# K072395: Diazyme HDL-Cholesterol Reagent,Calibrator, Controls

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Jan 3, 2008 after 129 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 1.

## Indications for use
The Diazyme HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease.

Source page: https://510kreport.com/device/K072395
Methodology: https://510kreport.com/methodology