Search Results

The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage in the quantitative determination of sodium, potassium, chloride, ionized calcium, creatinine, glucose, lactate, and BUN in serum, plasma and whole blood.; of pH, PCO2, PO2, oxygen saturation, hematocrit and hemoglobin in whole blood.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Stat Profile M 7 Analyzer" (later referred to as "Stat Profile Ultra M7 Analyzer"). It does not contain the detailed technical specifications, acceptance criteria, or study results that would typically describe the device's performance against specific metrics.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the provided text.

The document primarily focuses on:

• Confirming substantial equivalence to a predicate device.
• Outlining regulatory requirements and controls.
• Stating the intended use and analytes the device measures.

To answer your questions, one would need to review the original 510(k) submission (K991727) or other technical documentation provided by Nova Biomedical for the Stat Profile Ultra M7 Analyzer.

Ask a specific question about this device