# K160365: BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Infopia Co, Ltd.
- Decided: Sep 28, 2016 after 232 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: 2 generations back to K062058 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130181: Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring System, Infopia Co, Ltd. (2013) Summary page 5.

## Indications for use
BLE Smart Blood Glucose Monitoring System The BLE Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The BLE Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The BLE Smart 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 BLE Smart Blood Glucose Test Strips are for use with the BLE Smart 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 BLE Smart Blood Glucose Control Solutions are for use with the BLE Smart Blood Glucose Monitoring System to check that the meter and test strips are working together properly and the test is performing correctly. BLE Smart Professional Blood Glucose Monitoring System The BLE Smart Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The BLE Smart Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The BLE Smart Professional Blood Glucose Monitoring System 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 BLE Smart Professional Blood Glucose Test Strips are for use with the BLE Smart Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The BLE Smart Professional Blood Glucose Control Solutions are for use with the BLE Smart Professional Blood Glucose Monitoring System to check that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K160365
Methodology: https://510kreport.com/methodology