StatStrip Glucose/Ketone Meter System Ketone Evaluation

The primary objectives of this study are:

• To assess the performance of the StatStrip Ketone assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method.
• To assess the Ease of Use of the StatStrip Glucose / Ketone Meter System in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package-insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the CLIA-Waived POC Users other than clarifying the protocol.

Inclusion criteria

• Adult subjects (≥ 18 years old) with diabetes or suspected ketonemia.
• Adult subjects (≥ 18 years old) that are healthy.
• Subjects willing and able to consent to participating in the study.
• Subjects whose pre-screen ketone value, if performed, is deemed valuable to the study.

Exclusion criteria

• Subjects unable to consent to participating in the study.
• Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.