510(k) · Cleared
ClearedEpoc Chloride Test and Epoc Creatinine Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epocal, Inc. · CGL Electrode, Ion Based, Enzymatic, Creatinine
Cleared on Oct 5, 2012 as substantially equivalent to K001387 (I-Stat Corp., 2000) and 1 other predicate after a 291-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Oct 5, 2012
- Review
- 291 days
- Class
- Class II
- Product code
- CGL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003261 (2000). 3 ancestors in all, the oldest K001387 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK003261 Creatinine PlusRoche Diagnostics Corp. · 2000 · Recalled
- 1 generation backK024098 Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp. · 2002 · Recalled
- This deviceK113726 Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK200107 epoc Blood Analysis SystemEpocal, Inc. · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K200107epoc Blood Analysis SystemEpocal, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003261 | Creatinine Plus | Roche Diagnostics Corp. | 2000 | 1 |
| −1 | K024098 | Cobas Integra Creatinine Plus Ver.2 Assay | Roche Diagnostics Corp. | 2002 | 2 |
| 0 (this device) | K113726 | Epoc Chloride Test and Epoc Creatinine Test | Epocal, Inc. | 2012 | — |
| +1 | K200107 | epoc Blood Analysis System | Epocal, Inc. | 2020 | 19 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 CGL? 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 CGL device
- #1 K261039 i-STAT Crea cartridge with the i-STAT 1 Systemscore 11.9 · 2 generations · no Class I recall
What was it cleared against? (2)
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 3…. epoc Blood Analysis System i-STAT Model 300 510(k) # k113726 K001387 Same Item Device Predicate… | 2000 |
| * | K024098 | Cobas Integra Creatinine Plus Ver.2 AssaySummary page 4…ystem Roche Cobas 510(k) # k113726 K<024098 Item Device Predicate Int… | 2002 |
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 |
|---|---|---|---|
| K200107 | epoc Blood Analysis System | 2020 | 0 |
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.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K200107 (Epocal, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K001387.
How does its category compare?
All CGL devicesCGL Electrode, Ion Based, Enzymatic, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CGL
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · CGL
Too few CGL 510(k)s in any year since 2007 to give a median.
Recalls per year · CGL
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGL
8in 2025
MAUDE reports naming product code CGL, 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 | — | 3 | 17 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 1 | 6 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Chloride 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, venous or capillary whole blood in the laboratory or at the point of care. Chloride measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of electrolyte and metabolic disorders. The…
Read the full statement (144 words)
The Chloride 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, venous or capillary whole blood in the laboratory or at the point of care.
Chloride measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The Creatinine 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, venous or capillary whole blood in the laboratory or at the point of care.
Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal diseases and in monitoring renal dialysis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113726: Epoc Chloride Test and Epoc Creatinine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113726
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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