(23 days)
The Stat profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of pH, PCO2, PO2, oxygen saturation (SO2%), hematocrit (Hct), and Hemoglobin (Hb) in heparinized whole blood and pCO2 and PO2 in expired (exhaled) gases.
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This document is a 510(k) clearance letter from the FDA for a blood gas analyzer. It does not contain the kind of detailed information requested about acceptance criteria and a study proving a device meets those criteria. The letter primarily states that the device is substantially equivalent to previously marketed devices and can therefore be marketed.
Therefore, I cannot extract the requested information from the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- How training set ground truth was established.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.