(22 days)
The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
The Omni C analyzer represents a combined blood gas, electrolyte, total hemoglobin, hematocrit and oxygen saturation test system classified as a Class II device under various sections of 21 CFR 862 and 864 based on the individual test parameters measured.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Omni C Analyzer, focusing on its substantial equivalence to a predicate device. It describes the device's intended use, its similarities and differences to the predicate, and lists the regulatory classifications, but it does not include details on performance studies, sample sizes, expert involvement, or ground truth establishment.
§ 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.