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The BTg Smartest Glucose test system is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

A chemical reaction between glucose in whole blood and the chemicals on the test strip produce a current. The meter measures the current and the meter calculates glucose concentrations from the current produced in the reaction.

The provided text does not contain information about the acceptance criteria, a study proving the device meets the acceptance criteria, or any of the specific details requested in the bullet points (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, sample size for training set, or how training set ground truth was established).

The document is a 510(k) summary and clearance letter for the BTg Smartest Glucose Test System. It focuses on establishing substantial equivalence to a predicate device (Bayer Elite) based on intended use, technology, and measuring range, rather than presenting detailed performance study results against specific acceptance criteria.

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