# K133045: Element TM Lite Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Infopia Co, Ltd.
- Decided: Apr 10, 2014 after 195 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 K950727 (1995). 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)
- K113670: Element Blood Glucose Monitoring System, Infopia Co, Ltd. (2012) Summary page 2.

## Indications for use
The ElementTM Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The ElementTM Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The ElementTM Lite 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 of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The ElementTM Lite Test Strips are for use with the ElementTM Lite Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The ElementTM Lite Control Solutions are for use with the ElementTM Lite Meter and ElementTM Lite Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

Source page: https://510kreport.com/device/K133045
Methodology: https://510kreport.com/methodology