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The AUTO-CHEK Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm. thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The AUTO-CHEK Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The AUTO-CHEK Blood Glucose Test Strips are for use with the AUTO-CHEK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites. The AUTO-CHEK Control Solutions are for use with the AUTO-CHEK Meter and AUTO-CHEK Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.

The AUTO-CHEK Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The system consists of the followings: the AUTO-CHEK Meter, AUTO-CHEK Test Strips, AUTO-CHEK Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately), a Lancing Device, Lancets, a User's manual, and a Logbook.

Here's an analysis of the provided text regarding the AUTO-CHEK Blood Glucose Monitoring System, focusing on acceptance criteria and study details. It's important to note that the provided document is a 510(k) summary for a "Special 510(k)" and primarily focuses on demonstrating substantial equivalence to a predicate device after a modification. Therefore, it does not contain extensive details about new clinical studies that would typically describe the acceptance criteria and performance as if it were a de novo submission.

The document states: "The validations were conducted in order to verify that the modified electric connector pattern has not caused any adverse effects on the safety and effectiveness of the candidate device. The test results showed that the candidate device operated effectively, accurately, and safely." This implies that the 'acceptance criteria' were likely tied to demonstrating that the modified device performed equivalently to the predicate device, which would have previously met certain accuracy standards.

The document also mentions "performance, safety, and effectiveness of the device for its intended use" as being met, but it doesn't quantify these.

Acceptance Criteria and Reported Device Performance

Given the nature of this document (a special 510(k) for minor modification), specific numerical acceptance criteria and a detailed performance table from new clinical studies are not explicitly provided.

However, for blood glucose monitoring systems, the generally accepted performance criteria (often referenced by organizations like ISO 15197) involve accuracy within certain bounds compared to a laboratory reference method. Since this document states "The test results showed that the candidate device operated effectively, accurately, and safely," and claims substantial equivalence to the predicate "COOL Blood Glucose Monitoring System," it implicitly means it met the accuracy standards expected of such devices.

Based on typical regulatory expectations for glucose meters, hypothetical (but not explicitly stated in the document) acceptance criteria and their implied fulfillment would be:

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