# K081703: Myglucohealth Glucose Monitoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: Entra Health Systems, Ltd.
- Decided: Jan 8, 2009 after 205 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 K950727 (1995). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072369: Evolution Blood Glucose Monitoring System, Hmd Biomedical, LLC (2008) Summary page 1.

## Most influential descendants
- K113105: Tempusic Patient Monitor (2011), 8 descendants of its own
- K152124: Tempus IC2 (2015), 7 descendants of its own
- K152645: Dictum Health (2016), 6 descendants of its own
- K170798: Dictum Health (2017), 5 descendants of its own
- K192004: Eko Analysis Software (2020), 4 descendants of its own

## Indications for use
The Myglucohealth glucose monitoring system provides a quick and easy way for diabetic patients to measure and self-monitor blood glucose levels. The system is comprised of the MGH-BT1 (w/Bluetooth wireless download capability) or the MGH-1 (w/o Bluetooth) blood glucose meter, control solution and test strips that carry a biosensor used for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated, to allow for easy comparison to the laboratory method. Further, results from either meter may be uploaded to a memory device through a standard RS32 connection, or, with the -BTl model, wirelessly transmitted to a bluetooth capable PC or Cell phone. The Myglucohealth glucose monitoring systems are not to be used for the diagnosis or screening of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.

Source page: https://510kreport.com/device/K081703
Methodology: https://510kreport.com/methodology