# K070053: Easyplus Mini Self Monitoring Glucose Test System, Models R1 and R2

- Pathway: 510(k) (Traditional)
- Applicant: Eps Bio Technology Corp.
- Decided: Dec 3, 2007 after 333 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
Longest line of descent: 1 generation back to K032552 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032552: Accu-Chek Advantage System, Roche Diagnostics Corp. (2003) Summary page 1.

## Indications for use
The EasyPlus mini Self Monitoring Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, and forearm by using Easy Plus mini Monitoring Blood Glucose Monitoring System. The device is not intended for testing neonate blood samples. The EasyPlus mini Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini Blood Glucose Test Strips must be used with the EasyPlus mini 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. The EasyPlus mini 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 Blood Glucose Test Strips must be used with the EasyPlus mini 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. For use with the EasyPlus mini meter and EasyPlus mini Blood Glucose Test Strips as a quality control check to vfify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K070053
Methodology: https://510kreport.com/methodology