diowaves 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).

[45 FR 60643, Sept. 12, 1980]

§ 864.9245 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]

§ 864.9275 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 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).

[45 FR 60647, Sept. 12, 1980]

§ 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 b other techniques. These enzyme so

§ 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 (performance standards).

[45 FR 60650, Sept. 12, 1980]

§ 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).

[45 FR 60650, Sept. 12, 1980]

Subpart D-Serological Reagents

866.3010 Acinetobacter calcoaceticus serological reagents.

866.3020 Adenovirus serological reagents. 866.3035 Arizona spp. serological reagents. 866.3040 Aspergillus spp. serological reagents.

866.3060 Blastomyces dermatitidis serological reagents.

866.3065 Bordetella spp. serological reagents.

866.3085 Brucella spp. serological reagents. 866.3110 Campylobacter fetus serological reagents.

866.3120 Chlamydia serological reagents. 866.3125 Citrobacter spp. serological reagents.

866.3135 Coccidioides immitis serological reagents.

866.3140 Corynebacterium spp. serological reagents.

866.3145 Coxsackievirus serological reagents.

866.3165 Cryptococcus neoformans serological reagents.

866.3175 Cytomegalovirus serological reagents.

866.3200 Echinococcus spp. serological reagents.

866.3205 Echovirus serological reagents. 866.3220 Entamoeba histolytica serological reagents.

866.3235 Epstein-Barr virus serological reagents.

866.3240 Equine encephalomyelitis virus serological reagents.

866.3250 Erysipelothrix rhusiopathiae serological reagents.

866.3255 Escherichia coli serological rea

gents.

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 vírus 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 virus serological reagents.

866.3405 Poliovirus serological reagents. 866.3410 Proteus spp. (Weil-Felix) serological reagents.

866.3415 Pseudomonas spp. serological reagents.

866.3460 Rabiesvirus reagents.

immunofluorescent

866.3470 Reovirus serological reagents. 866.3480 Respiratory syncytial virus serological reagents.

866.3490 Rhinovirus serological reagents. 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

866.5320 Properidin factor B immunological test system.

866.5330 Factor XIII, A, S, immunological test system. 866.5340 Ferritin system.

immunological

test

866.5350 Fibrinopeptide A immunological 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. 866.5550 Immunoglobulin (light chain specific) immunological test system. 866.5560 Lactic dehydrogenase immunological test system.

866.5570 Lactoferrin immunological test system.

866.5580 Alpha-1-lipoprotein immunological test system.

866.5590 Lipoprotein X immunological test system.

866.5600 Low-density lipoprotein immunological test system.

866.5620 Alpha-2-macroglobulin immunological test system.

866.5630 Beta-2-microglobulin immunological test system.

866.5640 Infectious mononucleosis immunological test system.

866.5660 Multiple autoantibodies immunological test system.

866.5680 Myoglobin

system.

immunological

test

866.5735 Prothrombin immunological test system.

866.5750 Radioallergosorbent (RAST) immunological test system.

866.5765 Retinol-binding protein immunological test system.

866.5775 Rheumatoid factor immunological test system.

866.5800 Seminal fluid (sperm) immunological test system.

866.5820 Systemic lupus erythematosus immunological test system.

866.5860 Total spinal fluid immunological test system.

866.5870 Thyroid autoantibody immunological test system.

866.5880 Transferrin immunological test system.

866.5890 Inter-alpha trypsin inhibitor immunological test system.

Subpart G-Tumor Associated Antigen
Immunological Test Systems

866.6010 Carcinoembryonic antigen (CEA) immunological test system as an aid in the detection and management of

cancer.

AUTHORITY: Secs. 501(f), 510, 513, 515, 520, 701(a), 52 Stat. 1055, 76 Stat. 794-795 as amended, 90 Stat. 540-546, 552-559, 565-574, 576-577 (21 U.S.C. 351(f), 360, 360c, 360e, 360j, 371(a)); 21 CFR 5.10.

SOURCE: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

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,