# K132966: Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Infopia Co, Ltd.
- Decided: Dec 5, 2013 after 76 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.
4 later devices descend from it; 3 cite 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)
- K130181: Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring System, Infopia Co, Ltd. (2013) Summary page 2.

## Most influential descendants
- K182286: Oh'Care Lite Smart Blood Glucose Monitoring System (2018), 1 descendant of its own
- K203562: Finetest Lite Blood Glucose Monitoring System (2021), 0 descendants of its own
- K201396: Finetest Lite Smart Blood Glucose Monitoring System (2020), 0 descendants of its own
- K150274: GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System (2015), 0 descendants of its own

## Indications for use
The GluNEO 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 GluNEO Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The GluNEO 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 GluNEO Lite Test Strips are for use with the GluNEO 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 GluNEO Lite Control Solutions are for use with the GluNEO Lite Meter and GluNEO Lite Test Strips to check that the meter and test strips are working together properly and the test is performing correctly. The GluNEO Lite 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 GluNEO Lite 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 GluNEO Lite 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 GluNEO Lite Professional Test Strips are for use with the GluNEO Lite 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 GluNEO Lite Professional Control Solutions are for use with the GluNEO Lite Professional Meter and GluNEO Lite Professional Test Strips 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/K132966
Methodology: https://510kreport.com/methodology