# K153286: iHealth Align Gluco-Monitoring system

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Aug 19, 2016 after 281 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: 6 generations back to K024194 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133790: Ihealth Align Mini Gluco-Monitoring System, Andon Health Co, Ltd. (2014) Summary page 5.

## Indications for use
The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Align Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth Align Gluco-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 iHealth Align Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

Source page: https://510kreport.com/device/K153286
Methodology: https://510kreport.com/methodology