# K101457: Easyplus Mini R9N Self Monitoring Blood Glucose System Model EPS10031

- Pathway: 510(k) (Special)
- Applicant: Eps Bio Technology Corp.
- Decided: Jul 1, 2010 after 36 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 RSN SMBG Test System The EasyPlus mini RON 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. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini RON Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. EasyPlus mini R9N Meter The EasyPlus mini RON Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini RON Blood Glucose Test Strips must be used with the EasyPlus mini RO9N 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. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use inneonates. Alternate Site Testing (AST) in the EasyPlus mini RON Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. EasyPlus mini RSN Blood Glucose Test Strips The EasyPlus mini RON 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 R9N Blood Glucose Test Strips must be used with the EasyPlus mini RON Blood Glucose Meter. Testing isdone 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. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) inthe EasyPlus mini RON Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. EasyPlus mini RSN Glucose Control Solutions For use with the EasyPlus mini RON meter and EasyPlus miini RON Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K101457
Methodology: https://510kreport.com/methodology