(64 days)
The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in samples of whole blood, serum, and plasma in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, PO2, sodium and potassium of whole blood, plasma or serum as appropriate. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 7 tests on a single sample, determined by the type of disposable cassette used.
The AVL OPTI Critical Care Analyzer is a medical device intended for measuring pH, PCO2, PO2, sodium, potassium, total hemoglobin content, and oxygen saturation in blood, serum, and plasma samples. The device uses optical fluorescence for some measurements and optical reflectance for others.
Here's a breakdown of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: **"In all evaluations, there was no significant difference in mean values ( P
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.