Search Results

The StatProfile Ultra A,B,C,D and E Analyzers are intended for in vitro diagnostic use by health care professionals in the quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood.

Intended for Point-of-Care Usage

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called "STAT Profile Ultra A, B, C, D, and E Analyzers". This letter approves the device for marketing based on substantial equivalence to a predicate device, but it does not contain the detailed study results or acceptance criteria for the device's performance.

Therefore, I cannot extract the information required to answer your questions from this document. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical trial report, or the 510(k) submission itself, which would contain the performance data and study details.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• The regulatory classification of the device.
• General regulatory requirements for the manufacturer.
• The intended use of the device: "quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood."
• Mention of "Point-of-Care Usage".

Ask a specific question about this device