(262 days)
For single use-
GoodLife AC-300 Blood Glucose Monitoring System
The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-300 Blood Glucose 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 diabetes control. The GoodLife AC-300 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-300 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-300 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-301 Blood Glucose Monitoring System
The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-301 Blood Glucose 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 diabetes control. The GoodLife AC-301 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-301 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-302 Blood Glucose Monitoring System
The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-302 Blood Glucose 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 diabetes control. The GoodLife AC-302 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-302 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-303 Blood Glucose Monitoring System
The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-303 Blood Glucose 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 diabetes control. The GoodLife AC-303 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-303 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-303 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-304 Blood Glucose Monitoring System
The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-304 Blood Glucose 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 diabetes control. The GoodLife AC-304 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-304 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-304 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-305 Blood Glucose Monitoring System
The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-305 Blood Glucose 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 diabetes control. The GoodLife AC-305 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-305 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
For multiple use-
GoodLife AC-300 Professional Blood Glucose Monitoring System
The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-300 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-300 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-300 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-301 Professional Blood Glucose Monitoring System
The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-301 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-301 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-302 Professional Blood Glucose Monitoring System
The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-302 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-302 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-303 Professional Blood Glucose Monitoring System
The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-303 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-303 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-303 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-304 Professional Blood Glucose Monitoring System
The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-304 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-304 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-304 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-305 Professional Blood Glucose Monitoring System
The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-305 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-305 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
GoodLife AC-300305 Blood Glucose Monitoring System and GoodLife AC-300305 Professional Blood Glucose Monitoring System consist of:
(1)Glucose Meter
(2)Glucose Test Strips
(3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
(4)Check Strip
(5)Instruction for use
These models have the same intended use and technological characteristics except the housing of the meter. Although the different shapes of housing, the materials are the same.
[Test Principle]
GoodLife AC-300305 Blood Glucose Monitoring System and GoodLife AC - 300305 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
[Control Solution]
The GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) to assess the performance of the GoodLife AC-300305 with GoodLife AC Blood Glucose Test strips or AC-300305 Professional Blood Glucose monitoring system with AC Professional Blood Glucose Test strips. There are two levels of controls (Levels 1,2).
[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
[Device Calibration]
The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.
The document describes several GoodLife AC-300~305 blood glucose monitoring systems and their professional counterparts. The acceptance criteria and the study proving the device meets them are outlined, primarily referring to consistency with ISO 15197:2003.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device claims compliance with ISO 15197:2003. This international standard sets the requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. While the document does not explicitly list the detailed clauses of ISO 15197:2003 as acceptance criteria, it states that the device is "compliant to the standard" and that "the results demonstrated that the predetermined acceptance criteria were fully met."
Therefore, the acceptance criteria are implicitly those defined by ISO 15197:2003. The document does not provide specific numerical performance metrics from the study to directly compare against these criteria.
| Acceptance Criteria (from ISO 15197:2003 - implied) | Reported Device Performance |
|---|---|
| Accuracy Requirements (e.g., within ±15% or ±20% of a reference method for specified glucose concentrations) | "fully met" the predetermined acceptance criteria. |
| Precision Requirements (e.g., coefficient of variation) | Study conducted according to CLSI/NCCLS EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods |
| Linearity (range) | Study conducted according to CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement. Tested range: 20~600 mg/dL |
| Interference effects | Study conducted according to CLSI EP07-A2: Interference Testing in Clinical Chemistry |
| Method comparison | Study conducted according to CLSI/NCCLS EP09-A2: Method Comparison and Bias Estimation Using Patient Samples |
| Other requirements of ISO 15197:2003 | "fully met" the predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The studies cited (CLSI/NCCLS EP05-A2, EP06-A, EP07-A2, EP09-A2) are guidelines for evaluating the performance of quantitative measurement methods, implying that an established reference method (often laboratory-based) would serve as the ground truth.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For quantitative measurements like blood glucose, adjudication among multiple human readers is typically not applicable in the same way it would be for qualitative assessments (e.g., image interpretation). Instead, the device's readings are compared against a reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging or subjective assessments where multiple human readers interpret cases. Blood glucose monitoring systems are quantitative measurement devices not typically evaluated with MRMC studies in this context. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance described for the blood glucose monitoring system is inherently a standalone performance. The device provides a quantitative measurement of glucose. A "human-in-the-loop" would involve interpretation or decision-making aided by the device's output, but the device's core function is the measurement itself. The studies performed (e.g., accuracy, precision, linearity) evaluate this standalone measurement capability. Therefore, yes, a standalone performance evaluation was done.
7. The Type of Ground Truth Used
Based on the nature of blood glucose monitoring and the CLSI standards referenced, the ground truth would typically be established by a highly accurate laboratory reference method for glucose measurement. The document states a "reference method" is used, which is standard practice in these types of evaluations. The CLSI/NCCLS EP09-A2 standard explicitly deals with "Method Comparison and Bias Estimation Using Patient Samples," which involves comparing the device's results to a more established, accurate method.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. Blood glucose meters are calibrated implicitly during the manufacturing process and through quality control rather than through an "AI training set" in the conventional sense of machine learning algorithms. The calibration involves applying a formula that includes a code parameter specific to the test strip.
9. How the Ground Truth for the Training Set Was Established
The device is calibrated by an "implicit coding process" that occurs when a test strip is inserted. This suggests a pre-programmed calibration based on manufacturing specifications and quality control data rather than a dynamic ground truth established for a "training set" in the machine learning context. The document does not detail how the ground truth for this initial calibration was established, but it would typically involve rigorous laboratory testing against reference methods during the device and strip development and manufacturing stages.
§ 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.