510(k) · Cleared
Recalled · Class II · 2013Blood Gas, Electrolyte and Metabolite Test Card
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epocal, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Jun 24, 2009 as substantially equivalent to K001387 (I-Stat Corp., 2000) after a 160-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 3 times.
- Decided
- Jun 24, 2009
- Review
- 160 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001387 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001387 I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 2000 · Recalled
- This deviceK090109 Blood Gas, Electrolyte and Metabolite Test CardEpocal, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001387 | I-Stat Portable Clinical Analyzer, Model 300 | I-Stat Corp. | 2000 | 13 |
| 0 (this device) | K090109 | Blood Gas, Electrolyte and Metabolite Test Card | Epocal, Inc. | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001387 | I-Stat Portable Clinical Analyzer, Model 300Summary page 2…Device EPOC Blood Analysis System i-STAT Model 300 510(k) # To be determined K001387 Same / Item Device Predicate Different Int… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2013 | Class II | Z-1971-2013 | Nonconforming Material/Component | This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl).… |
| Jun 28, 2011 | Class II | Z-2034-2012 | Device Design | Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot… |
| Oct 27, 2010 | Not classified | Z-1287-2011 | Other | Potential for out of specification star grind teeth. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K001387.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Glucose test, as part of the epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial or venous whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.
Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090109: Blood Gas, Electrolyte and Metabolite Test Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090109
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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