(29 days)
The On Call Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, forearm and palm. The On Call Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto-disabling lancing devices.
The On call Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly).
The On Call Pro Blood Glucose Test Strips are used with the On Call Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.
Not Found
The provided document is a 510(k) clearance letter for a medical device (On Call Pro Blood Glucose Monitoring System) and its "Indications for Use" statement. It does not contain information about the detailed acceptance criteria and study results, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device itself.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device has been cleared based on its substantial equivalence to a predicate device, not necessarily on a new clinical study demonstrating specific performance metrics against an acceptance criterion in the level of detail requested.
Therefore, I cannot provide the requested information based solely on the text provided. Such details are typically found in the accompanying 510(k) summary or clinical study reports, which are not included in this document.
§ 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.