# K103021: Element Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Infopia Co, Ltd.
- Decided: Nov 4, 2011 after 388 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.
3 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)
- K072369: Evolution Blood Glucose Monitoring System, Hmd Biomedical, LLC (2008) Summary page 1.

## Most influential descendants
- K113670: Element Blood Glucose Monitoring System (2012), 1 descendant of its own
- K132406: Elementv Blood Glucose Monitoring System (2014), 0 descendants of its own
- K133045: Element TM Lite Blood Glucose Monitoring System (2014), 0 descendants of its own

## Indications for use
The Element TM plus Blood Glucose Monitoring System is for the quantitative measurement of glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. Element "mplus Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Element T plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Element TM plus Blood Glucose Monitoring System is intended for self testing outside the hody (in vitro diagnostic use) by people with diabetes at home as an aid in the management of diabetes. Alternative site Testing (ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh) should be done during steady- state times when glucose is not changing rapidly. The Elemen t TM plus Test Strips are for use with the ElementM plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. This meter contains some speaking functions but has not been validated for use by the visually impaired.

Source page: https://510kreport.com/device/K103021
Methodology: https://510kreport.com/methodology