# K113243: EM50 Self Monitoring Blood Glucose System

- Pathway: 510(k) (Traditional)
- Applicant: Eps Bio Technology Corp.
- Decided: Mar 28, 2012 after 147 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EM5O Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions. The system consists of the EMSO meter and the EMSO test strips. The EM5O meter only is used with the EM5O test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EM5O Glucose Control Solution For use with EM5O Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K113243
Methodology: https://510kreport.com/methodology