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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR864]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 864HEMATOLOGY AND PATHOLOGY DEVICES
 

Subpart H--Hematology Kits and Packages

Sec. 864.7040 Adenosine triphosphate release assay.

(a) Identification. An adenosine triphosphate release assay is a device that measures the release of adenosine triphosphate (ATP) from platelets following aggregation. This measurement is made on platelet-rich plasma using a photometer and a luminescent firefly extract. Simultaneous measurements of platelet aggregation and ATP release are used to evaluate platelet function disorders.

(b) Classification. Class I (general controls).

[45 FR 60609, Sept. 12, 1980]

Sec. 864.7060 Antithrombin III assay.

(a)Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

(b)Classification. Class II (performance standards).

[45 FR 60609, Sept. 12, 1980]

Sec. 864.7100 Red blood cell enzyme assay.

(a)Identification. Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.

(b)Classification. Class II (performance standards).

[45 FR 60610, Sept. 12, 1980]

Sec. 864.7140 Activated whole blood clotting time tests.

(a)Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

(b)Classification. Class II (performance standards).

[45 FR 60611, Sept. 12, 1980]

Sec. 864.7250 Erythropoietin assay.

(a)Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.

(b)Classification. Class II. The special control for this device is FDA's "Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s)."

[45 FR 60612, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, 2000]

Sec. 864.7275 Euglobulin lysis time tests.

(a)Identification. A euglobulin lysis time test is a device that measures the length of time required for the lysis (dissolution) of a clot formed from fibrinogen in the euglobulin fraction (that fraction of the plasma responsible for the formation of plasmin, a clot lysing enzyme). This test evaluates natural fibrinolysis (destruction of a blood clot after bleeding has been arrested). The test also will detect accelerated fibrinolysis.

(b)Classification. Class II (performance standards).

[45 FR 60612, Sept. 12, 1980]

Sec. 864.7280 Factor V Leiden DNA mutation detection systems.

(a)Identification. Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.

(b)Classification. Class II (special controls). The special control is FDA's guidance entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." (See 864.1(d) for the availability of this guidance document.)

[69 FR 12273, Mar. 16, 2004]

Sec. 864.7290 Factor deficiency test.

(a)Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).

(b)Classification. Class II (performance standards).

[45 FR 60613, Sept. 12, 1980]

Sec. 864.7300 Fibrin monomer paracoagulation test.

(a)Identification. A fibrin monomer paracoagulation test is a device used to detect fibrin monomer in the diagnosis of disseminated intravascular coagulation (nonlocalized clotting within a blood vessel) or in the differential diagnosis between disseminated intravascular coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot).

(b)Classification. Class II. The special control for this device is FDA's "In Vitro Diagnostic Fibrin Monomer Paracoagulation Test."

[45 FR 60614, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, 2000]

Sec. 864.7320 Fibrinogen/fibrin degradation products assay.

(a)Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).

(b)Classification. Class II (performance standards).

[45 FR 60615, Sept. 12, 1980]

Sec. 864.7340 Fibrinogen determination system.

(a)Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

(b)Classification. Class II (performance standards).

[45 FR 60615, Sept. 12, 1980]

Sec. 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.

(a)Identification. An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.

(b)Classification. Class II (performance standards).

[45 FR 60616, Sept. 12, 1980]

Sec. 864.7375 Glutathione reductase assay.

(a)Identification. A glutathione reductase assay is a device used to determine the activity of the enzyme glutathione reductase in serum, plasma, or erythrocytes by such techniques as fluorescence and photometry. The results of this assay are used in the diagnosis of liver disease, glutathione reductase deficiency, or riboflavin deficiency.

(b)Classification. Class II (performance standards).

[45 FR 60616, Sept. 12, 1980]

Sec. 864.7400 Hemoglobin A2assay.

(a)Identification. A hemoglobin A2assay is a device used to determine the hemoglobin A2content of human blood. The measurement of hemoglobin A2is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).

(b)Classification. Class II (performance standards).

[45 FR 60617, Sept. 12, 1980]

Sec. 864.7415 Abnormal hemoglobin assay.

(a)Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.

(b)Classification. Class II (performance standards).

[45 FR 60618, Sept. 12, 1980]

Sec. 864.7425 Carboxyhemoglobin assay.

(a)Identification. A carboxyhemoglobin assay is a device used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry.

(b)Classification. Class II (performance standards).

[45 FR 60619, Sept. 12, 1980]

Sec. 864.7440 Electrophoretic hemoglobin analysis system.

(a)Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.

(b)Classification. Class II (performance standards).

[45 FR 60620, Sept. 12, 1980]

Sec. 864.7455 Fetal hemoglobin assay.

(a)Identification. A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cells in the maternal circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial immunodiffusion.

(b)Classification. Class II (performance standards).

[45 FR 60620, Sept. 12, 1980]

Sec. 864.7470 Glycosylated hemoglobin assay.

(a)Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

(b)Classification. Class II (performance standards).

[45 FR 60621, Sept. 12, 1980]

Sec. 864.7490 Sulfhemoglobin assay.

(a)Identification. A sulfhemoglobin assay is a device consisting of the reagents, calibrators, controls, and instrumentation used to determine the sulfhemoglobin (a compound of sulfur and hemoglobin) content of human blood as an aid in the diagnosis of sulfhemoglobinemia (presence of sulfhemoglobin in the blood due to drug administration or exposure to a poison). This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, or gasometry.

(b)Classification. Class II (performance standards).

[45 FR 60621, Sept. 12, 1980]

Sec. 864.7500 Whole blood hemoglobin assays.

(a)Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

(b)Classification. Class II (performance standards).

[45 FR 60622, Sept. 12, 1980]

Sec. 864.7525 Heparin assay.

(a)Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

(b)Classification. Class II (performance standards).

[45 FR 60623, Sept. 12, 1980]

Sec. 864.7660 Leukocyte alkaline phosphatase test.

(a)Identification. A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in neutrophilic granulocytes (granular leukocytes stainable by neutral dyes). The cytochemical identification of alkaline phosphatase depends on the formation of blue granules in cells containing alkaline phosphatase. The results of this test are used to differentiate chronic granulocytic leukemia (a malignant disease characterized by excessive overgrowth of granulocytes in the bone marrow) and reactions that resemble true leukemia, such as those occuring in severe infections and polycythemia (increased total red cell mass).

(b)Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

[45 FR 60623, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, 2001]

Sec. 864.7675 Leukocyte peroxidase test.

(a)Identification. A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.

(b)Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

[45 FR 60624, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, 2001]

Sec. 864.7695 Platelet factor 4 radioimmunoassay.

(a)Identification. A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.

(b)Classification. Class II (performance standards).

[45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. 3, 1981]

Sec. 864.7720 Prothrombin consumption test.

(a)Identification. A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B.

(b)Classification. Class II (performance standards).

[45 FR 60625, Sept. 12, 1980]

Sec. 864.7735 Prothrombin-proconvertin test and thrombotest.

(a)Identification. The prothrombin-proconvertin test and thrombotest are devices used in the regulation of coumarin therapy (administration of a coumarin anticoagulant such as sodium warfarin in the treatment of venous thrombosis and pulmonary embolism) and as a diagnostic test in conjunction with, or in place of, the Quick prothrombin time test to detect coagulation disorders.

(b)Classification. Class II (performance standards).

[45 FR 60626, Sept. 12, 1980]

Sec. 864.7750 Prothrombin time test.

(a)Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

(b)Classification. Class II (performance standards).

[45 FR 60626, Sept. 12, 1980]

Sec. 864.7825 Sickle cell test.

(a)Identification. A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.

(b)Classification. Class II (performance standards).

[45 FR 60627, Sept. 12, 1980]

Sec. 864.7875 Thrombin time test.

(a)Identification. A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.

(b)Classification. Class II (performance standards).

[45 FR 60628, Sept. 12, 1980]

Sec. 864.7900 Thromboplastin generation test.

(a)Identification. A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.

(b)Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

[45 FR 60628, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, 2001]

Sec. 864.7925 Partial thromboplastin time tests.

(a)Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

(b)Classification. Class II (performance standards).

[45 FR 60629, Sept. 12, 1980]

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

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