# K112272: EM44 Self Monitoring Blood Glucose System, EM44 Pro Self Monitoring Blood Glucose System

- Pathway: 510(k) (Special)
- Applicant: Eps Bio Technology Corp.
- Decided: Sep 7, 2011 after 30 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 EM44 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 EM44 meter and the EM44 test strips. The EM44 meter only is used with the EM44 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EM44 Glucose Control Solution For use with EM44 Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results. The EM44 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. 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 EM44 Pro meter and the EM44 Pro test strips. The EM44 Pro meter only is used with the EM44 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip. The EM44 Glucose Control Solution For use with EM44 Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K112272
Methodology: https://510kreport.com/methodology