(417 days)
Not Found
No
The description focuses on electrochemical measurement and software interaction for displaying glucose levels, with no mention of AI or ML algorithms for data analysis, interpretation, or prediction.
No.
This device is an in vitro diagnostic device used to measure blood glucose levels, aiding in monitoring a diabetes control program, not directly treating a condition.
No
The intended use explicitly states that the system "should not be used for the diagnosis of, or screening for diabetes." Instead, it is intended "as an aid to monitor the effectiveness of a diabetes control program" for people already diagnosed with diabetes.
No
The device description explicitly states that the system includes a "Meter" which is an electronic device, along with test strips, control solutions, lancing device, and lancets. This indicates the presence of significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states:
- "The BeneCheck™ Premium GLU Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home..."
- "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..."
This clearly indicates that the device is designed to be used outside of the body to examine specimens (blood) from the human body to provide information for medical purposes (monitoring diabetes).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm and forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
BeneCheck™ Premium GLU Monitoring System: single person, self-testing, at home.
BeneCheck™ Premium PRO GLU Monitoring System: multiple-patient use, professional healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were evaluated to establish the performance, functionality, safety and reliability of the BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System. The performed evaluations include:
Linearity and sensitivity, readability assessment, safety test, EMC study, vibration, software risk analysis, precision, specimen volume, interference, altitude effect, system operating condition, hematocrit, test strip and control stability (close vial and open vial), and disinfection study.
These studies and evaluations were either performed internally by professional personnel in General Life Biotechnology or were contracted to third party, performed by qualified personnel, with proper calibrated/maintained equipment and under properly-controlled environmental conditions. All of the evaluated performances passed and meet the acceptance criteria set in the study protocol.
System Accuracy Study: The accuracy study of the BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System was performed by comparing whole blood (plasma equivalent) glucose values on the BeneCheck™ meter with plasma glucose values on the predicate device as well as a lab instrument. A total of 123 subjects participated. The study result demonstrates that the accuracy of BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System met the acceptance criteria.
User Performance Study: A User performance study was performed to demonstrate that lay consumers could obtain accurate results using the subject device. The study was performed by 152 consumers testing capillary whole blood from fingertip, palm and forearm sample sites. The study result shows substantial equivalence to OneTouch® Ultra2 Blood Glucose Monitoring System used in finger, palm and forearm position.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: R² of first order regression should be ≥ 0.99; tested R² is 0.998, 1.000 and 0.998.
Precision: Overall CV (within 95% confidence interval) for both within-run and between-day should be ≤5.0% at glucose ≥75mg/dL; all tested CV meets acceptance criteria. 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; 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. For glucose control test, bias % of lower and upper limit of 95% CI should be within ±10% at altitude
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
General Life Biotechnology Co., Ltd.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92(C)
The Assigned 510(k) number is: K123090
Date of Summary: November 19, 2013
Common Name: BeneCheck™ Premium GLU Monitoring System and BeneCheck™ Premium PRO GLU Monitoring System
| Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW: System, Test, Blood | |||
| Glucose, Over-the-Counter | Class II | 21 CFR 862.1345 | 75 - Chemistry |
| CGA; Glucose Oxidase, Glucose | Class II | 21 CFR 862.1345 | 75 - Chemistry |
| JJX; single (specified) analyte | |||
| controls (assayed and unassayed) | Class I | 21 CFR 862.1660 | 75 - Chemistry |
Applicant:
General Life Biotechnology Co., Ltd. 7F. No. 605, Rui-Guang Rd. Neihu District Taipei City, 114 Taiwan Tel .: 886-2-2205-3698 Fax: 886-2-2208-0779
Contact Persons:
Primary Contact:
Mrs. Feng-Yu Lee (Correspondent for this Application) General Life Biotechnology Co., Ltd. c/o IVDD Regulatory Consultant 27001 La Paz Road Suite 266B Mission Viejo, CA 92691 Tel: (949) 951-3046; Fax: (949) 951-2042 fengyulee@ivddreg.com
Alternate Only:
Jason Su General Life Biotechnology Co., Ltd. 7F. No. 605, Rui-Guang Rd. Neihu District Taipei City, 114 Taiwan Tel.: 886-2-2205-3698 ext.103; Fax: 886-2-2208-0779 jasonsu@glbiotech.com.tw
1
Identification / Product Name:
BeneCheck™ Premium GLU Monitoring System (OTC setting) and BeneCheck™ Premium PRO GLU Monitoring System (POC setting)
Device Description for BeneCheck™ Premium GLU Monitoring System:
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.
Device Description for BeneCheck™ Premium PRO GLU Monitoring System:
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.
Intended Use for BeneCheck™ Premium GLU Monitoring System:
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.
Intended Use for BeneCheck™ Premium PRO GLU Monitoring System:
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
2
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.
Substantial Equivalence (Predicate Kit):
The BeneCheck™ Premium GLU Monitoring System and BeneCheck™ Premium PRO GLU Monitoring System is substantially equivalent to the predicate device noted below: Device Name: OneTouch® Ultra2 Blood Glucose Monitoring System 510k No .: K053529; Device Company: LifeScan, Inc.
Summary of Device Similarities and Differences
The predicate device OneTouch® Ultra2 Blood Glucose Monitoring System and the subject devices BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System are identical in functionality and performance. A comparison chart outlining differences and similarities between the subject device and predicate device is shown below:
3
NOV 2 2 2013
BeneCheck GeneCheck
General Life Biotechnology Co., Ltd.
510(k) SUMMARY (Cont.)
| Similarities and Differences | |||
|---|---|---|---|
| Item | BeneCheck™- | ||
| Premium GLU | |||
| Monitoring System | |||
| (New Device, OTC setting) | BeneCheck™ | ||
| Premium PRO GLU | |||
| Monitoring System | |||
| (New Device. POC setting) | OneTouch® Ultra2 | ||
| Blood Glucose Monitoring System | |||
| (Predicate Device K053529) | |||
| Indications for Use | For single-patient use only, | ||
| in-vitro diagnostic use only | |||
| by individuals with diabetes | |||
| at home | For multiple-patient use by | ||
| health care professional in | |||
| clinical setting | For single-patient use only, in-vitro | ||
| diagnostic use only by individuals | |||
| with diabetes at home; and/or | |||
| multiple-patient use by health care | |||
| professional in clinical setting | |||
| Test Time | 8 seconds | 5 seconds | |
| Measuring Range | 20-600 mg/dL | ||
| Operating Ranges | Temperature 50-104°F (10-40°C) | ||
| Relative Humidity: 10-90% | |||
| Altitude: up to 10,000 feet | |||
| Hematocrit: 30-55% | Temperature 43-111ºF (6-44ºC) | ||
| Relative humidity: 10-90% | |||
| Altitude: up to 10,000 feet | |||
| Hematocrit: 30-55% | |||
| Memory Capacity | 360 test results | 500 test results | |
| Coding | No Coding | Manual selection code number | |
| Storage Conditions | Transportation Storage Temperature: 50-86°F 10-30 °C | ||
| Transportation Storage Humidity: 10-90% | |||
| Meter Dimensions | 57 x 95 x 17.5 mm | 3.12 x 2.25 x 0.9 in | |
| (79 x 57.2 x 22.9 mm) | |||
| Meter Weight | 49.7g with batteries | 1.5 oz (42.5g) with batteries | |
| Unit of measure | mg/dL | ||
| Sample type | Fresh capillary whole blood | ||
| Sample sites | Fingertip, forearm, palm | ||
| Sample volume | 0.9 µL | 1 µL | |
| Monitor | LCD display | ||
| Backlight | No | Yes | |
| Power Supply | CR2032 Battery x1 | CR2032 Battery x2 | |
| Power Saving | Automatic shutoff after 3 minutes of inactivity | Automatic shutoff after 2 minutes of | |
| inactivity | |||
| Control Solution | 3 Levels (1, 2, 3) | ||
| Test Strip | |||
| Technology | Glucose Oxidase (GOD) | ||
| Test Principle | Electrochemical biosensor | ||
| Sample Application | Test strip capillary draw | ||
| Calibration | Plasma-calibrated | ||
| PClink Feature | N/A | Yes, download results using | |
| OneTouch Diabetes Management | |||
| Software |
8-4 Revised 11/19/2013
4
Statement of No Differences:
For the reasons mentioned above, it can be concluded that the BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System is substantially equivalent to the OneTouch® Ultra2 Blood Glucose Monitoring System in commercial distribution, with respect to indications for use and technology.
Technology Characteristics:
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
Discussion of Non-Clinical Tests Performed:
Non-clinical tests were evaluated to establish the performance, functionality, safety and reliability of the BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System. The performed evaluations include:
Linearity and sensitivity, readability assessment, safety test, EMC study, vibration, software risk analysis, precision, specimen volume, interference, altitude effect, system operating condition, hematocrit, test strip and control stability (close vial and open vial), and disinfection study.
These studies and evaluations were either performed internally by professional personnel in General Life Biotechnology or were contracted to third party, performed by qualified personnel, with proper calibrated/maintained equipment and under properly-controlled environmental conditions. All of the evaluated performances passed and meet the acceptance criteria set in the study protocol.
Discussion of Clinical Tests Performed:
System Accuracy Study:
The accuracy study of the BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System was performed by comparing whole blood (plasma equivalent) glucose values on the BeneCheck™ meter with plasma glucose values on the predicate device as well as a lab instrument.
A total of 123 subjects participated. The study result demonstrates that the accuracy of BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System met the acceptance criteria.
User Performance Study:
A User performance study was performed to demonstrate that lay consumers could obtain accurate results using the subject device. The study was performed by 152 consumers testing capillary whole blood from fingertip, palm and forearm sample sites. The study result shows substantial equivalence to OneTouch® Ultra2 Blood Glucose Monitoring System used in finger, palm and forearm position.
5
· Performance:
The results of aforementioned studies demonstrate satisfactory performance of BeneCheck™ Premium GLU Monitoring System (OTC) and Premium PRO GLU Monitoring System (POC), and the device is easy to use and the results are understandable by the target users.
The following table summarizes the results from all the non-clinical testing of the BeneCheck™ Premium GLU Monitoring System and Premium PRO GLU Monitoring System.
| Type of Non-Clinical Study | Acceptance Criteria; Summary of Results |
|---|---|
| Linearity | R² of first order regression should be ≥ 0.99; tested R² is 0.998, 1.000 and 0.998 Glucose concentration level should cover 600 mg/dL; 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; all tested CV meets acceptance criteria 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; 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 For glucose control test, bias % of lower and upper limit of 95% CI should be within ±10% at altitude |