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The GluNEO™ Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Glubert Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The GluNEO™ Lite Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It 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 GluNEO™ Lite Test Strips are for use with the GluNEO™ Lite Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The GluNEO™ Lite Control Solutions are for use with the GluNEO™ Lite Meter and GluNEO™ Lite Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The GluNEO™ Lite Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Lite Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, singleuse lancing devices. The GluNEO™ Lite Professional 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 GluNEO™ Lite Professional Test Strips are for use with the GluNEO™ Lite Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips. ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The GluNEO™ Lite Professional Control Solutions are for use with the GluNEO™ Lite Professional Meter and GluNEOTM Lite Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System consists of a meter, test strips and control solutions (level 2 and level 3), a lancing device and sterile lancets. With the GluNEOTM Lite Professional Blood Glucose Monitoring System, only auto-disabling or single use lancing device must be used. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to meeting the requirements of ISO 15197:2003 for performance. While the specific numerical acceptance criteria from ISO 15197:2003 are not explicitly listed in the summary, they are a well-established international standard for blood glucose monitoring systems. For the purpose of this response, I will state the criteria as per ISO 15197:2003 and then interpret the "reported device performance" based on the general statement in the document that the device "passed all of the tests based on pre-determined Pass/Fail criteria."

Implicit Acceptance Criteria (based on ISO 15197:2003 for glucose meters) and Reported Device Performance:

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