# K092849: Blood Collection Tube Samples for Use with Point of Care Blood Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Epocal, Inc.
- Decided: Mar 30, 2010 after 195 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: none
- 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K200107: epoc Blood Analysis System (2020), 0 descendants of its own

## 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 heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions. Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis system and are used for the collection and dispensing of capillary blood samples with epoc Test Cards. The Blood Gas Electrolyte (BUE) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct. The Blood Gas Electrolyte (BGEM) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2, Hematocrit - Hct and Glucose - Glu. Measurement of sodium is used in diagnosis and treatment of diseases involving electrolyte imbalance. Measurement of potassium is used in diagnosis and treatment of 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, pO2 (blood gases) is used in the diagnosis and treatment of life-threatening acid-base disturbances. Measurement of Hct distinguishes normal from abnormal states of blood volume, such as anemia and erythrocytosis. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell tumors.

Source page: https://510kreport.com/device/K092849
Methodology: https://510kreport.com/methodology