Lapas attēli
PDF
ePub

tion procedures in subpart E of part 807 of this chapter. (45 FR 60624, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994)

8864.7525 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]

$ 864.7660 Leukocyte alkaline phos

phatase 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. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 60623, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]

8864.7695 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) $ 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)

[ocr errors]

$ 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. The device is exempt from the premarket notifica

$ 864.7735 Prothrombin-proconvertin

test and thrombotest. (a) Identification. The prothrombinproconvertin test and thrombotest are devices used in the regulation of coumarin therapy (administration of a coumarin anticoagulant such as dium 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)

8864.7750 Prothrombin time test.

(a) Identification. A prothrombin time test is a device used as a general screening procedure for the detection (b) Classification. Class II (performance standards).

[45 FR 60629, Sept. 12, 1980)

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)

$ 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).

Subpart 1-Hematology Reagents 8 864.8100 Bothrops atrox reagent.

(a) Identification. A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen levels to aid in the evaluation of disseminated intravascular coagulation (nonlocalized clotting in the blood vessels) in patients receiving heparin therapy (the administration of the anticoagulant heparin in the treatment of thrombosis) or as an aid in the classification dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen).

(b) Classification. Class II (performance standards). (45 FR 60629, Sept. 12, 1980)

of

(45 FR 60627, Sept. 12, 1980)

$ 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).

$864.8150 Calibrator for cell indices.

(a) Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

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

[45 FR 60628, Sept. 12, 1980)

8 864.7900 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. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 60628, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994)

(45 FR 60631, Sept. 12, 1980)

$ 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.

8 864.8165 Calibrator for hemoglobin

or hematocrit measurement. (a) Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.

(b) Classification. Class II (performance standards). (45 FR 60632, Sept. 12, 1980)

$864.8175 Calibrator for platelet

counting. (a) Identification. A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platelet counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other characteristics have been precisely and accurately determined.

(b) Classification. Class II (performance standards). (45 FR 60633, Sept. 12, 1980)

$864.8540 Red cell lysing reagent.

(a) Identification. A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 60636, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989)

$864.8185 Calibrator for red cell and

white cell counting. (a) Identification. A calibrator for red cell and white cell counting is a device that resembles red or white blood cells and that is used to set instruments intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

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

$ 864.8625 Hematology quality control

mixture. (a) Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

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

[45 FR 60637, Sept. 12, 1980)

[blocks in formation]

and Research of the Food and Drug Administration.

(b) Classification. Class I (general controls). (45 FR 60638, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988]

8 864.9100 Empty container for the col

lection and processing of blood and

blood components. (a) Identification. An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.

(b) Classification. Class II (performance standards). [45 FR 60638, Sept. 12, 1980)

diagnostic use are materials, such as blood group specific substances prepared from nonhuman sources (e.g., pigs, cows, and horses) used to detect, identify, or neutralize antibodies to various human blood group antigens. This generic type of device does not include materials that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 8 864.9. [45 FR 60640, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 63 FR 59225, Nov. 3. 1998]

8 864.9125 Vacuum-assisted blood col

lection system. (a) Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.

(b) Classification. Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $864.9. [45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

$ 864.9175 Automated blood grouping

and antibody test system. (a) Identification. An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

(b) Classification. Class II (performance standards). [45 FR 60641, Sept. 12, 1980]

$ 864.9145 Processing system for fro

zen blood. (a) Identification. A processing system for frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion.

(b) Classification. Class II (performance standards). [45 FR 60639, Sept. 12, 1980)

$ 864.9185 Blood grouping view box.

(a) Identification. A blood grouping view box is a device with a glass or plastic viewing surface, which may be illuminated and heated, that is used to view cell reactions in antigen-antibody testing.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $ 864.9. [45 FR 60641, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000)

8 864.9195 Blood mixing devices and

blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected.

(b) Classification. Class I (general controls). The manual device is exempt

8 864.9160 Blood group substances of

nonhuman origin for in vitro diag.

nostic use. (a) Identification. Blood group substances of nonhuman origin for in vitro

from the premarket notification procedures in subpart E of part 807 of this chapter subject to 864.9. (45 FR 60642, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000)

one or more of the components, and returns the remainder of the blood to the donor. The components obtained are transfused or used to prepare blood products for administration. These devices operate on either a centrifugal separation principle or a filtration principle. The separation bowls of centrifugal blood cell separators may be reusable or disposable.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See $ 864.3. (45 FR 60645, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987)

$864.9205 Blood and plasma warming

device. (a) Nonelectromagnetic blood or plasma warming device—(1) Identification. A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.

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

(b) Electromagnetic blood and plasma warming device-(1) Identification. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.

(2) Classfication. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See $ 864.3. (45 FR 60642, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987) 8864.9225 Cell-freezing apparatus and

reagents for in vitro diagnostic use. (a) Identification. Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $864.9. (45 FR 60643, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000) 8864.9245 Automated blood cell sepa

rator. (a) Identification. An automated blood cell separator is a device that automatically removes whole blood from a donor, separates the blood into components (red blood cells, white blood cells, plasma, and platelets), retains

$864.9275 Blood bank centrifuge for in

vitro diagnostic use. (a) Identification. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 864.9. [45 FR 60645, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000)

$864.9285 Automated cell-washing

centrifuge for immuno-hematology. (a) Identification. An automated cellwashing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.

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

(45 FR 60646, Sept. 12, 1980]

$ 864.9300 Automated Coombs test sys

tems. (a) Identification. An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red cells. The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is also used in crossmatching and in investigating transfusion reactions and drug-induced red cell sensitization.

« iepriekšējāTurpināt »