# K061597: Epoc Blood Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Epocal, Inc.
- Decided: Sep 27, 2006 after 111 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001387 (2000). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 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.

## Most influential descendants
- K191360: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 5 descendants of its own
- K210958: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2021), 3 descendants of its own
- K223755: i-STAT G cartridge with the i-STAT 1 System (2023), 1 descendant of its own
- K252488: ABL90 FLEX PLUS System (2026), 0 descendants of its own
- K230300: i-STAT CG8+ cartridge with the i-STAT 1 System (2023), 0 descendants of its own

## Recalls of this device
- Dec 12, 2022 · Class II · Z-1214-2023: pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
- Oct 16, 2008 · Not classified · Z-0952-2009: elevated range of potassium levels

## Indications for use
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 whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium - Na, Potassium - K, ionized Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct. Measurement of Sodium and Potassium are used in diagnosis and treatment diseases involving electrolyte imbalance. Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Measurement of ph pCO2, p 0 2 (blood gases) is used in the diagnosis and treatment of life-threatening acid-base disturbances. Measurement Hot distinguish normal from abnormal states of blood volume, such as anemia and erythrocytosis.

Source page: https://510kreport.com/device/K061597
Methodology: https://510kreport.com/methodology