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Medisign MM1000 Blood Glucose Monitoring System, MM1100 Blood Glucose Monitoring System, and Medisign MM1200 Blood Glucose Monitoring System are intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for selftesting by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in the systems can only be used during steady-state blood glucose conditions.

The Medisign™ MM1000 test strip is to be used with Medisign™ MM1000 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1100 test strip is to be used with Medisign™ MM1100 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1200 test strip is to be used with Medisign™ MM1200 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign MM1000 Multi Blood Glucose Monitoring System, Medisign MM1100 Multi Blood Glucose Monitoring System, and Medisign MM1200 Multi Blood Glucose Monitoring System are intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in clinical settings. It is intended for use outside of the body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in the systems can only be used during steady-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system.

The Medisign™ MM1000 Multi Blood Glucose Test strip is to be used with Medisign™ MM1000 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing, The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1100 Multi Blood Glucose Test strip is to be used with Medisign™ MM1100 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing. The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1200 Multi Blood Glucose Test strip is to be used with Medisign™ MM1200 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing. The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign™ Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign™ Test Strips to check that the meter and test strips are working together properly. Medisign™ Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign™ Glucose Control Solutions are for in vitro diagnostic use.

Medisign MM1000 Blood Glucose Monitoring System, MM1100 Blood Glucose Monitoring System, and Medisign MM1200 Blood Glucose Monitoring System are basically provided with a blood glucose meter, blood glucose test strips (10T), and a carrying bag including user manual, quick reference manual and log book. Blood glucose test strips (25T, 50T), blood glucose control solutions (Level A, Level B), check strip, diabetes management software, and data transporting cable are sold separately.

Medisign MM1000 Multi Blood Glucose Monitoring System, Medisign MM1100 Multi Blood Glucose Monitoring System, and Medisign MM1200 Multi Blood Glucose Monitoring System are basically provided with a blood glucose meter, blood glucose test strips (107), and a carrying bag including user manual, quick reference manual and log book. Disposable lancing device, blood glucose test strips (25T, 50T), blood glucose control solutions (Level A, Level B), check strip, diabetes management software, and data transporting cable are sold separately.

Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) - 2.5 units, redox mediator - 32.3µg and buffer & non-reactant - 50.5µg.

Each box of control solutions (Level A and Level B) contains one vial of aqueous control solution (4ml each): Level A contains 0.11% concentrations of glucose (approximately 120 mg/dL) and Level B contains 0.23% concentrations of glucose (approximately 320 mg/dL).

Only the difference among six blood glucose monitoring systems above is the appearance of the top cases of the meters. Six blood glucose monitoring systems use the same PCB, the same LCD, the same Software, the same test strip, and the same control solution.

This is a 510(k) premarket notification for Medisign MM1000, MM1100, and MM1200 Blood Glucose Monitoring Systems, and their "Multi" versions. The document states that "clinical data demonstrate the performance of the subject devices well with the laboratory glucose reference test equipment. All predetermined acceptance criteria were satisfied." However, the document does not provide specific acceptance criteria or detailed study results.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document only states that "All predetermined acceptance criteria were satisfied" and the "clinical data demonstrate the performance of the subject devices well with the laboratory glucose reference test equipment." This is a general statement and lacks the specificity required to answer your questions.

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