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The Stat Profile pHOx Basic Analyzer is intended for in vitro diagnostic use by health care professionals in the measurement of pH, pCO2 and pO2 in heparinized whole blood. Measurements of blood gases and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

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This document is a 510(k) premarket notification from the FDA, specifically a letter determining substantial equivalence. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive submission document.

Therefore, I cannot provide the requested information based solely on the provided text. The document states "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the FDA found the device (Stat Profile pHOx Basic Analyzer) equivalent to existing devices, but the letter itself does not include the performance data of the new device or the details of the studies conducted to establish that equivalence.

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