# K130080: Easyra CK-MB Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP Quality Control Material

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corporation
- Decided: May 13, 2014 after 484 days
- Product code: JHY (Colorimetric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EasyRA Creatine Kinase-MB (CK-MB) Reagent is intended for the quantitative determination of CK-MB activity in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements of CK-MB activity are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. For in vitro diagnostic use only. For prescription use only. Medica's EasyRA C-Reactive Protein (CRP) Reagent is intended for use in the quantitative in-vitro diagnostic determination of C-reactive protein in human serum or plasma using the EasyRA clinical chemistry analyzer. Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in-vitro diagnostic use only. For prescription use only. The EasyCAL C-Reactive Protein (CRP) Calibrator Kit is used for calibrating the CRP assay on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA CRP Reagent. The CRIP calibrators are used to establish points of reference that are used in the determination of values in the measurement of CRP in human serum and plasma. For in-vitro diagnostic use only. For prescription use only. The EasyQC C-Reactive Protein (CRP) Quality Control Materials are intended for use as quality control material for the CR? turbidimetric assay, using the EasyRA CRIP Reagent and calibrator kit on the EasyRA clinical chemistry analyzer. For in-vitro diagnostic use only. For prescription use only.

Source page: https://510kreport.com/device/K130080
Methodology: https://510kreport.com/methodology