# K050632: Advia Ims Direct HDL Cholesterol Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: May 26, 2005 after 78 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. The FDA summary names its predicate without a number.
- (no number) Bayer ADVIA 1650 Direct HDL Cholesterol: named in the summary without a submission number

## Indications for use
The Bayer ADVIA IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.

Source page: https://510kreport.com/device/K050632
Methodology: https://510kreport.com/methodology