# K132406: Elementv Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Infopia Co, Ltd.
- Decided: Apr 18, 2014 after 259 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 K950727 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103021: Element Plus Blood Glucose Monitoring System, Infopia Co, Ltd. (2011) Summary page 3.

## Indications for use
The Element V Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, palm, hand, upper-arm, forearm, calf, and thigh. The Element V Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Element V Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Element V test strips are for use with the Element V meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the finger, palm, hand, upper-arm, forearm, calf and/or thigh. The Element V control solutions are for use with the Element V meter and the Element V test strips to check that the meter and test strips are working together properly and the test is performing correctly. This meter contains some speaking functions but has not been validated for use by the visually impaired. By adding the voice function, users can hear test results, setting conditions and warning messages (errors) while performing the test. This added function is intended to aid users for their convenience.

Source page: https://510kreport.com/device/K132406
Methodology: https://510kreport.com/methodology