# K171247: epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test

- Pathway: 510(k) (Traditional)
- Applicant: Epocal, Inc.
- Decided: Jan 17, 2018 after 264 days
- Product code: CDS (Electrode, Ion Specific, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- 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 K053110 (2006). 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)
- K053110: Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge, I-Stat Corporation (2006) Summary page 4.

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

## Indications for use
The Blood Urea Nitrogen and Total Carbon Dioxide tests, 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. Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases. Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance.

Source page: https://510kreport.com/device/K171247
Methodology: https://510kreport.com/methodology