(233 days)
The Smart Dongle Blood Glucose Monitoring System consists of the Smart Dongle meter, single test strips, and the Smart Dongle mobile application as the display component of the Smart Dongle Blood Glucose Monitoring System. The Smart Dongle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger. This blood glucose monitoring system is intended to be used by a single person and should not be shared. Smart Dongle Blood Glucose Monitoring System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
The system consists of blood glucose meter, test strips and mobile platform (as a display of the system). And, the blood glucose meter is compatible to iPhone series, including iPhone 4, iPhone 4s, iPhone 5, iPhone 5s, iPhone 6, iPhone 6 plus, iPhone 6s plus. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Smart Dongle Blood Glucose Test Strips can be used only with the Smart Dongle Blood Glucose Monitoring System.
This document is a 510(k) premarket notification for the Smart Dongle Blood Glucose Monitoring System. It describes the device, its intended use, and performance characteristics to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Smart Dongle Blood Glucose Monitoring System appear to be based on accuracy performance metrics, specifically comparing the device's readings to reference measurements. While explicit "acceptance criteria" are not phrased as such, the results presented imply the thresholds the device aims to meet.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| **For glucose concentration |
§ 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.