510(k) · Cleared
ClearedHydragel 7,15,30, Chol-HDL Kit
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 Oct 27, 1997 after a 150-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 27, 1997
- Review
- 150 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 CHOL-HDL, HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for quantification of the cholesterol carried by the individual lipoproteins of human plasma or serum. This analysis is performed by electrophoresis on alkaline buffered (pH 9.4) agarose gels. The separated lipoproteins are visualized by a cholesterol-specific enzymatic reaction. The stained electrophoregrams are to be interpreted visually to confirm…
Read the full statement (266 words)
HYDRAGEL CHOL-HDL, HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for quantification of the cholesterol carried by the individual lipoproteins of human plasma or serum. This analysis is performed by electrophoresis on alkaline buffered (pH 9.4) agarose gels. The separated lipoproteins are visualized by a cholesterol-specific enzymatic reaction. The stained electrophoregrams are to be interpreted visually to confirm identification of the individual fractions and by 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/l or mol/l concentrations can be calculated. Since the HDL cholesterol assay is of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL fraction.
All HYDRAGEL CHOL-HDL kits utilize the same composition of alkaline buffered HYDRAGEL CHOL-HDL agarose gels and the same procedure. It is carried out 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 HYDRAGEL CHOL-HDL kit is designed for use with a manual electrophoresis apparatus. The kit is intended to run up to 8 samples per gel.
The HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL 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/K972015 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972015: Hydragel 7,15,30, Chol-HDL Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972015
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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