(170 days)
The Rightest Blood Glucose Monitoring System GM280B is intended to the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM280B is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM280B 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 diabetes control. The Rightest Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Rightest Blood Glucose Test Strip GS280 is used with Rightest meter GM280B for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The GE Blood Glucose Monitoring System 182 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 182 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 182 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 diabetes control. The GE Blood Glucose Monitoring System 182 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 182 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Rightest Blood Glucose Monitoring System GM280 is intended to the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM280 is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM280 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 diabetes control. The Rightest Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Rightest Blood Glucose Test Strip GS280 is used with Rightest meter GM280 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The GE Blood Glucose Monitoring System 180 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 180 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 180 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 diabetes control. The GE Blood Glucose Monitoring System 180 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 180 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Rightest and GE Blood Glucose Monitoring System series consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.
The Rightest Blood Glucose Meter GM280 and Rightest Blood Glucose Meter GM280B, when used with the Rightest Blood Glucose Test Strips GS280, quantitatively measure glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM280 and Rightest Blood Glucose Monitoring System GM280B are verified by the Rightest Control Solution GC550.
The GE Blood Glucose Meter 180 and GE Blood Glucose Meter 182, when used with the GE Blood Glucose Test Strips 180, quantitatively measure glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 180 and GE Blood Glucose Monitoring System 182 are verified by the Rightest Control Solution GC550.
The provided text describes the acceptance criteria and the study conducted for the GE Blood Glucose Monitoring System series.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The main criterion for a glucose monitoring system's accuracy is typically measured against a laboratory reference method. For this device, the acceptance criteria relates to the accuracy of the blood glucose measurements compared to the YSI 2300 Plus Glucose Analyzer.
Acceptance Criteria and Reported Device Performance (System Accuracy Study)
| Criterion Category | Acceptance Criterion (Implicit from success statement) | Reported Device Performance (Implicit from success statement) |
|---|---|---|
| System Accuracy | The accuracy of the Rightest Blood Glucose Monitoring System GM280 met the acceptance criteria (specific numerical criteria not detailed in the provided text, but commonly derived from ISO 15197 standards for blood glucose monitoring systems). | The study results demonstrate that the accuracy of Rightest Blood Glucose Monitoring System GM280 met the acceptance criteria. |
| User Accuracy & Ease of Use | The user accuracy and ease of use met the acceptance criteria (specific numerical criteria not detailed). | The study results demonstrate that the user accuracy and ease of use (via participant questionnaire scoring) Rightest Blood Glucose Monitoring System GM280B met the acceptance criteria. |
Note: The exact numerical acceptance criteria for system accuracy (e.g., percentage of readings within a certain deviation from the reference) are not explicitly stated in the provided documents but are implied to have been met. For such devices, commonly, the ISO 15197 standard for blood glucose monitoring systems is referenced, which specifies accuracy requirements (e.g., 95% of results must be within ±15 mg/dL for glucose concentrations
§ 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.