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The AP-3000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes at home. The AP-3000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-3000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, calf, and thigh) for self testing by persons with diabetes. The AP-3000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or diabetes mellitus, and is not intended for use on neonates.

The AP-3000 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-3000 test strips and MAJOR control solution with the AP-3000 Blood Glucose Monitoring System.

The AP-3000multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-3000multi test strips and MAJOR control solution with the AP-3000multi Blood Glucose Monitoring System.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for accuracy or performance metrics. Instead, it makes a general statement about meeting intended use. The table below outlines the performance characteristics mentioned, but without specific numerical targets, it's impossible to directly compare to 'acceptance criteria' in the traditional sense of a specific threshold.

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