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]

$864.9225 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 separator.

(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. 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]

§864.9300 Automated Coombs test systems.

(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]

§864.9320 Copper sulfate solution for specific gravity determinations.

(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]

§864.9400 Stabilized enzyme solution.

(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]

$864.9550 Lectins and protectins.

(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]

$864.9575 Environmental chamber for storage of platelet concentrate.

(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]

§864.9600 Potentiating media for in vitro diagnostic use.

(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]

$864.9650 Quality control kit for blood banking reagents.

(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]

§864.9700 Blood storage refrigerator and blood storage freezer.

(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]

§864.9750 Heat-sealing device.

(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]

§864.9875 Transfer set.

(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.

manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by §807.87.

(c) To avoid duplicative listings, an immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device and as a microbiology device) is listed only in one subpart.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

[52 FR 17733, May 11, 1987]

8866.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III (Premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraphs (b) and (c) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown