# K092887: Easyplus Mini Masterdriver Self Monitoring Blood Glucose System, Model EPS09009

- Pathway: 510(k) (Special)
- Applicant: Eps Bio Technology Corp.
- Decided: Oct 21, 2009 after 30 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
EasyPlus mini MasterDriver SMBG Test System The EasyPlus mini MasterDriver SMBG Test 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 persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. EasyPlus mini MasterDriver Meter The EasyPlus mini MasterDriver Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini MasterDriver Blood Glucose Test Strips must be used with the EasyPlus mini MasterDriver Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. EasyPlus mini MasterDriver Blood Glucose Test Strips The EasyPlus mini MasterDriver Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini MasterDriver Blood Glucose Test Strips must be used with the EasyPlus mini MasterDriver Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. EasyPlus mini MasterDriver Glucose Control Solutions For use with the EasyPlus mini MasterDriver meter and EasyPlus mini MasterDriver Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K092887
Methodology: https://510kreport.com/methodology