# K000568: HDL Cholesterol Plus

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 4, 2000 after 164 days
- Product code: LBT (Electrophoresis, 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033610: HDL-Cholesterol Plus 2ND Generation (2003), 2 descendants of its own
- 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
- K032932: Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol Calibrator (2004), 0 descendants of its own
- K014018: Cholesterol 1, 2, 3 (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K000568
Methodology: https://510kreport.com/methodology