# K100010: HDL Cholesterol (HDLX) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 14, 2010 after 130 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
Longest line of descent: 1 generation back to K040692 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040692: Olympus HDL Cholesterol Reagent, OSR6195/OSR6295 and Olympus HDL Cholesterol Calibrator ODC0023, Olympus America, Inc. (2004) Summary page 3.

## Indications for use
HDLX reagent, when used in conjunction with SYNCHRON LX®9 System(s), UniCe1® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

Source page: https://510kreport.com/device/K100010
Methodology: https://510kreport.com/methodology