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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 < 20 mg/dL >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 < 75 mg/dL | All tested CV and SD meet acceptance criteria |
| Interference | Clinically significant interference is defined as maximum bias for each individual test exceeds 10% compared to non-spike control group | Among 26 interference substances, potential significantly interfering substances (including glutathione, levo-dopa) are described in the report and listed under 'Limitations' section of package inserts, user manuals, and labeling. |
| Hematocrit (HCT) Effect | Calculated % bias vs. reference value and normal HCT should be ≤ 15.0% in all tested HCT range and level of glucose | Tested hematocrit range is 30-55%, compared to reference value 42.5% is within bias of ±15% across all glucose measuring levels |
| Specimen Volume | Bias of each individual test for various sample volume should be ≤ 10% compared to reference value | Bias of results are < 10% when sample volume is between 0.9 and 1.5 µL, bias is > 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 <328 feet (100 meters) | Results from sea level to 10,498 feet (3,200 meters) indicate bias from all 3 venous blood levels are all within ±10% vs. reference value; Results at altitude 1,000 and 10,744 feet (3,275 meters) indicate bias within ±10% |
| Operating Temperature and Humidity | Individual concentration bias % compared to reference value at 50 | Tested results indicate individual bias compared to reference value within 10% across all 3 glucose measuring ranges. |
| Test Strip Real Time Stability | Individual % bias compared to reference value should be within ±10% in all 3 tested glucose levels of blood samples | Test results meet accepted criteria, on-going study for 24 months, current data indicates test strips can be stored up to 180 days at 50 |
| Test Strip Accelerated Closed Vial Stability | Individual % bias compared to reference value should be within ±10% in all tested three levels of blood samples | Test results meet accepted criteria, data supports claim that test strips can be stored up to 2 years at 50 |
| Test Strip Open Vial Stability | Individual % bias compared to reference value should be within ±10% in all tested three levels of blood samples | Test results meet accepted criteria, indicates test strips can be used (25 times) over 126 days after opening at 50 |
| Control Solution Real Time Stability | Individual % bias compared to reference value should be within ±10% in all 3 tested glucose levels of blood samples | Test results meet accepted criteria, on-going study for 24 months, current data indicates control solution can be stored up to 75 days at 50 |
| Control Solution Accelerated Closed Vial Stability | Individual % bias compared to reference value should be within ±10% in all tested three levels of blood samples | Test results meet accepted criteria, data supports claim that control solution can be stored up to 2 years at 50 |
| Control Solution Open Vial Stability | Individual % bias compared to reference value should be within ±10% in all tested three levels of blood samples | Test results meet accepted criteria, indicates control solution can be used (25 times) over 120 days after opening at 50 |
| Disinfection Efficacy Validation Study | LoD, Recovery, Interference, Neutralization, and Disinfection tests were conducted to evaluate the efficacy of disinfection procedure with specified disinfectant (Super Sani-Cloth® Germicidal Disposable Wipes) used on blood glucose meter and lancing device. | Results demonstrated that HBV of clinical sera could be efficaciously removed from meter and lancing device following disinfection procedure. Results demonstrated disinfection procedure and virucide is a robust method to protect users from HBV infection. |
| Simulation of Cleaning Cycles Study | For blood glucose meter, a total 24,000 wipes (12,000 cleaning and disinfection cycles) support a minimum 3-year claim for single patient use and multiple patient professional use. Shelf life of blood glucose meter is 3 years. For lancing device, a total of 160 cleaning and disinfection cycles support a minimum 3-year claim for single patient use by performing cleaning and disinfection once a week. Shelf life of lancing device is 5 years. | The device meets these criteria for the specified shelf lives and cleaning cycles. |
| Flesch-Kincaid Readability Assessment | The operating instructions should be written at an eight-grade reading level or below to reach most of the population | Flesch-Kincaid Grade Level Score ranges from 6.1 to 8.2 for CS Insert, Test Strip Insert, User Manual, and Quick Guide, indicating all instructions are expected to be understandable by an average student in 8th grade, therefore meeting requirement of criteria. |
Study Details
The provided text details non-clinical tests and clinical tests to establish the safety and effectiveness of the device.
Clinical Tests
1. System Accuracy Study:
* Sample size for the test set: A total of 123 subjects participated.
* Data provenance: Not explicitly stated (e.g., country of origin). It is a prospective study as subjects "participated" in the study.
* Number of experts used to establish the ground truth and qualifications: Not specified.
* Adjudication method: Not specified.
* MRMC comparative effectiveness study: Not conducted. This study compares the device's performance to a predicate device and a lab instrument.
* Standalone (algorithm only) performance: Yes, the study evaluated the "BeneCheck™ meter" performance against a lab instrument (ground truth).
* Type of ground truth used: Plasma glucose values on a lab instrument. The device's whole blood (plasma equivalent) glucose values were compared to this.
* Sample size for the training set: Not applicable; this is a system accuracy study, not a machine learning model.
* How the ground truth for the training set was established: Not applicable.
2. User Performance Study:
* Sample size for the test set: 152 consumers ("lay consumers").
* Data provenance: Not explicitly stated (e.g., country of origin). It is a prospective study as consumers "performed" the study.
* Number of experts used to establish the ground truth and qualifications: Not specified. The ground truth likely refers to the "OneTouch® Ultra2 Blood Glucose Monitoring System" which is the predicate device.
* Adjudication method: Not specified.
* MRMC comparative effectiveness study: Not conducted in the sense of AI assistance. This study compared user performance with the subject device to user performance with the predicate device.
* Standalone (algorithm only) performance: No, this is a user performance study with human-in-the-loop (the lay consumers).
* Type of ground truth used: Performance for the predicate device, OneTouch® Ultra2 Blood Glucose Monitoring System. The study demonstrated "substantial equivalence" to the predicate.
* Sample size for the training set: Not applicable.
* How the ground truth for the training set was established: Not applicable.
Non-Clinical Tests
The non-clinical tests covered a wide range of performance, functionality, safety, and reliability characteristics (Linearity, Precision, Interference, Hematocrit Effect, Specimen Volume, Altitude Effect, Operating Temperature and Humidity, various Stability tests for test strips and control solutions, Disinfection Efficacy, Cleaning Cycles, and Readability Assessment).
- Sample size for the test set: Not explicitly stated as a single "test set" for all non-clinical studies. Each study would have had its own sample size (e.g., number of measurements, number of test strips, amount of control solution).
- Data provenance: Not explicitly stated, though it mentions studies were "either performed internally by professional personnel in General Life Biotechnology or were contracted to third party." This suggests a controlled laboratory environment. Retrospective or prospective is not directly applicable, though internal testing generally follows a prospective protocol.
- Number of experts used to establish the ground truth and qualifications: Not specified. These tests involve controlled experimental setups and analytical measurements rather than expert human interpretation.
- Adjudication method: Not applicable for these laboratory tests.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Yes, these tests evaluate the device's technical performance in isolation from user-related factors (except for the readability assessment).
- Type of ground truth used: Reference values established through analytical methods and standards for measuring glucose concentration, stability, etc.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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