(269 days)
AG-605 & AG-606 Blood Glucose Monitoring System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
AG-605 & AG-606 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates.
AG-605 & AG-606 Blood Glucose Monitoring System consists of a blood glucose meter, test strips, two levels of control solutions, lancets and lancing device.
AG-605 & AG-606 Blood Glucose Monitoring System is designed to provide an easy, accurate method for determining capillary blood glucose values. This analysis is based on amperometric technology using glucose oxidase that is specific for the blood glucose measurement. When the blood sample is applied to the test strip, electrons are formed by the reaction between glucose oxidase and blood glucose. The electrical current is measured by the meter and correlates with the concentration of glucose in the blood sample.
Here's a breakdown of the acceptance criteria and study information for the AG-605 & AG-606 Blood Glucose Monitoring System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary explicitly states that clinical tests were performed and complied with the accuracy requirements of ISO 15197. It also states, "The results meet or exceed the accuracy requirements of ISO 15197." However, the exact numerical acceptance criteria from ISO 15197 and the device's specific numerical performance are not provided in the summary.
To present this in a table, we can only state the standard referenced:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 15197 Accuracy Requirements | Meets or exceeds ISO 15197 accuracy requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "Clinical Tests were performed."
- Data Provenance: Not explicitly stated. It's implied to be from a clinical setting for "capillary whole blood from the fingertips," but the country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. For a blood glucose monitoring system, the "ground truth" is typically established by comparative laboratory reference methods, not human expert consensus in the same way it would be for image-based diagnostic devices.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human readers interpreting medical images or data. For a blood glucose meter, the primary ground truth is established through precise laboratory instrumentation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. An MRMC study is not relevant for a blood glucose monitoring system. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance, typically in image analysis.
- Effect Size: Not applicable.
6. Standalone Performance Study (Algorithm Only)
- Was it done?: Yes, implicitly. The performance of the AG-605 & AG-606 Blood Glucose Monitoring System, as described to meet ISO 15197, is inherently its standalone (algorithm only) performance, as it is a device designed to provide a direct measurement without human interpretation beyond reading the displayed result. The "clinical tests" reported would reflect this.
7. Type of Ground Truth Used
The ground truth for blood glucose monitoring systems is typically established using laboratory reference methods (e.g., YSI glucose analyzer) that are highly accurate and traceable to international standards. While the summary doesn't explicitly name the reference method, "ISO 15197" implicitly refers to a comparison against such a method to establish the accuracy of the device.
8. Sample Size for the Training Set
This information is not provided. Blood glucose meters are not typically "trained" in the same way machine learning algorithms are. The "device" is a biosensor-based system with a fixed enzymatic reaction and electrical current measurement, rather than a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reasons as point 8. The "ground truth" (i.e., known glucose concentrations) would be used during the device's development, calibration, and manufacturing quality control, but not in the context of "training data" for a machine learning model.
§ 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.