# K093297: Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube

- Pathway: 510(k) (Traditional)
- Applicant: Epocal, Inc.
- Decided: Jun 9, 2010 after 231 days
- Product code: KHP (Acid, Lactic, Enzymatic Method)
- Device class: 1
- Regulation: 21 CFR 862.1450
- Recalls of this device: 1 (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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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 2.

## Most influential descendants
- K200107: epoc Blood Analysis System (2020), 0 descendants of its own
- K200492: i-STAT CG4+ Cartridge with the i-STAT 1 System (2020), 0 descendants of its own

## Recalls of this device
- Mar 13, 2013 · Class II · Z-1971-2013: This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of

## Indications for use
The Lactate 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 in hospitals, nursing homes or other clinical care institutions. Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Source page: https://510kreport.com/device/K093297
Methodology: https://510kreport.com/methodology