Section 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).45 FR 60601, Sept. 12, 1980