# K162593: HDL-Cholesterol Gen.4

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Oct 19, 2016 after 33 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 K021316 (2002). 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)
- K021316: Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator, Genzyme Corp. (2002) Summary page 5.

## Indications for use
In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. 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/K162593
Methodology: https://510kreport.com/methodology