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trypanosomiasis, a disease caused by shock, renal failure, cardiovascular parasitic protozoans belonging to the collapse, and death. genus Trypanosoma. Trypanosomiasis (b) Classification. Class II (special in adults is a chronic disease charac- controls). The device is exempt from terized by fever, chills, headache, and the premarket notification procedures vomiting. Central nervous system in in subpart E of part 807 of this chapter volvement produces typical sleeping subject to $866.9. sickness syndrome: physical exhaus

[47 FR 50823, Nov. 9, 1982, as amended at 63 tion, inability to eat, tissue wasting,

FR 59227, Nov. 3, 1998] and eventual death. Chagas disease, an acute form of trypanosomiasis in chil- $866.3940 West Nile virus serological dren, most seriously affects the central reagents. nervous system and heart muscle.

(a) Identification. West Nile virus se(b) Classification. Class I (general con

rological reagents are devices that controls).

sist of antigens and antisera for the de

tection of anti-West Nile virus IgM 8 866.3900 Varicella-zoster virus sero

antibodies, in human serum, from indilogical reagents.

viduals who have signs and symptoms (a) Identification. Varicella-zoster consistent with viral meningitis/envirus serological reagents are devices cephalitis. The detection aids in the that consist of antigens and antisera clinical laboratory diagnosis of viral used in serological tests to identify meningitis/encephalitis caused by West antibodies to varicella-zoster in serum. Nile virus. The identification aids in the diagnosis (b) Classification. Class II (special of diseases caused by varicella-zoster controls). The special control is FDA's viruses and provides epidemiological guidance entitled “Class II Special information on these diseases. Controls Guidance Document: SeroVaricella (chicken pox) is a mild, high- logical Reagents for the Laboratory Dily infectious disease, chiefly of chil agnosis of West Nile Virus." See dren. Zoster (shingles) is the recurrent $ 866.1(e) for the availability of this form of the disease, occurring in adults guidance document. who were previously infected with

[68 FR 61745, Oct. 30, 2003] varicella-zoster viruses. Zoster is the response (characterized by a rash) of

Subpart E-Immunology Laborathe partially immune host to a reactivation of varicella viruses present in

tory Equipment and Relatent form in the patient's body.

agents (b) Classification. Class II (perform

8866.4070 RNA Preanalytical Systems. ance standards).

(a) Identification. RNA Preanalytical $ 866.3930 Vibrio cholerae serological Systems are devices intended to colreagents.

lect, store, and transport patient speci(a) Identification. Vibrio cholerae sero

mens, and stabilize intracellular RNA

from the specimens, for subsequent isological reagents are devices that are

lation used in the agglutination (an antigen

and purification of the antibody clumping reaction) test to

intracellular RNA for RT-PCR used in identify Vibrio cholerae from cultured

in vitro molecular diagnostic testing. isolates derived from clinical speci

(b) Classification. Class II (special mens. The identification aids in the di

controls). The special control is FDA's agnosis of cholera caused by the bac

guidance document entitled "Class II terium Vibrio cholerae and provides epi

Special Controls Guidance Document:

RNA Preanalytical Systems (RNA Coldemiological information on cholera.

lection, Stabilization and Purification Cholera is an acute infectious disease

System for RT-PCR Used in Molecular characterized by severe diarrhea with extreme fluid and electrolyte (salts)

Diagnostic Testing)." See $ 866.1(e) for depletion, and by vomiting, muscle

the availability of this guidance docu

ment. cramps, and prostration. If untreated, the severe dehydration may lead to [70 FR 49863, Aug. 25, 2005]

light emitted by the fluorochrome label is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the fluorescence value and is used to measure the concentration of antigen-antibody complexes.

(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 the limitations in $ 866.9. (47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001]

$866.4100 Complement reagent.

(a) Identification. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.

(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 the limitations in 8 866.9. [47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001) 8 866.4500 Immunoelectrophoresis

equipment. (a)

Identification. Immunoelectrophoresis equipment for clinical use with its electrical power supply is a device used for separating protein

molecules. Immunoelectrophoresis is a procedure in which a complex protein mixture is placed in an agar gel and the various proteins are separated on the basis of their relative mobilities under the influence of an electric current. The separated proteins are then permitted to diffuse through the agar toward a multispecific antiserum, allowing precipitation and visualization of the separate complexes.

(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 the limitations in $ 866.9. (47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001]

$ 866.4540 Immunonephelometer

equipment. (a)

Identification. Immunonephelometer equipment for clinical use with its electrical power supply is a device that measures light scattering from antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light passed through a solution is scattered by the particles in suspension. The amount of light is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the lightscattering value and is used to measure the concentration of antigen-antibody complexes. This generic type of device includes devices with various kinds of light sources, such as laser equipment.

(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 the limitations in § 866.9. (47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001)

8866.4520 Immunofluorometer equip

ment. (a) Identification. Immunofluorometer equipment for clinical use with its electrical power supply is a device used to measure the fluorescence of fluorochrome-labeled antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light is passed through a solution in which a fluorochrome has been selectively attached to serum protein antibody molecules in suspension. The amount of

$ 866.4600 Ouchterlony agar plate.

(a) Identification. An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen-antibody reactions. In immunodiffusion, antibodies and antigens migrate toward each other premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in $ 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38792, July 25, 2001)

through gel which originally contained neither of these reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and is immobilized.

(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 the limitations in $ 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001]

$ 866.4700 Automated fluorescence in

situ hybridization (FISH) enumera

tion systems. (a) Identification. An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed. paraffin-embedded human tissue specimens.

(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems." See 866.1(e) for the availability of this guidance document. [70 FR 14534, Mar. 23, 2005]

$866.4830 Rocket immunoelectro

phoresis equipment. (a) Identification. Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure

called

rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height of the peak (or the area under the peak) is proportional to the concentration of the protein.

(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 the limitations in $ 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001]

$ 866.4900 Support gel.

(a) Identification. A support gel for clinical use is a device that consists of an agar or agarose preparation that is used while measuring various kinds of, or parts of, protein molecules by various immunochemical techniques, such as

immunoelectrophoresis, immunodiffusion, or chromatography.

(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 the limitations in $ 866.9. (47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 2001)

$ 866.4800 Radial immunodiffusion

plate. (a) Identification. A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally contains specific antibodies. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and immobilized.

(b) Classification. Class I (general controls). The device is exempt from the

Subpart F-Immunological Test

Systems $ 866.5040 Albumin immunological test

system. (a) Identification. An albumin immunological test system is a device that consists of the reagents used to

measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

(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 8 866.9. (47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]

immunochemical techniques alpha-1antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha-1antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.

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

8866.5060 Prealbumin immunological

test system. (a) Identification. A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

(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 $866.9. (47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]

$ 866.5090 Antimitochondrial antibody

immunological test system. (a) Identification.

An antimitochondrial

antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).

(b) Classification. Class II (performance standards). $ 866.5100 Antinuclear antibody

immunological test system. (a) Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

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

$866.5065 Human allotypic marker

immunological test system. (a) Identification. A human allotypic marker immunological test system is a device that consists of the reagents used to identify by immunochemical techniques the inherited human protein allotypic markers (such as nGm, nAz m, and Km allotypes) in serum and other body fluids. The identification may be used while studying population genetics.

(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 8 866.9. (47 FR 50823. Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000)

$ 866.5080 Alpha-l-antichymotrypsin

immunological test system. (a) Identification. An alpha-1antichymotrypsin immunological test system is a device that consists of the reagents used to measure by

$ 866.5110 Antiparietal antibody

immunological test system. (a) Identification. An antiparietal antibody immunological test system is a device that consists of the reagents

used to measure by immunochemical urine and plasma. Immunoglobulin techniques the specific antibody for molecules normally consist of pairs of gastric parietal cells in serum and polypeptide chains (subunits) of unother body fluids. Gastric parietal cells equal size (light chains and heavy are those cells located in the stomach chains) bound together by several dithat produce a protein that enables vi sulfide bridges. In some cancerous contamin B12 to be absorbed by the body. ditions, there is a proliferation of one The measurements aid in the diagnosis plasma cell (antibody-producing cell) of vitamin B12 deficiency (or pernicious with excess production of light chains anemia), atrophic gastritis (inflamma- of one specific kind (monoclonal light tion of the stomach), and autoimmune chains). These free homogeneous light connective tissue diseases (diseases re chains not associated with an sulting when the body produces anti immunoglobulin molecule can be found bodies against its own tissues).

in urine and plasma, and have been (b) Classification. Class II (perform

called Bence-Jones proteins. Measureance standards).

ment of Bence-Jones proteins and de

termination that they are monoclonal $ 866.5120 Antismooth muscle antibody aid in the diagnosis of multiple immunological test system.

myeloma (malignant proliferation of (a) Identification. An antismooth mus plasma cells), Waldenstrom's cle antibody immunological test sys

macroglobulinemia (increased productem is a device that consists of the re tion of large immunoglobulins by agents used to measure by spleen and bone marrow cells), leuimmunochemical techniques the kemia (cancer of the blood-forming orantismooth muscle antibodies (anti- gans), and lymphoma (cancer of the bodies to nonstriated, involuntary lymphoid tissue). muscle) in serum. The measurements (b) Classification. Class II (performaid in the diagnosis of chronic hepa- ance standards). titis (inflammation of the liver) and autoimmune connective tissue diseases

8866.5160 Beta-globulin immunolog

ical test system. (diseases resulting from antibodies produced against the body's own tissues).

(a) Identification. A beta-globulin (b) Classification Class II (perform

immunological test system is a device ance standards).

that consists of reagents used to meas

ure by immunochemical techniques $ 866.5130 Alpha-l-antitrypsin

beta globulins (serum protein) in serum immunological test system.

and other body fluids. Beta-globulin (a) Identification. An alpha-1

proteins include beta-lipoprotein, antitrypsin immunological test system

transferrin, glycoproteins, and comis a device that consists of the reagents plement, and are rarely associated with used to measure by immunochemical specific pathologic disorders. techniques the alpha-1-antitrypsin (a

(b) Classification. Class I (general conplasma protein) in serum, other body trols). The device is exempt from the fluids, and tissues. The measurements

premarket notification procedures in aid in the diagnosis of several condi

subpart E of part 807 of this chapter tions including juvenile and adult cir- subject to § 866.9. rhosis of the liver. In addition, alpha-1- [47 FR 50823, Nov. 9, 1982, as amended at 65 antitrypsin deficiency has been associ FR 2312, Jan. 14, 2000) ated with pulmonary emphysema.

(b) Classification. Class II (perform- $866.5170 Breast milk immunological ance standards).

test system.

(a) Identification. A breast milk 8866.5150 Bence-Jones

proteins immunological test system is a device immunological test system.

that consists of the reagents used to (a) Identification. A Bence-Jones pro- measure by immunochemical techteins immunological test system is a niques the breast milk proteins. device that consists of the reagents (b) Classification. Class I (general conused to measure by immunochemical trols). The device is exempt from the techniques the Bence-Jones proteins in premarket notification procedures in

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