(29 days)
The Hypoguard ADVANCE™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoguard ADVANCE™ Blood Glucose Meter is intended for use with Hypoguard ADVANCE™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoguard ADVANCE™ Blood Glucose Test Strips are intended for use with Hypoguard ADVANCE™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Hypoguard ADVANCE™ Control Solution is intended for use with the Hypoguard ADVANCE™ Meter and Hypoguard ADVANCE™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.
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The provided text is a U.S. FDA 510(k) clearance letter for the Hypoguard ADVANCE™ Blood Glucose Monitoring System. This document does not contain the detailed study information required to answer your prompt thoroughly.
Specifically, the letter states that the device is "substantially equivalent" to legally marketed predicate devices, which implies that its performance is comparable to existing glucose monitoring systems. However, it does not provide the acceptance criteria, the results of specific studies, sample sizes, expert qualifications, or ground truth methods related to the device's performance.
The letter confirms the "Indications For Use" for the Hypoguard ADVANCE™ system, meter, test strips, and control solution, which is that it's for quantitative measurement of glucose in fresh capillary whole blood for in vitro diagnostic use, both at home and in clinical settings, as an aid to monitor diabetes control.
To answer your specific questions, information about performance criteria and study details would typically be found in the 510(k) submission summary or in a separate study report, which is not part of this clearance letter.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- Multi Reader Multi Case (MRMC) comparative effectiveness study, including effect size: Not present. Glucose meters are generally standalone, so an MRMC study with human readers would be exceptionally rare for this type of device.
- Standalone (algorithm only) performance study: While the device is a standalone system, the details of its standalone performance study (e.g., accuracy metrics vs. a reference method) are not provided here.
- Type of ground truth used: Not present, but for blood glucose meters, the ground truth is typically a laboratory reference method (e.g., YSI analyzer).
- Sample size for the training set: Not applicable/not present. For a device like a blood glucose meter, the "training set" in an AI/algorithm sense is less relevant than the design, calibration, and validation against a reference method.
- How the ground truth for the training set was established: Not applicable/not present.
In summary, the provided document is an FDA clearance letter and does not contain the detailed study results needed to answer your questions.
§ 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.