(62 days)
Clinical Blood Gas Mixtures are intended for use as calibration gases for research and Blood Gas Analyzers.
Not Found
I am sorry, but the provided text from the FDA 510(k) K993789 letter and associated documents does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.
This document is a notification from the FDA to General Air Service & Supply regarding their "Clinical Blood Gas Mixture." It primarily states that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, subject to general controls.
Specifically, the document does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample size for a test set, data provenance, or ground truth establishment.
- Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
- Stand-alone algorithm performance or training set details.
The letter focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific metrics and methodologies.
§ 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.