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510(k) Data Aggregation
(417 days)
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.
The BeneCheck™ Premium GLU Monitoring System Kit includes the following: Meter, Blood Glucose Test Strips, Control Solutions, Lancing Device and Lancets.
The BeneCheck™ Premium GLU Meters, GLU Test Strips, and Lancing Device are manufactured by General Life Biotechnology Co., Ltd. The Premium GLU Meter, when used with the Premium GLU Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the BeneCheck™ Premium GLU Monitoring System is verified by the Premium GLU Control Solution.
The BeneCheck™ Premium PRO GLU Monitoring System Kit includes the following: Meter, Blood Glucose Test Strips, and Control Solutions.
The BeneCheck™ Premium GLU and Premium PRO GLU Meters, GLU Test Strips, and Lancing Device are manufactured by General Life Biotechnology Co., Ltd. The GLU Meter, when used with the GLU Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the BeneCheck™ Premium GLU Monitoring System and PRO GLU Monitoring System is verified by the Control Solution.
BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System is an electronic device that utilizes the electrical characteristic technology for measuring the glucose level in human blood. A relatively small drop of blood is placed on a disposable test strip coated with Glucose Oxidase (GOD) which interacts with the software driven meter. Within eight seconds, the level of blood glucose will be shown on the digital display screen. BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System requires only minimum of 0.9 microliter of blood for the testing, therefore it reduces the time and effort required for testing and improves the compliance of diabetic people to their testing regimens
Here's a breakdown of the acceptance criteria and study information for the BeneCheck™ Premium GLU Monitoring System and BeneCheck™ Premium PRO GLU Monitoring System, based on the provided text:
Acceptance Criteria and Device Performance
| Type of Non-Clinical Study | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| Linearity | R² of first order regression should be ≥ 0.99; Glucose concentration level should cover 600 mg/dL | Tested R² is 0.998, 1.000 and 0.998; Tested concentration ranged from 16.2 to 622 mg/dL |
| Precision | Overall CV (within 95% confidence interval) for both within-run and between-day should be ≤5.0% at glucose ≥75mg/dL; Standard deviation ≤ 5.0 mg/dL at glucose 10% when sample volume is below 0.9 µL | |
| Altitude Effect | For venous blood test, bias % should be within ±10% compared to reference value at all glucose concentrations; For glucose control test, bias % of lower and upper limit of 95% CI should be within ±10% at altitude |
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