(69 days)
The Sidekick Blood Glucose Test System is intended for the quantitative determination The Glookin' 2100a Diole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Sidekick Blood Glucose Test System
This document is a 510(k) clearance letter from the FDA for a blood glucose test system. It does not contain the detailed study information about acceptance criteria and device performance that you requested. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance (e.g., country of origin, retrospective/prospective), number of experts, and adjudication methods for a test set.
- Details on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
This document is a regulatory clearance, not a clinical study report. To get the information you requested, you would typically need to review the submission's associated clinical and analytical studies, which are not included in this letter.
§ 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.