# K102345: Easymax T1 Self Monitoring Blood Glucose System, Model EPS10042

- Pathway: 510(k) (Special)
- Applicant: Eps Bio Technology Corp.
- Decided: Jun 21, 2011 after 306 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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 EasyMax TI Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in Vitro diagnostic use). It is indicated for multiple-patient use in a professional healthcare setting, 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 EasyMax TI Pro Meter and the EasyMax TI Pro Blood Glucose Test Strips. The EasyMax Ti Pro Meter is only used with the EasyMax Ti Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips. EasyMax TI Glucose Control Solutions For use with the EasyMax Ti Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results. The EasyMax TI Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips 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 EasyMax TI Meter and the EasyMax TI Blood Glucose Test Strips. The EasyMax Ti Meter is only used with the EasyMax Ti test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm. EasyMax TI Glucose Control Solutions For use with the EasyMax Ti 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/K102345
Methodology: https://510kreport.com/methodology