samples per gel.
The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.
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/K012789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012789: Modified to LDL/HDL Chol Direct Kit-P.N. 4005, 4103,4123.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012789
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026