# K032932: Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Stanbio Laboratory
- Decided: Mar 10, 2004 after 170 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 K000568 (2000). 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)
- K000568: HDL Cholesterol Plus, Roche Diagnostics Corp. (2000) Summary page 1.
- (no number) HDL/LDL Cholesterol Plus Calibrator (Roche): named in the summary without a submission number

## Indications for use
Direct HDL Cholesterol LiquiColor ® and Direct HDL'LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

Source page: https://510kreport.com/device/K032932
Methodology: https://510kreport.com/methodology