§ 864.7415 21 CFR Ch. I (4–1–13 Edition)

§ 864.7415 Abnormal hemoglobin assay. may be made by methods such as elec- (a) Identification. An abnormal hemo- trophoresis, alkali denaturation, col- globin assay is a device consisting of umn chromatography, or radial the reagents, apparatus, instrumenta- immunodiffusion. tion, and controls necessary to isolate (b) Classification. Class II (perform- and identify abnormal genetically de- ance standards). termined hemoglobin types. [45 FR 60620, Sept. 12, 1980] (b) Classification. Class II (perform- ance standards). § 864.7470 Glycosylated hemoglobin [45 FR 60618, Sept. 12, 1980] assay. (a) Identification. A glycosylated he- § 864.7425 Carboxyhemoglobin assay. moglobin assay is a device used to (a) Identification. A measure the glycosylated hemoglobins carboxyhemoglobin assay is a device (A1a, A1b, and A1c) in a patient’s blood used to determine the by a column chromatographic proce- carboxyhemoglobin (the compound dure. Measurement of glycosylated he- formed when hemoglobin is exposed to moglobin is used to assess the level of carbon monoxide) content of human control of a patient’s diabetes and to blood as an aid in the diagnosis of car- determine the proper insulin dosage for bon monoxide poisoning. This measure- a patient. Elevated levels of ment may be made using methods such glycosylated hemoglobin indicate un- as spectroscopy, colorimetry, controlled diabetes in a patient. spectrophotometry, and gasometry. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). [45 FR 60621, Sept. 12, 1980] [45 FR 60619, Sept. 12, 1980] § 864.7490 Sulfhemoglobin assay. § 864.7440 Electrophoretic hemoglobin analysis system. (a) Identification. A sulfhemoglobin assay is a device consisting of the re- (a) Identification. An electrophoretic agents, calibrators, controls, and in- hemoglobin analysis system is a device strumentation used to determine the that electrophoretically separates and sulfhemoglobin (a compound of sulfur identifies normal and abnormal hemo- and hemoglobin) content of human globin types as an aid in the diagnosis of anemia or erythrocytosis (increased blood as an aid in the diagnosis of total red cell mass) due to a hemo- sulfhemoglobinemia (presence of globin abnormality. sulfhemoglobin in the blood due to (b) Classification. Class II (perform- drug administration or exposure to a ance standards). poison). This measurement may be made using methods such as spectros- [45 FR 60620, Sept. 12, 1980] copy, colorimetry, spectrophotometry, or gasometry. § 864.7455 Fetal hemoglobin assay. (b) Classification. Class II (perform- (a) Identification. A fetal hemoglobin ance standards). assay is a device that is used to deter- mine the presence and distribution of [45 FR 60621, Sept. 12, 1980] fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal § 864.7500 Whole blood hemoglobin as- says. hemoglobin present. The assay may be used to detect fetal red cells in the ma- (a) Identification. A whole blood he- ternal circulation or to detect the ele- moglobin assay is a device consisting vated levels of fetal hemoglobin exhib- or reagents, calibrators, controls, or ited in cases of hemoglobin abnormali- photometric or spectrophotometric in- ties such as thalassemia (a hereditary strumentation used to measure the he- hemolytic anemia characterized by a moglobin content of whole blood for decreased synthesis of one or more the detection of anemia. This generic types of hemoglobin polypeptide device category does not include auto- chains). The hemoglobin determination mated hemoglobin systems.

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