Glycosylated Hemoglobin Assay
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Food and Drug Administration, HHS § 864.7525 blood as an aid in the diagnosis of car- a patient. Elevated levels of bon monoxide poisoning. This measure- glycosylated hemoglobin indicate un- ment may be made using methods such controlled diabetes in a patient. as spectroscopy, colorimetry, (b) Classification. Class II (perform- spectrophotometry, and gasometry. ance standards). (b) Classification. Class II (perform- 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 ance standards). 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- [45 FR 60621, Sept. 12, 1980] mine the presence and distribution of fetal hemoglobin (hemoglobin F) in red § 864.7500 Whole blood hemoglobin as- cells or to measure the amount of fetal says. hemoglobin present. The assay may be (a) Identification. A whole blood he- used to detect fetal red cells in the ma- moglobin assay is a device consisting ternal circulation or to detect the ele- or reagents, calibrators, controls, or vated levels of fetal hemoglobin exhib- photometric or spectrophotometric in- ited in cases of hemoglobin abnormali- strumentation used to measure the he- ties such as thalassemia (a hereditary 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. may be made by methods such as elec- (b) Classification. Class II (perform- trophoresis, alkali denaturation, col- ance standards). umn chromatography, or radial [45 FR 60622, Sept. 12, 1980] immunodiffusion. (b) Classification. Class II (perform- § 864.7525 Heparin assay. ance standards). (a) Identification. A heparin assay is a [45 FR 60620, Sept. 12, 1980] device used to determine the level of the anticoagulant heparin in the pa- § 864.7470 Glycosylated hemoglobin tient’s circulation. These assays are assay. quantitative clotting time procedures (a) Identification. A glycosylated he- using the effect of heparin on activated moglobin assay is a device used to coagulation factor X (Stuart factor) or measure the glycosylated hemoglobins procedures based on the neutralization (A1a, A1b, and A1c) in a patient’s blood of heparin by protamine sulfate (a pro- by a column chromatographic proce- tein that neutralizes heparin). dure. Measurement of glycosylated he- (b) Classification. Class II (perform- moglobin is used to assess the level of ance standards). control of a patient’s diabetes and to determine the proper insulin dosage for [45 FR 60623, Sept. 12, 1980] 241 VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00251 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR.