# K113670: Element Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Infopia Co, Ltd.
- Decided: May 8, 2012 after 147 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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.

## Most influential descendants
- K133045: Element TM Lite Blood Glucose Monitoring System (2014), 0 descendants of its own

## Indications for use
The Element T' Blood Glucose Monitoring System is fot 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 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 TmBlood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Element 'T' Blood Glucose Monitoring System is intended for self testing outside the body (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 Element Tm Test Strips are for use with the ElemenJ"' 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. The ElmntT control solutions are for use with the Element TMBlood Glucose Monitoring system to check that the meter and the test strips are working together properly and the test is performing correctly.

Source page: https://510kreport.com/device/K113670
Methodology: https://510kreport.com/methodology