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]

§ 864.9275 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).

[45 FR 60645, Sept. 12, 1980]

§ 864.9285 Automated cell-washing centrifuge for immuno-hematology.

(a) Identification. An automated cell-washing centrifuge for immunohematology 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 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 re

866.3250 Erysipelothrix rhusiopathiae serological reagents.

866.3255 Escherichia coli serological reagents.

866.3270 Flavobacterium spp. serological reagents.

866.3280 Francisella tularensis serological reagents.

866.3290 Gonococcal antibody test (GAT). 866.3300 Haemophilus spp. serological reagents.

866.3305 Herpes simplex virus serological reagents.

866.3320 Histoplasma capsulatum serological reagents.

866.3330 Influenza virus serological reagents.

866.3340 Klebsiella spp. serological reagents.

866.3350 Leptospira spp. serological reagents.

866.3355 Listeria spp. serological reagents. 866.3360 Lymphocytic choriomeningitis

virus serological reagents.

866.3370 Mycobacterium tuberculosis im

munofluorescent reagents. 866.3375 Mycoplasma spp. serological reagents.

866.3380 Mumps virus serological reagents. 866.3390 Neisseria spp. direct serological test reagents.

866.3400 Parainfluenza reagents.

Sec. 866.3500 Rickettsia serological reagents. 866.3510 Rubella virus serological reagents. 866.3520 Rubeola (measles) virus serological reagents.

866.3550 Salmonella spp. serological reagents.

866.3600 Schistosoma spp. serological reagents.

866.3630 Serratia spp. serological reagents. 866.3660 Shigella spp. serological reagents. 866.3680 Sporothrix schenckii serological reagents.

866.3700 Staphylococcus aureus serological reagents.

866.3720 Streptococcus spp. exoenzyme reagents.

866.3740 Streptococcus spp. serological reagents.

866.3780 Toxoplasma gondii serological reagents.

866.3820 Treponema pallidum nontreponemal test reagents.

866.3830 Treponema pallidum treponemal test reagents. 866.3850 Trichinella

reagents.

spiralis serological

virus serological

866.5110 Antiparietal antibody immunological test system.

866.5120 Antismooth muscle antibody immunological test system.

test system.

866.5360 Cohn fraction IV immunological test system.

866.5370 Cohn fraction V immunological test system.

866.5380 Free secretory component immunological test system.

866.5400 Alpha-globulin immunological test system.

866.5420 Alpha-1-glycoproteins immunological test system.

866.5425 Alpha-2-glycoproteins immunological test system.

866.5430 Beta-2-glycoprotein I immunological test system.

866.5440 Beta-2-glycoprotein III immunological test system.

866.5460 Haptoglobin immunological test system.

866.5470 Hemoglobin immunological test system.

866.5490 Hemopexin immunological test system.

866.5500 Hypersensitivity pneumonitis immunological test system.

866.5510 Immunoglobulins A, G, M, D, and E immunological test system. 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system. 866.5530 Immunoglobulin G (Fc fragment specific) immunological test system. 866.5540 Immunoglobulin G (Fd fragment specific) immunological test system.

Subpart A-General Provisions

§ 866.1 Scope.

(a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution.

a

(b) The indentification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for 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]

§ 866.3 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 in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

(c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(1) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional device states that as of the enactment date of the