(17 days)
The Evencare® Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. It is intended for use outside the body by diabetics at home and in clinical settings as an aid to monitor the effectiveness of diabetes control.
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The provided text is a 510(k) clearance letter from the FDA for a blood glucose monitoring system. It confirms substantial equivalence but does not contain specific details about the acceptance criteria, study design, or performance metrics.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on the regulatory clearance for the EvenCare® Blood Glucose Monitoring System, indicating it is substantially equivalent to legally marketed predicate devices for the quantitative measurement of glucose in fresh capillary whole blood for diabetic monitoring.
§ 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.