# K133790: Ihealth Align Mini Gluco-Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: May 22, 2014 after 164 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: 5 generations back to K024194 (2003). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120813: Blood Glucose Monitoring System, Andon Medical Co., Ltd. (2012) Summary page 2.

## Most influential descendants
- K153286: iHealth Align Gluco-Monitoring system (2016), 0 descendants of its own
- K150833: iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System (2015), 0 descendants of its own

## Indications for use
The iHealth Align Gluco-Monitoring system (BG1) 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 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. iHealth Blood Glucose Test Strips (AGS-10001) are intended for use with the iHealth Align Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG1 meter.

Source page: https://510kreport.com/device/K133790
Methodology: https://510kreport.com/methodology