# K110017: AG-608N Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Andon Medical Co., Ltd.
- Decided: Jan 18, 2012 after 380 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: 3 generations back to K024194 (2003). 3 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093262: AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring System, Andon Medical Co., Ltd. (2010) Summary page 3.

## Most influential descendants
- K120813: Blood Glucose Monitoring System (2012), 7 descendants of its own
- 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

## Indications for use
The AG-608N Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AG-608N single Blood Glucose Monitoring System is intended for 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 AG-608N single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The AGS-iQOOON single Test Strips are for use with the AG-608N single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N control solutions are intended for use with the AG-608N single Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the bottles. The AG-608N MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is only used with single-use lancing devices. The AG-608N MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly). The AGS-100ON MULTI Test Strips are for use with the AG-608N MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N control solutions are intended for use with the AG-608N MULTI Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

Source page: https://510kreport.com/device/K110017
Methodology: https://510kreport.com/methodology