# K113726: Epoc Chloride Test and Epoc Creatinine Test

- Pathway: 510(k) (Traditional)
- Applicant: Epocal, Inc.
- Decided: Oct 5, 2012 after 291 days
- Product code: CGL (Electrode, Ion Based, Enzymatic, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003261 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001387: I-Stat Portable Clinical Analyzer, Model 300, I-Stat Corp. (2000) Summary page 3.
- K024098: Cobas Integra Creatinine Plus Ver.2 Assay, Roche Diagnostics Corp. (2002) Summary page 4.

## Most influential descendants
- K200107: epoc Blood Analysis System (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K113726
Methodology: https://510kreport.com/methodology