510(k) · Cleared
Recalled · 2010Easyra Clinical Chemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medica Corp. · CGA Glucose Oxidase, Glucose
Cleared on Aug 30, 2007 after a 237-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 30, 2007
- Review
- 237 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK070057 Easyra Clinical Chemistry AnalyzerMedica Corp. · 2007
- Descendant · cites it directly · 0 of its ownK093357 Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica…Diamond Diagnostics, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093357Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module…Diamond Diagnostics, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070057 | Easyra Clinical Chemistry Analyzer | Medica Corp. | 2007 | — |
| +1 | K093357 | Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise… | Diamond Diagnostics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093357 | Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module… | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2010 | Not classified | Z-0078-2011 | Other | 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 path length at specific cuvette positions… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093357 (Diamond Diagnostics, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EasyRA clinical analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na + (sodium), K + (potassium), Cl- (chloride), Li + (lithium) and Glucose (Trinder method) in human serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. Sodium measurements are used in the diagnosis and treatment diseases involving…
Read the full statement (158 words)
The EasyRA clinical analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na + (sodium), K + (potassium), Cl- (chloride), Li + (lithium) and Glucose (Trinder method) in human serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lithium measurements are used to assure that the proper drug dosage is administered in the treatment of patients ith mental disturbances, such as manic-depressive illness (bipolar disorder).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K070057 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070057: Easyra Clinical Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070057
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026