# K140325: Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Joinsoon Medical Technology Co, Ltd.
- Decided: Oct 13, 2015 after 610 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 K072543 (2007). 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)
- K072543: Onetouch Select Blood Glucose Monitoring System, Lifescan, Inc. (2007) Summary page 5.

## Indications for use
The Joinsoon® EON L Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Joinsoon® EON L Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting as an aid to monitor the effectiveness of diabetes control. The Joinsoon® EON L Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The Joinsoon® EON L Glucose Monitoring System is intended to be used by a single person and should not be shared. The Joinsoon® Single Strips are for use with the Joinsoon® EON L Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips. The Joinsoon® Control Solution is for use with the Joinsoon® EON L Glucose Meter and Joinsoon® Single Strips as a quality control check to verify that the meter and test strips are working together properly, and that the test is performing correctly. The Joinsoon® EON LS Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Joinsoon® EON LS Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting as an aid to monitor the effectiveness of diabetes control. The Joinsoon® EON LS Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The Joinsoon® EON LS Glucose Monitoring System is intended to be used by a single person and should not be shared. The Joinsoon® Snap Strips are for use with the Joinsoon® EON LS Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips. The Joinsoon® Control Solution is for use with the Joinsoon® EON LS Glucose Meter and Joinsoon® Snap Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K140325
Methodology: https://510kreport.com/methodology