# K041090: HDL-EX Seiken Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Denka Seiken Co., Ltd.
- Decided: Oct 29, 2004 after 186 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 K021316 (2002). 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)
- K021316: Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator, Genzyme Corp. (2002) Summary page 1.

## Indications for use
The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.

Source page: https://510kreport.com/device/K041090
Methodology: https://510kreport.com/methodology