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a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

(b) Classification. Class II (performance standards).

as

rather than culture or immunoassay technology; or

(C) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in 8812.3(k) of this chapter; and

(9) For near patient testing (point of care). [65 FR 2311, Jan. 14, 2000)

$ 866.1640 Antimicrobial susceptibility

test powder. (a) Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

(b) Classification. Class II (performance standards).

$ 866.1700 Culture medium for anti

microbial susceptibility tests. (a) Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

(b) Classification. Class II (performance standards).

Subpart B-Diagnostic Devices $866.1620 Antimicrobial susceptibility

test disc. (a) Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a discagar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens

to

antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs

Subpart C-Microbiology Devices $ 866.2050 Staphylococcal typing

bacteriophage. (a) Identification. A staphylococcal typing bacteriophage is device consisting of a bacterial virus intended for medical purposes to identify pathogenic staphylococcal bacteria through use of the bacteria's susceptibility to destruction by the virus. Test results are used principally for the collection of epidemiological information.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989)

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989)

8 866.2120 Anaerobic chamber.

(a) Identification. An anaerobic chamber is a device intended for medical purposes to maintain an anaerobic (oxygen free) environment. It is used to isolate and cultivate anaerobic microorganisms.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart of part 807. The device also is exempt from the good manufacturing practice regulation in part 820, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

$ 866.2180 Manual colony counter.

(a) Identification. A manual colony counter is a device intended for medical purposes that consists of a printed grid system superimposed on an illuminated screen. Petri plates containing bacterial colonies to be counted are placed on the screen for better viewing and ease of counting. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the good manufacturing practice regulation in part 820, with the exception of $820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files. $866.2300 Multipurpose culture

dium. (a) Identification. A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes for the cultivation and identification of several types of pathogenic microorganisms without the need of additional nutritional supplements. Test results aid in the diagnosis of disease and also provide epidemiological information diseases caused by these microorganisms.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)

8 866.2160 Coagulase plasma.

(a) Identification. Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genus Staphylococcus and provide epidemiological information on disease caused by these microorganisms.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996)

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8 866.2170 Automated colony counter.

(a) Identification. An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonies present on a bacteriological culture medium contained in a petri plate. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.

$ 866.2320 Differential culture

dium. (a) Identification. A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purposes to cultivate and identify different types of pathogenic microorganisms. The identification of these microorganisms is accomplished by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g., a color change) in a specific biochemical component(s) which indicates that specific metabolic reactions have occurred. Test results aid in the diagnosis of disease and also provide epidemiological information diseases caused by these microorganisms.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)

or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 this chapter. (47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)

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$ 866.2330 Enriched culture medium.

(a) Identification. An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal tissues. The device is used in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989] $ 866.2350 Microbiological assay cul

ture medium. (a) Identification. A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote

8866.2360 Selective culture medium.

(a) Identification. A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)

8 866.2390 Transport culture medium.

(a) Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

(b) Classification. Class I (general controls).

§ 866.2410 Culture medium for patho

genic Neisseria spp. (a) Identification. A culture medium for pathogenic Neisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenic Neisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.

(b) Classification. Class II (performance standards).

medium into petri dishes and then mechanically stack the petri dishes.

(b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807. This device also is exempt from the good manufacturing practice regulation in part 820, with the exception of $ 820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files.

8 866.2450 Supplement for culture

media. (a) Identification. A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal culture medium to produce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by pathogenic microorganisms.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

a

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)

$ 866.2420 Oxidase screening test for

gonorrhea. (a) Identification. An oxidase screening test for gonorrhea is an in vitro device that consists of the articles intended to identify by chemical reaction, cytochrome oxidase, an oxidizing enzyme that is associated with certain bacteria including Neisseria gonorrhoeae. A sample of a male's urethral discharge is obtained on swab which is placed into a wetting agent containing an ingredient that will react with cytochrome oxidase. When cytochrome oxidase is present, the swab turns a dark purple color within 3 minutes. Because it is unlikely that cytochrome oxidase-positive organisms other than Neisseria gonorrhoeae are present in the urethral discharge of males, the identification of cytochrome oxidase with this device indicates presumptive infection of the patient with the causative agent of gonorrhea.

(b) Classification. Class III (premarket approval) (transitional device).

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See $ 866.3. (47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]

$ 866.2480 Quality control kit for cul.

ture media. (a) Identification. A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]

$ 866.2440 Automated medium dis

pensing and stacking device. (a) Identification. An automated medium dispensing and stacking device is a device intended for medical purposes to dispense a microbiological culture

8866.2500 Microtiter diluting and dis- $866.2580 Gas-generating device. pensing device.

(a) Identification. A gas-generating (a) Identification. A microtiter dilut- device is a device intended for medical ing and dispensing device is a mechan- purposes that produces predetermined ical device intended for medical pur- amounts of selected gases to be used in poses to dispense or serially dilute very a closed chamber in order to establish small quantities of biological or chem- suitable atmospheric conditions for ical reagents for use in various diag- cultivation of microorganisms with nostic procedures.

special atmospheric requirements. The (b) Classification. Class I. The device device aids in the diagnosis of disease. is exempt from the premarket notifica- (b) Classification. Class I. The device tion procedures in subpart E of part 807 is exempt from the premarket notificaof this chapter.

tion procedures in subpart E of part 807 (47 FR 50823, Nov. 9, 1982, as amended at 54

of this chapter. FR 25046, June 12, 1989]

(47 FR 50823, Nov. 9, 1982, as amended at 54

FR 25046, June 12, 1989) $866.2540 Microbiological incubator. (a) Identification. A microbiological

8866.2600 Wood's fluorescent lamp. incubator is a device with various (a) Identification. A Wood's fluoreschambers or water-filled compartments cent lamp is a device intended for medin which controlled environmental con- ical purposes to detect fluorescent maditions, particularly temperature, are terials (e.g., fluorescein pigment promaintained. It is intended for medical duced by certain microorganisms) as purposes to cultivate microorganisms an aid in the identification of these and aid in the diagnosis of disease. microorganisms. The device aids in the

(b) Classification. Class I (general con- diagnosis of disease. trols). This device is exempt from pre- (b) Classification. Class I (general conmarket notification procedures in sub- trols). The device is exempt from the part E of part 807. The device also is ex- premarket notification procedures in empt from the good manufacturing subpart E of part 807. The device also is practice regulation in part 820 with the

exempt from the good manufacturing exception of $ 820.180, with respect to practice regulation in part 820 with the general requirements concerning exception of $ 820.180, with respect to records, and $820.198, with respect to general requirements concerning complaint files.

records, and $820.198 with respect to

complaint files. $ 866.2560 Microbial growth monitor.

(a) Identification. A microbial growth $ 866.2660 Microorganism differentiamonitor is a device intended for med

tion and identification device. ical purposes that measures the con- (a) Identification. A microorganism centration of bacteria suspended in a differentiation and identification deliquid medium by measuring changes vice is a device intended for medical in light scattering properties, optical purposes that consists of one or more density, electrical impedance, or by components, such as differential culmaking direct bacterial counts. The ture media, biochemical reagents, and device aids in the diagnosis of disease paper discs or paper strips impregnated caused by pathogenic microorganisms. with test reagents, that are usually

(b) Classification. Class I. With the ex- contained in individual compartments ception of automated blood culturing and used to differentiate and identify system devices that are used in testing selected microorganisms. The device for bacteria, fungi, and other micro- aids in the diagnosis of disease. organisms in blood and other normally (b) Classification. Class I (general consterile body fluids, this device is ex- trols). The device is exempt from the empt from the premarket notification premarket notification procedures in procedures in subpart E of part 807 of subpart E of part 807 of this chapter this chapter.

subject to $866.9. [47 FR 50823, Nov. 9, 1982, as amended at 60 [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 38482, July 27, 1995)

FR 2311, Jan. 14, 2000)

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