# K073497: HDL Cholesterol Reagent, Model 10211

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Apr 14, 2008 after 123 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cobas Ready HDL Cholesterol Reagent: named in the summary without a submission number

## Indications for use
The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. The EasyRA HDL Cholesterol calibrator is intended for the one point calibration of the HDL reagent prior to patient serum sample analysis on the EasyRA clinical chemistry analyzer.

Source page: https://510kreport.com/device/K073497
Methodology: https://510kreport.com/methodology