510(k) · Cleared
ClearedEasyra CK-MB Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP Quality Control Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medica Corporation · JHY Colorimetric Method, Cpk Or Isoenzymes
Cleared on May 13, 2014 after a 484-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 13, 2014
- Review
- 484 days
- Class
- Class II
- Product code
- JHY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JHY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JHY devicesJHY Colorimetric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JHY
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · JHY
Too few JHY 510(k)s in any year since 2007 to give a median.
Recalls per year · JHY
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHY
3in 2023
MAUDE reports naming product code JHY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (225 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K130080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130080: Easyra CK-MB Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP Quality Control Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130080
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026