# K072249: Easyra Cholesterol Reagent; Easyra Calcium Reagent Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Feb 20, 2008 after 191 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: 1 (0 Class I)
- 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 Cholesterol Reagent: named in the summary without a submission number
- (no number) Cobas Ready Calcium Reagent: named in the summary without a submission number

## Recalls of this device
- Mar 29, 2010 · Not classified · Z-0078-2011: Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results. The defect is a shortened pat

## Indications for use
EasyRA Calcium EasyRA Calcium Reagent is intended for the quantitative determination of total calcium concentration in serum using the Medica EasyRA Chemistry Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). For in-vitro diagnostic use only. For Professional use only. EasyRA Cholesterol The EasyRA Cholesterol Reagent is intended for the quantitative determination of cholesterol in human serum on the Medica EasyRA Chemistry analyzer to screen for elevated cholesterol as a risk factor in coronary artery disease. For in-vitro diagnostic use only. For Professional Use Only.

Source page: https://510kreport.com/device/K072249
Methodology: https://510kreport.com/methodology