(133 days)
The Duet II Glucose Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens. The Duet II Glucose Monitoring System is to be used by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This is in vitro test kit is intended for home use (over the counter).
Duet II Glucose Control Monitoring System
The provided document is a 510(k) clearance letter from the FDA for the Duet II Glucose Control Monitoring System. It does not contain the specific technical performance data, acceptance criteria, or details of a study proving the device meets those criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means its performance has been deemed comparable. However, the letter itself does not provide the performance data or the study details that led to this determination.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need access to the actual 510(k) submission document (or a summary thereof) which typically includes the detailed performance studies.
§ 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.