Food and Drug Administration, HHS § 864.7490

§ 864.7400 Hemoglobin A2 assay. § 864.7455 Fetal hemoglobin assay.

(a) Identification. A hemoglobin A2 (a) Identification. A fetal hemoglobin assay is a device used to determine the assay is a device that is used to deter- hemoglobin A2 content of human blood. mine the presence and distribution of The measurement of hemoglobin A2 is fetal hemoglobin (hemoglobin F) in red used in the diagnosis of the cells or to measure the amount of fetal thalassemias (hereditary hemolytic hemoglobin present. The assay may be anemias characterized by decreased used to detect fetal red cells in the ma- synthesis of one or more types of he- ternal circulation or to detect the ele- moglobin polypeptide chains). vated levels of fetal hemoglobin exhib- (b) Classification. Class II (perform- ited in cases of hemoglobin abnormali- ties such as thalassemia (a hereditary ance standards). hemolytic anemia characterized by a [45 FR 60617, Sept. 12, 1980] decreased synthesis of one or more types of hemoglobin polypeptide § 864.7415 Abnormal hemoglobin assay. chains). The hemoglobin determination (a) Identification. An abnormal hemo- may be made by methods such as elec- globin assay is a device consisting of trophoresis, alkali denaturation, col- the reagents, apparatus, instrumenta- umn chromatography, or radial tion, and controls necessary to isolate immunodiffusion. and identify abnormal genetically de- (b) Classification. Class II (perform- termined hemoglobin types. ance standards). (b) Classification. Class II (perform- [45 FR 60620, Sept. 12, 1980] ance standards). § 864.7470 Glycosylated hemoglobin [45 FR 60618, Sept. 12, 1980] assay. § 864.7425 Carboxyhemoglobin assay. (a) Identification. A glycosylated hemoglobin 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 (a) Identification. A sulfhemoglobin analysis system. 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 blood as an aid in the diagnosis of of anemia or erythrocytosis (increased sulfhemoglobinemia (presence of total red cell mass) due to a hemo- sulfhemoglobin in the blood due to globin abnormality. drug administration or exposure to a (b) Classification. Class II (perform- poison). This measurement may be made using methods such as spectros- ance standards). copy, colorimetry, spectrophotometry, [45 FR 60620, Sept. 12, 1980] or gasometry.

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