(157 days)
The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
The Easy Pain Supreme Self-Monitoring Blood Glucose System consists of the Easy Pain Supreme meter, Easy Pain Supreme Glucose Test Strips, Auto-Lancet Device, Check Strip, Code Card, and Control Solution.
Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not explicitly state formal "acceptance criteria" in a separate section. Instead, the performance characteristics are presented as findings from analytical and comparison studies. The implicit acceptance criteria are that the device's performance should be comparable to or within acceptable limits relative to the predicate device and established analytical standards. Below is a summary of the key performance metrics reported:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Precision (Within-Run) | Low CV% for various glucose concentration levels. (Generally, CV% |
§ 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.