21 C.F.R. Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
Title 21 - Food and Drugs
(a) Identification. Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation 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] (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] (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] (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] (a) Identification. Blood group substances of nonhuman origin for in vitro 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 §864.9. [45 FR 60640, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 63 FR 59225, Nov. 3, 1998] (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] (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] (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 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] (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] (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] (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 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 of device operating by filtration separation principle. Class II (special controls). The special controls for the device are that the manufacturer must file an annual report with FDA for 3 consecutive years. Each annual report must include the following: (1) A summary of adverse donor reactions reported by the users to the manufacturer that do not meet the threshold for medical device reporting under part 803 of this chapter; (2) Any change to the device, including but not limited to: (i) New indications for use of the device; (ii) Labeling changes, including operation manual changes; (iii) Computer software changes, hardware changes, and disposable item changes, e.g., collection bags, tubing, filters; (3) Equipment failures, including software, hardware, and disposable item failures, e.g., collection bags, tubing, filters. (c) Classification of device operating by centrifugal separation principle. Class III (premarket approval). (d) 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 (c) of this section. See §864.3. [45 FR 60645, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 68 FR 9532, Feb. 28, 2003] (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] (a) Identification. An automated cell-washing 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] (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. (b) Classification. Class II (performance standards). [45 FR 60646, Sept. 12, 1980] (a) Identification. A copper sulfate solution for specific gravity determinations is a device used to determine whether the hemoglobin content of a potential donor's blood meets the required level (12.5 grams per 100 milliliters of blood for women and 13.5 grams per 100 milliliters of blood for men). (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 60647, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000] (a) Identification. A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of red blood cells with certain antibodies, including antibodies that are not detectable by other techniques. These enzyme solutions include papain, bromelin, ficin, and trypsin. (b) Classification. Class II (performance standards). [45 FR 60647, Sept. 12, 1980] (a) Identification. Lectins and protectins are proteins derived from plants and lower animals that cause cell agglutination in the presence of certain antigens. These substances are used to detect blood group antigens for in vitro diagnostic purposes. (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 §864.9. [45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998] (a) Identification. An environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range. (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 §864.9. [45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998] (a) Identification. Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing. (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 §864.9. [45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998] (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking. (b) Classification. Class II (performance standards). [45 FR 60649, Sept. 12, 1980] (a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures. (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 §864.9. [45 FR 60650, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998] (a) Identification. A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components. (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 60650, Sept. 12, 1980, as amended at 65 FR 2311, Jan. 14, 2000] (a) Identification. A transfer set is a device intended for medical purposes that consists of a piece of tubing with suitable adaptors used to transfer blood or plasma from one container to another. (b) Classification. Class II (performance standards). [45 FR 60651, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
§ 864.9050 Blood bank supplies.
§ 864.9100 Empty container for the collection and processing of blood and blood components.
§ 864.9125 Vacuum-assisted blood collection system.
§ 864.9145 Processing system for frozen blood.
§ 864.9160 Blood group substances of nonhuman origin for in vitro diagnostic use.
§ 864.9175 Automated blood grouping and antibody test system.
§ 864.9185 Blood grouping view box.
§ 864.9195 Blood mixing devices and blood weighing devices.
§ 864.9205 Blood and plasma warming device.
§ 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.
§ 864.9245 Automated blood cell separator.
§ 864.9275 Blood bank centrifuge for in vitro diagnostic use.
§ 864.9285 Automated cell-washing centrifuge for immuno-hematology.
§ 864.9300 Automated Coombs test systems.
§ 864.9320 Copper sulfate solution for specific gravity determinations.
§ 864.9400 Stabilized enzyme solution.
§ 864.9550 Lectins and protectins.
§ 864.9575 Environmental chamber for storage of platelet concentrate.
§ 864.9600 Potentiating media for in vitro diagnostic use.
§ 864.9650 Quality control kit for blood banking reagents.
§ 864.9700 Blood storage refrigerator and blood storage freezer.
§ 864.9750 Heat-sealing device.
§ 864.9875 Transfer set.
