# K041928: HDL-Advance Assay, Cat. NO. 278-20, 278-50A, 278-50B

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Nov 23, 2004 after 127 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For the quantitative determination of high density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. High Density Lipoprotein (HDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Source page: https://510kreport.com/device/K041928
Methodology: https://510kreport.com/methodology