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The EasyPlus mini EasyMax Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The EasyPlus mini EasyMax Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The EasyPlus mini EasyMax Blood Glucose Test Strips , are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter IOTCI) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The EasyPlus mini EasyMax Glucose Normal/High Control Solution For use with the EasyPlus mini EasyMax meter and EasyPlus mini EasyMax Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

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This set of documents describes the FDA's 510(k) clearance for the EasyPlus Mini EasyMax Self-Monitoring Blood Glucose System. However, the provided text does not contain the acceptance criteria or the study details (like sample size, ground truth establishment, expert qualifications, or adjudication methods) that prove the device meets these criteria.

The document is an FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. This letter typically references a submission (the 510(k) premarket notification) that would contain the detailed studies and performance data. This particular document does not include the content of that submission.

Therefore, I cannot provide the requested information based on the given input. To answer your questions, I would need access to the actual 510(k) submission for K082121, which would detail the performance studies and acceptance criteria.

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