# K102678: Andon Health Care Management System Software, AG-608 Single & AG-608 Multi Blood Glucose Monitoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: Andon Medical Co., Ltd.
- Decided: Aug 26, 2011 after 344 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: 2 generations back to K001907 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070941: Clever Chek Health Care System Software, Version 1.0, Taidoc Technology Corporation (2007) Summary page 1.

## Most influential descendants
- K112738: Andon Health Care Management System Software (2011), 0 descendants of its own

## Indications for use
Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management. Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. The AG-608 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. The AG-608 MULTI Blood Glucose Monitoring System is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control. The AG-608 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The AGS-1 000 MULTI Blood Glucose Test Strips are for use with the AG-608 MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample. This system should only be used with single-use, auto-disabling lancing devices. The AG-608 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. The AG-608 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AG-608 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-608 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The AGS-1000 Single Blood Glucose Test Strips are for use with the AG-608 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

Source page: https://510kreport.com/device/K102678
Methodology: https://510kreport.com/methodology