# K033610: HDL-Cholesterol Plus 2ND Generation

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 5, 2003 after 18 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K120662: Piccolo HDL-Capillary Test System (2012), 0 descendants of its own
- K111753: Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride (2011), 0 descendants of its own

## Indications for use
HDL-C plus 2 generation is an enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on automated clinical chemistry analyzers. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Source page: https://510kreport.com/device/K033610
Methodology: https://510kreport.com/methodology