(142 days)
The Rapidpoint 405 System Co-ox measurement cartridge measures total hemoglobin and hemoglobin fractions and derivatives in arterial, venous and capillary whole blood samples. Hemoglobin fractions and derivatives are listed below: Fractions: tHb, FO2Hb, FCOHb, FMetHb, FHHb
The Rapidpoint 405 system Co-ox measurement cartridge measures the light from the whole blood at several wavelengths. The measurement cartridge detects and quantifies total hemoglobin (fractions and derivatives) and other related quantifies in the sample. Hemoglobin fractions and dervivatives are listed below: tHb, FO2Hb, FCOHb, FMetHb, FHHb
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) Summary for the Bayer Rapidpoint 405 System, primarily focusing on its device description, technological characteristics, and FDA clearance process.
Therefore, I cannot provide a response to your request, as the necessary details are not present in the given text.
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).