510(k) · Cleared
ClearedHydragel LDL/HDL Chol Direct Kit-P.N. 4005, Hydragel 7 LDL/HDL Chol Direct Kit-P.N. 4103, Hydragel LDL/HDL Chol Direct 0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Morax · LBT Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Jun 18, 1999 after a 143-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 18, 1999
- Review
- 143 days
- Class
- Class I
- Product code
- LBT
- 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 LBT? 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 LBT devicesLBT Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBT
FDA has decided no LBT device since 2007.
Median 510(k) review, days · LBT
Too few LBT 510(k)s in any year since 2007 to give a median.
Recalls per year · LBT
No recall names LBT since 2007.
Adverse event reports per year · LBT
No MAUDE report names LBT 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 LDL/HDL CHOL DIRECT, HYDRAGEL 7 LDIYHDL CHOL DIRECT and HYDRAGEL LDL/HDL CHOL DIRECT 15/30 kits are designed for quantification of the cholesterol carried by the LDL and HDL lipoprotein fractions of human plasma or serum. The analysis is performed in two stages: - electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present, - visualization of lipoprotein fractions based on a sensitive and…
Read the full statement (270 words)
HYDRAGEL LDL/HDL CHOL DIRECT, HYDRAGEL 7 LDIYHDL CHOL DIRECT and HYDRAGEL LDL/HDL CHOL DIRECT 15/30 kits are designed for quantification of the cholesterol carried by the LDL and HDL lipoprotein fractions of human plasma or serum. The analysis is performed in two stages:
- electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present,
- visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic method involving cholesterol esterase and cholesterol oxidase, and a chromogenic system with reduced AEC (amino ethyl carbazole) and peroxidase.
The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain accurate, relative concentrations of cholesterol in the individual lipoprotein fractions If the sample’s total cholesterol value is known, cholesterol distribution in g/dL or mol/L concentrations can be calculated. Since the LDL cholesterol and HDL cholesterol assays are of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL and LDL fractions.
The procedure is indicated for the general 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 LDL/HDL CHOL Direct kit is designed for use with 2 manual electrophoresis apparatus. The kit is intended to run up to 8 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/K990250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990250: Hydragel LDL/HDL Chol Direct Kit-P.N. 4005, Hydragel 7 LDL/HDL Chol Direct Kit-P.N. 4103, Hydragel LDL/HDL Chol Direct 0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990250
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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