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The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Compact Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

The modified test strip is a blood glucose testing product used in conjunction with the ACCU-CHEK® Compact Plus meter.

Through the use of molecular-cloning techniques, Roche has modified the GDH enzyme to improve specificity for glucose; the modified reaction is referred to hereafter as Mut. Q-GDH.

The newly advanced test strip measures blood glucose rapidly and reliably via an electrochemical detection technique. The new version of the test strip employs a disposable dry reagent based on the Mut. Q-GDH method for glucose determination.

When a drop of blood is applied to the test strip first Glucose is oxidized by the enzyme Mut. Q-GDH with simultaneous reduction of the coenzyme. In a second step the coenzyme is reoxidized by the enzyme Mut. Q-GDH with simultaneous reduction of the mediator which finally reduces the indicator chemically to produce the color of heteropolyblue.

I am sorry, but the provided text does not contain the detailed information necessary to complete the table of acceptance criteria and the study that proves the device meets the acceptance criteria. The document states that "Performance testing on the ACCU-CHEK Compact Plus System demonstrated that the device meets the performance requirements for its intended use" and that "The data demonstrates that the test strip is substantially equivalent to the predicate device," but it does not elaborate on what those performance requirements (acceptance criteria) were, nor does it provide details of the study itself such as sample size, data provenance, ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot generate the requested table and accompanying details based on the given input.

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