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| [Code of Federal Regulations] |
| [Title 21, Volume 8] |
| [CITE: 21CFR864] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
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| PART 864 | HEMATOLOGY AND PATHOLOGY DEVICES |
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Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products
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Sec. 864.9050 Blood bank supplies.
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(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]
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Sec. 864.9100 Empty container for the collection and processing of blood and blood components.
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(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]
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Sec. 864.9115 Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
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(a) Identification. A container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) The intended use of the device must specify:
(i) The Red Blood Cell components that can be processed and stored including acceptable anticoagulants and additive solutions;
(ii) The hold time after Red Blood Cell component collection;
(iii) The processing capacity (volume) of the device; and
(iv) The storage temperature and dating period of processed Red Blood Cell components.
(2) Studies must demonstrate that the device is biocompatible and include detailed documentation of the biocompatibility evaluation.
(3) Performance testing and nonclinical studies must include a detailed study of leached materials extracted under conditions similar to clinical usage of the device, and a toxicologic risk assessment of those extracted or leached materials.
(4) Performance testing must support sterility of the device and include sterilization validation, endotoxin testing, and container closure integrity evaluation.
(5) Nonclinical and clinical studies must include evaluation of red blood cell quality throughout the duration of storage based on in vitro and in vivo studies, including hemolysis and red blood cell survival and recovery.
(6) Performance studies must include:
(i) Detailed documentation of functional and mechanical testing, including evaluation of oxygen and, if applicable, carbon dioxide levels during Red Blood Cell components storage; and
(ii) Detailed documentation of device shelf-life testing demonstrating continued sterility, package integrity, and functionality over the identified shelf life.
(7) The labeling must include a contraindication against processing Red Blood Cell components collected from donors with hemoglobin S.
[88 FR 77199, Nov. 9, 2023]
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Sec. 864.9125 Vacuum-assisted blood collection system.
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(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]
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Sec. 864.9145 Processing system for frozen blood.
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(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]
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Sec. 864.9160 Blood group substances of nonhuman origin for in vitro diagnostic use.
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(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]
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Sec. 864.9165 Blood establishment computer software and accessories.
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(a) Identification. Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. This generic type of device may include a BECS accessory, a device intended for use with BECS to augment the performance of the BECS or to expand or modify its indications for use.
(b) Classification. Class II (special controls). The special controls for these devices are:
(1) Software performance and functional requirements including detailed design specifications (e.g., algorithms or control characteristics, alarms, device limitations, and safety requirements).
(2) Verification and validation testing and hazard analysis must be performed.
(3) Labeling must include:
(i) Software limitations;
(ii) Unresolved anomalies, annotated with an explanation of the impact on safety or effectiveness;
(iii) Revision history; and
(iv) Hardware and peripheral specifications.
(4) Traceability matrix must be performed.
(5) Performance testing to ensure the safety and effectiveness of the system must be performed, including when adding new functional requirements (e.g., electrical safety, electromagnetic compatibility, or wireless coexistence).
[83 FR 23217, June 18, 2018]
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Sec. 864.9175 Automated blood grouping and antibody test system.
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(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]
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Sec. 864.9185 Blood grouping view box.
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(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]
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Sec. 864.9195 Blood mixing devices and blood weighing devices.
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(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]
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Sec. 864.9205 Blood and plasma warming device.
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(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]
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Sec. 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.
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(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]
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Sec. 864.9245 Automated blood cell separator.
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(a) Identification. An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.
(b) Classification. Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled "Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle."
[72 FR 67644, Nov. 30, 2007]
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Sec. 864.9275 Blood bank centrifuge for in vitro diagnostic use.
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(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]
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Sec. 864.9285 Automated cell-washing centrifuge for immuno-hematology.
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(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]
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Sec. 864.9300 Automated Coombs test systems.
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(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]
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Sec. 864.9320 Copper sulfate solution for specific gravity determinations.
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(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]
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Sec. 864.9400 Stabilized enzyme solution.
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(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 (special controls). The 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 60647, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]
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Sec. 864.9550 Lectins and protectins.
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(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]
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Sec. 864.9575 Environmental chamber for storage of platelet concentrate.
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(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]
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Sec. 864.9600 Potentiating media for in vitro diagnostic use.
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(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]
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Sec. 864.9650 Quality control kit for blood banking reagents.
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(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]
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Sec. 864.9700 Blood storage refrigerator and blood storage freezer.
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(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]
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Sec. 864.9750 Heat-sealing device.
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(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]
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Sec. 864.9875 Transfer set.
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(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]
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Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
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