(244 days)
The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The EASY CHECK Blood Glucose Monitoring System is designed to provide an easy, accurate method for determining capillary blood glucose values. This analysis is based on amperometric technology using glucose oxidase that is specific for the blood glucose measurement. When the blood sample is applied to the test strip, electrons are formed by the reaction between glucose oxidase and blood glucose. The electrical current is measured by the meter and correlates with the concentration of glucose in the blood sample.
The EASY CHECK Blood Glucose Monitoring System consists of the Meter, Test strips with instructions, Lancing device with instructions, Lancets, Code card, 3-Volt Lithium Coin Battery, Users Guide, Log Book, Carrying case and EASY CHECK Control Solutions (level 1 and level 2)
Here's an analysis of the provided text regarding the acceptance criteria and study for the EASY CHECK Blood Glucose Monitoring System:
This document primarily serves as a 510(k) summary for the FDA, focusing on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the comprehensive study results in the format requested. While it mentions "clinical testing" for accuracy and comparability, the actual acceptance criteria along with their corresponding performance results are not explicitly laid out in a table in the provided text.
However, based on the general information provided for a blood glucose monitoring system, we can infer some aspects of what would likely constitute acceptance criteria and how performance was evaluated.
Response:
Based on the provided text, the report does not explicitly list a table of acceptance criteria with corresponding device performance results in the requested format. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a detailed breakdown of performance against predefined acceptance criteria.
However, it does state that "Sensitivity, precision, linearity and other tests were used to demonstrate the performance and reliability of EASY CHECK Blood Glucose Monitoring System." It also mentions "Consumer (field) testing was done to prove that the EASY CHECK Blood Glucose Monitoring System is easy to use by lay people and also that test results are accurate and comparable to a laboratory reference method and to the predicate device."
Without specific numerical targets for "sensitivity, precision, and linearity" and their achieved values, a direct table of acceptance criteria and reported device performance cannot be generated.
Given the context of a blood glucose meter, typical acceptance criteria would be based on ISO 15197 (or a similar standard in place at the time of submission) which outlines accuracy requirements. For example, for glucose concentrations
§ 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.