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(b) Classification. Class II (performance standards). (45 FR 60646, Sept. 12, 1980)

centrate 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]

$ 864.9320 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)

$ 864.9600 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]

$ 864.9400 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)

8 864.9650 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)

$ 864.9550 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]

8864.9700 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]

8 864.9575 Environmental chamber for

storage of platelet concentrate. (a) Identification. An environmental chamber for storage of platelet con

$ 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 8 864.9. (45 FR 60650, Sept. 12, 1980, as amended at 65 FR 2311, Jan. 14, 2000)

866.2440 Automated medium dispensing and

stacking device. 866.2450 Supplement for culture media. 866.2480 Quality control kit for culture

media. 866.2500 Microtiter diluting and dispensing

device. 866.2540 Microbiological incubator. 866.2560 Microbial growth monitor. 866.2580 Gas-generating device. 866.2600 Wood's fluorescent lamp. 866.2660 Microorganism differentiation and

identification device. 866.2850 Automated zone reader. 866.2900 Microbiological specimen collection

and transport device.

$ 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.

(b) Classification. Class II (performance standards). (45 FR 60651, Sept. 12, 1980)

PART 866-IMMUNOLOGY AND

MICROBIOLOGY DEVICES

Subpart A-General Provisions

Sec. 866.1 Scope. 866.3 Effective dates of requirement for pre

market approval. 866.9 Limitations of exemptions from sec

tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B-Diagnostic Devices 866.1620 Antimicrobial susceptibility test

disc. 866.1640 Antimicrobial susceptibility test

powder. 866.1700 Culture medium for antimicrobial

susceptibility tests.

Subpart D-Serological Reagents 866.3010 Acinetobacter calcoaceticus sero

logical 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 re

agents. 866.3120 Chlamydia serological reagents. 866.3125 Citrobacter spp. serological reagents. 866.3135 Coccidioides immitis serological re

agents. 866.3140 Corynebacterium spp. serological re

agents. 866.3145 Coxsackievirus serological re

agents. 866.3165 Cryptococcus neoformans serological

reagents. 866.3175 Cytomegalovirus serological re

agents. 866.3200 Echinococcus spp. serological re

agents. 866.3205 Echovirus serological reagents. 866.3220 Entamoeba histolytica serological re

agents. 866.3235 Epstein-Barr virus serological re

agents. 866.3240 Equine encephalomyelitis virus se

rological reagents. 866.3250 Erysipelothrix rhusiopathiae sero

logical reagents. 866.3255 Escherichia coli serological reagents. 866.3270 Flavobacterium spp. serological re

agents. 866.3280 Francisella tularensis serological re

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

agents. 866.3305 Herpes simplex virus serological re

agents. 866.3320 Histoplasma capsulatum serological

reagents. 866.3330 Influenza virus serological

Subpart C-Microbiology Devices

866.2050 Staphylococcal

typing bacteriophage. 866.2120 Anaerobic chamber. 866.2160 Coagulase plasma. 866.2170 Automated colony counter. 866.2180 Manual colony counter. 866.2300 Multipurpose culture medium. 866.2320 Differential culture medium. 866.2330 Enriched culture medium. 866.2350 Microbiological assay culture me

dium. 866.2360 Selective culture medium. 866.2390 Transport culture medium. 866.2410 Culture medium for pathogenic

Neisseria spp. 866.2420 Oxidase screening test for gonor

agents.

rhea.

re

866.4900 Support gel.

Subpart F-Immunological Test Systems

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 immunofluorescent reagents. 866.3375 Mycoplasma spp. serological re

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

reagents. 866.3400 Parainfluenza virus serological re

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

reagents. 866.3415 Pseudomonas spp. serological re

agents. 866.3460 Rabiesvirus immunofluorescent re

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

logical 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 re

agents. 866.3630 Serratia spp. serological reagents. 866.3660 Shigella spp. serological reagents. 866.3680 Sporothrir schenckii serological re

agents. 866.3700 Staphylococcus aureus serological re

agents. 866.3720 Streptococcus spp. exoenzyme

agents. 866.3740 Streptococcus spp. serological re

agents. 866.3780 Toxoplasma gondii serological re

agents. 866.3820 Treponema pallidum nontreponemal

test reagents. 866.3830 Treponema pallidum treponemal test

reagents. 866.3850 Trichinella spiralis serological re

agents. 866.3870 Trypanosoma spp. serological re

agents. 866.3900 Varicella-zoster virus serological

reagents. 866.3930 Vibrio cholerae serological reagents.

866.5040 Albumin immunological test sys

tem. 866.5060 Prealbumin immunological test

system. 866.5065 Human allotypic marker immuno

logical test system. 866.5080 Alpha-1-antichymotrypsin immuno

logical test system. 866.5090 Antimitochondrial

antibody immunological test system. 866.5100 Antinuclear antibody immunolog

ical test system. 866.5110 Antiparietal antibody immunolog

ical test system. 866.5120 Antismooth muscle antibody

immunological test system. 866.5130 Alpha-1-antitrypsin immunological

test system. 866.5150 Bence-Jones proteins immunolog

ical test system. 866.5160 Beta-globulin immunological test

system. 866.5170 Breast milk immunological test

system. 866.5200 Carbonic anhydrase B and с

immunological test system. 866.5210 Ceruloplasmin immunological test

system. 866.522 Cohn fraction II immunological test

system. 866.5230 Colostrum immunological test sys

tem. 866.5240 Complement components immuno

logical test system. 866.5250 Complement Ci inhibitor

(inactivator) immunological test system. 866.5260 Complement Cзь inactivator

immunological test system. 866.5270 C-reactive protein immunological

test system. 866.5320 Properidin factor B immunological

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

test system. 866.5340 Ferritin immunological test sys

tem. 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 immuno

logical test system. 866.5400 Alpha-globulin immunological test

system. 866.5420 Alpha-1-glycoproteins immunolog

ical test system. 866.5425 Alpha-2-glycoproteins immunolog

ical test system. 866.5430 Beta-2-glycoprotein I immunolog

ical test system.

re

Subpart 6-Immunology Laboratory

Equipment and Reagents 866.4100 Complement reagent. 866.4500 Immunoelectrophoresis equipment. 866.4520 Immunofluorometer equipment. 866.4540 Immunonephelometer equipment. 866.4600 Ouchterlony agar plate. 866.4800 Radial immunodiffusion plate. 866.4830 Rocket immunoelectrophoresis

equipment.

Subpart G-Tumor Associated Antigen

Immunological Test Systems 866.6010 Tumor associated antigen immuno

logical test system. AUTHORITY: 21 U.S.C. 351, 360, 3600, 360e, 360j, 371.

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

Subpart A-General Provisions

a

866.5440 Beta-2-glycoprotein III immunolog

ical test system. 866.5460 Haptoglobin immunological test

system. 866.5470 Hemoglobin immunological test

system. 866.5490 Hemopexin immunological test sys

tem. 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 spe

cific) immunological test system. 866.5560 Lactic dehydrogenase immunolog

ical test system. 866.5570 Lactoferrin immunological test sys

tem. 866.5580 Alpha-1-lipoprotein immunological

test system. 866.5590 Lipoprotein X immunological test

system. 866.5600 Low-density lipoprotein immuno

logical test system. 866.5620 Alpha-2-macroglobulin immunolog

ical test system. 866.5630 Beta-2-microglobulin immunolog

ical test system. 866.5640 Infectious mononucleosis immuno

logical test system. 866.5660 Multiple autoantibodies immuno

logical test system. 866.5680 Myoglobin immunological test sys

tem. 866.5700 Whole human plasma or serum

immunological test system. 866.5715 Plasminogen immunological test

system. 866.5735 Prothrombin immunological test

system. 866.5750 Radioallergosorbent

(RAST) immunological test system. 866.5765 Retinol-binding protein immuno

logical test system. 866.5775 Rheumatoid factor immunological

test system. 866.5785 Anti-Saccharomyces cerevisiae (S.

cerevisiae) antibody (ASCA) test sys

tems. 866.5800 Seminal fluid (sperm) immunolog

ical test system. 866.5820 Systemic lupus erythematosus

immunological test system. 866.5860 Total spinal fluid immunological

test system. 866.5870 Thyroid autoantibody immunolog

ical test system. 866.5880 Transferrin immunological test sys

tem. 866.5890 Inter-alpha trypsin

inhibitor immunological test system.

$866.1 Scope.

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

(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 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)

an

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 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.

tional 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 amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

(52 FR 17733, May 11, 1987; 52 FR 22577, June 12, 1987]

(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 transi

$ 866.9 Limitations of exemptions from

section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology

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