510(k) · Cleared
ClearedEasyra Bilirubin Direct and Total Reagent, Phosphorus Inorganic Reagent and Iron and Magnesium Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medica Corp. · CIG Diazo Colorimetry, Bilirubin
Cleared on Dec 10, 2008 after a 264-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 10, 2008
- Review
- 264 days
- Class
- Class II
- Product code
- CIG
- 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 CIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EasyRA DBIL Reagent is for the in vitro measurement of Direct Bilirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. The EasyRA TBIL Reagent is for the in vitro measurement of Total Bilirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin…
Read the full statement (219 words)
The EasyRA DBIL Reagent is for the in vitro measurement of Direct Bilirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
The EasyRA TBIL Reagent is for the in vitro measurement of Total Bilirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
The EasyRA Phosphorus Reagent is for the in vitro measurement of phosphorus in serum on the Medica EasyRA analyzer. Phosphorus measurements are iised in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance.
The EasyRA Iron Reagent is for the in vitro measurement of iron in serum on the Medica EasyRA analyzer. Iron measurements are used in the diagnosis and treatment of iron deficiency anemia, hemochromatosis, and chronic renal disease.
The EasyRA Magnesium Reagent is for the in vitro measurement of phosphorus in serum on the Medica EasyRA analyzer. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison’s disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K080810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080810: Easyra Bilirubin Direct and Total Reagent, Phosphorus Inorganic Reagent and Iron and Magnesium Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080810
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026