# K150274: GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Infopia Co, Ltd.
- Decided: Aug 26, 2015 after 203 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: 3 generations back to K062058 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132966: Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring System, Infopia Co, Ltd. (2013) Summary page 5.

## Indications for use
The GDH Professional LED 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 venous whole blood. The GDH Professional LED 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 GDH Professional LED Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady – state times (when glucose is not changing rapidly). The GDH Professional test strips are for use with the GDH Professional LED meter to quantitatively measure glucose (sugar) 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 GDH Professional control solutions are for use with the GDH Professional LED meter and GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly. The GDH 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 venous whole blood. The GDH 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 GDH Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady – state times (when glucose is not changing rapidly). The GDH Professional test strips are for use with the GDH Professional meter to quantitatively measure glucose (sugar) 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 GDH Professional control solutions are for use with the GDH Professional meter and GDH 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/K150274
Methodology: https://510kreport.com/methodology