# K990581: Direct HDL-Cholesterol Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Jun 18, 1999 after 115 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
The K-ASSAY Direct HDL-Cholesterol reagent is intended for the quantitative in vitro determination of HDL-cholesterol in serum or plasma which is used in the diagnosis and treatment of lipid disorders. The K-ASSAY Direct HDL-Cholesterol calibrator is intended to be used for the calibration of the K-ASSAY Direct HDL-Cholesterol assay.

Source page: https://510kreport.com/device/K990581
Methodology: https://510kreport.com/methodology