# K153561: AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Feb 16, 2017 after 430 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.
No later device cites it as a predicate yet.
0 of 5 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 5.

## Indications for use
The AG-607 blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The AG-607 blood glucose monitoring system is intended to be used by a Single person and should not be shared. The AG-607 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-607 blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly). The EGS-2003 test strips are for use with the AG-607 blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh. The AG-607Multi blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The AG-607Multi 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 and aid to monitor the effectiveness of diabetes control program. The system is only used with single-use auto-disabling lancing device. The AG-607Multi blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly). The EGS-2003 test strips are for use with the AG-607Multi blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.

Source page: https://510kreport.com/device/K153561
Methodology: https://510kreport.com/methodology