(107 days)
The GO Glucose Monitoring System is intended for the quantitative, colorimetric determination of glucose in whole blood specimens. The GO Glucose Monitoring System is intended for use by people with diabetes to monitor their blood glucose levels in a home use setting. This in vitro test kit is indicated for home use (over the counter).
GO Glucose Monitoring System
This document is a marketing approval letter for the "GO Glucose Monitoring System" and does not contain detailed information about the acceptance criteria or a study proving that the device meets those criteria. Such information is typically found in the 510(k) submission itself, which is a much larger document.
Therefore, I cannot directly answer your request using the provided text.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: The letter only states that the device is "substantially equivalent" to predicate devices. It does not list specific performance metrics (e.g., accuracy percentages, precision, bias) or the thresholds for those metrics (acceptance criteria).
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of these details are present in this regulatory approval letter. These would be part of the clinical and analytical studies submitted to the FDA to demonstrate safety and effectiveness.
To answer your request, you would need access to the actual 510(k) submission document (K991754) for the GO Glucose Monitoring System, which would contain the study protocols, results, and detailed methodologies.
§ 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.