# K090109: Blood Gas, Electrolyte and Metabolite Test Card

- Pathway: 510(k) (Traditional)
- Applicant: Epocal, Inc.
- Decided: Jun 24, 2009 after 160 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (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.
No later device cites it as a predicate yet.
0 of 2 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.

## 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
- Jun 28, 2011 · Class II · Z-2034-2012: Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined tha
- Oct 27, 2010 · Not classified · Z-1287-2011: Potential for out of specification star grind teeth.

## Indications for use
The Glucose 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 or venous whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions. Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell tumors.

Source page: https://510kreport.com/device/K090109
Methodology: https://510kreport.com/methodology