(190 days)
Polymer Technology Systems, Inc. intends to introduce into commercial distribution the MTM BioScanner 1000 Test System for the quantitative determination of glucose in human whole blood when used with the MTM BioScanner G Test Strip. This Monitoring System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
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This document is a 510(k) clearance letter from the FDA for the MTM BioScanner 1000 Test System, a device for quantitatively determining glucose in human whole blood. It confirms the device's substantial equivalence to existing devices. However, this document does not contain the specific details about acceptance criteria, device performance, or study methodology that you requested.
The letter states that the device is for "quantitative determination of glucose in human whole blood when used with the MTM BioScanner G Test Strip" and "is intended to be used to assist the patient and healthcare professional in the management of diabetes." To provide the information you asked for, I would need access to the actual 510(k) submission (K972669) documents, which would include the study details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.
§ 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.