# K123090: GLB Benecheck Premium Glu Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: General Life Biotechnology Co., Ltd.
- Decided: Nov 22, 2013 after 417 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: 1 generation back to K053529 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053529: Onetouch Ultra 2 Blood Glucose Monitoring System, Lifescan, Inc. (2006) Summary page 3.

## Indications for use
The BeneCheck™ Premium GLU Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm and forearm. The BeneCheck™ Premium GLU Monitoring System is intended to be used by a single person and should not be shared. The BeneCheck™ Premium GLU Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of a diabetes control program. The BeneCheck™ Premium GLU Monitoring System should not be used for the diagnosis of, or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The BeneCheck™ Premium GLU Test Strips are for use with the BeneCheck™ Premium GLU Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm. The BeneCheck™ Premium GLU Control Solutions are for use with the BeneCheck™ Premium GLU Meter and BeneCheck™ Premium GLU Test Strips to verify that the meters and test strips are working together properly and that the test performs properly. The BeneCheck™ Premium PRO GLU Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm and forearm. The BeneCheck™ Premium PRO GLU 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 a diabetes control program. The system should only be used with single-use, auto-disabling lancing devices. The BeneCheck™ Premium PRO GLU Monitoring System should not be used for the diagnosis of, or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The BeneCheck™ Premium PRO GLU Test Strips are for use with the BeneCheck™ Premium GLU PRO Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm. The BeneCheck™ Premium PRO GLU Control Solutions are for use with the BeneCheck™ Premium PRO GLU Meter and BeneCheck™ Premium PRO GLU Test Strips to verify that the meters and test strips are working together properly and that the test performs properly.

Source page: https://510kreport.com/device/K123090
Methodology: https://510kreport.com/methodology