# K120813: Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Andon Medical Co., Ltd.
- Decided: Dec 7, 2012 after 263 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: 4 generations back to K024194 (2003). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110017: AG-608N Blood Glucose Monitoring System, Andon Medical Co., Ltd. (2012) Summary page 1.

## Most influential descendants
- K123935: Ihealth BG5/BG5L Wireless Smart Glucose Monitoring System (2013), 3 descendants of its own
- K153278: Wireless Smart Gluco-Monitoring System (2016), 2 descendants of its own
- K133790: Ihealth Align Mini Gluco-Monitoring System (2014), 2 descendants of its own
- K170231: iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) (2017), 1 descendant of its own
- K181070: iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) (2019), 0 descendants of its own

## Indications for use
iHealth BG3 Smart Gluco-Monitoring System is intended to be used for: * quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh * single person measurement only and should not be shared * self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control The iHealth 6G3 Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly. The AGS1 0001 test strips are intended for use with the iHealth BG3 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealthBG3 meter

Source page: https://510kreport.com/device/K120813
Methodology: https://510kreport.com/methodology