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The SURESTEP®PRO and the SURESTEPFLEXX Professional Blood Glucose Management Systems are for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. These systems can also be used by lay users at home.

The SURESTEPPRO and SURESTEPFLEXX Systems consist of a rest strip (SURESTEPPRO Test Strips), a reflectance photometer, quality control solutions, and linearity solutions. Ancillary devices to aid in obtaining blood samples (e.g. lancing devices) and external data management computer software designed to facilitate storage and retrieval of results are also provided.

A sample is placed on a test strip and inserted into the reflectance photometer. Glucose in the sample reacts with oxygen in a glucose oxidase catalyzed reaction yielding gluconic acid and hydrogen peroxide. A second enzyme, peroxidase, mediates transformation of indicator dyes into products with a blue color. The intensity of the resulting blue color is proportional to the concentration of glucose in the sample. The meter measures the amount of light reflected by this blue colored product and converts the reflectance data into a glucose concentration that is displayed on a liquid crystal display. The user adjusts the meter response for each lot of test strips by entering a calibration code specific to that lot of rest strips.

This 510(k) summary does not contain the information requested to describe acceptance criteria and a study proving a device meets these criteria. It primarily focuses on comparing the SURESTEP®PRO and SURESTEP®FLEXX Professional Blood Glucose Management Systems to a predicate device for substantial equivalence, specifically mentioning simplification of labeling for better understanding of performance capabilities and limitations.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions.

The document states: "The modified SURESTEPRO Professional Blood Glucose Management System and the SURESTEPFLEXX Professional Blood Glucose Management System is substantially equivalent to the predicate device." This indicates the submission aimed to show similarity to an already approved device, rather than providing detailed performance data against new acceptance criteria for the modified devices.

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