(55 days)
The On Call® Express Voice Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steadystate times (when blood glucose level is not changing rapidly).
The On Call® Express Voice Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.
The On Call® Express Voice Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
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The provided text describes the FDA 510(k) clearance for the On Call® Express Voice Blood Glucose Monitoring System but does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria.
The document is a clearance letter and an "Indications for Use" statement. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its intended use. However, it does not include the performance data, study design, or specific thresholds that would typically be found in a study report.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets them based solely on the provided text. The requested information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth type, training set size, and training set ground truth establishment is not present in this document.
To obtain that information, one would typically need to refer to the full 510(k) submission, which is not provided here.
§ 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.