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(b) Classification. Class II (perform premarket notification procedures in ance standards).

subpart E of part 807 of this chapter

subject to $866.9. This exemption does $ 866.5320 Properdin factor B immunological test system.

not apply to factor deficiency tests

classified under $864.7290 of this chap(a) Identification. A properdin factor

ter. B immunological test system is a device that consists of the reagents used [47 FR 50823, Nov. 9, 1982, as amended at 65 to measure by immunochemical tech- FR 2312, Jan. 14, 2000) niques properdin factor B in serum and other body fluids. The deposition of

$ 866.5340 Ferritin immunological test properdin factor B in body tissues or a

system. corresponding depression

in the (a) Identification. A ferritin immunoamount of properdin factor B in serum logical test system is a device that and other body fluids is evidence of the consists of the reagents used to measinvolvement of the alternative to the

ure by immunochemical techniques the classical pathway of activation of com

ferritin (an iron-storing protein) in plement (a group of plasma proteins

serum and other body fluids. Measurewhich cause the destruction of cells

ments of ferritin aid in the diagnosis of which are foreign to the body). Meas

diseases affecting iron metabolism, urement of properdin factor B aids in

such as hemochromatosis (iron overthe diagnosis of several kidney diseases, e.g., chronic glomerulonephritis

load) and iron deficiency amemia. (inflammation of the glomeruli of the

(b) Classification. Class II (performkidney), lupus nephritis (kidney dis

ance standards). ease associated with a multisystem autoimmune disease, systemic lupus

8866.5350 Fibrinopeptide A immunoerythematosus), as well as several skin

logical test system. diseases, e.g., dermititis herpetiformis (a) Identification. A fibrinopeptide A (presence of vesicles on the skin that immunological test system is a device burn and itch), and pemphigus vulgaris that consists of the reagents used to (large vesicles on the skin). Other dis- measure by immunochemical techeases in which the alternate pathway niques the fibrinopeptide A (a bloodof complement activation has been im- clotting factor) in plasma and other plicated include rheumatoid arthritis, body fluids. Measurement of sickle cell anemia, and gram-negative fibrinopeptide A may aid in the diagbacteremia.

nosis and treatment of certain blood(b) Classification. Class II (special

clotting disorders. controls). The device is exempt from

(b) Classification. Class II (performthe premarket notification procedures

ance standards). in subpart E of part 807 of this chapter subject to $866.9.

$ 866.5360 Cohn fraction IV immuno[47 FR 50823, Nov. 9, 1982, as amended at 63

logical test system. FR 59227, Nov. 3, 1998]

(a) Identification. A Cohn fraction IV 8 866.5330 Factor XIII, A, S, immuno

immunological test system is a device logical test system.

that consists of or measures that frac(a) Identification. A factor XIII, A, S,

tion of plasma proteins, predominantly immunological test system is a device

alpha- and beta- globulins, used as a that consists of the reagents used to

raw material for the production of pure measure by immunochemical tech

alpha- or beta- globulins. Measurement niques the factor XIII (a bloodclotting

of specific alpha- or beta-globulins aids factor), in platelets (A) or serum (S). in the diagnosis of many diseases, such Measurements of factor XIII, A, S, aid

as Wilson's disease (an inherited disin the diagnosis and treatment of cer- ease affecting the liver and brain), tain bleeding disorders resulting from a Tangier's disease (absence of alpha-1deficiency of this factor.

lipoprotein), malnutrition, iron defi(b) Classification. Class I (general con- ciency anemia, red blood cell disorders, trols). The device is exempt from the and kidney disease.

to

(b) Classification. Class I. The device Measurement of alpha-globulin may is exempt from the premarket notifica- aid in the diagnosis of inflammatory tion procedures in subpart E of part 807 lesions, infections, severe burns, and a of this chapter.

variety of other conditions. (47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21,

(b) Classification. Class I (general con1982, as amended at 59 FR 63007, Dec. 7, 1994]

trols). The device is exempt from the

premarket notification procedures in $ 866.5370 Cohn fraction V immunolog. subpart E of part 807 of this chapter ical test system.

subject to $866.9. (a) Identification. A Cohn fraction V [47 FR 50823, Nov. 9, 1982, as amended at 65 immunological test system is a device FR 2312, Jan. 14, 2000] that consists of or measures that fraction of plasma containing predomi

$866.5420 Alpha-1-glycoproteins nantly albumin (a plasma protein).

immunological test system. This test aids in the diagnosis of dis- (a) Identification. An alpha-1eases where albumin levels may be de- glycoproteins immunological test syspressed, e.g., nephrosis (disease of the tem is a device that consists of the rekidney), proteinuria (protein in the agents used

measure by urine), gastroenteropathy (disease of immunochemical techniques alpha-1the stomach and small intestine), rheu- glycoproteins (a group of plasma promatoid arthritis, and viral hepatitis. teins found in the alpha-1 group when

(b) Classification. Class I. The device subjected to electrophoresis) in serum is exempt from the premarket notifica- and other body fluids. Measurement of tion procedures in subpart E of part 807 specific alpha-1-glycoproteins may aid of this chapter.

in the diagnosis of collagen (connective (47 FR 50823, Nov. 9, 1982, as amended at 59

tissue) disorders, tuberculosis, infecFR 63007, Dec. 7, 1994)

tions, extensive malignancy, and diabe

tes. $ 866.5380 Free secretory component (b) Classification. Class I (general conimmunological test system.

trols). The device is exempt from the (a) Identification. A free secretory

premarket notification procedures in component immunological test system

subpart E of part 807 of this chapter is a device that consists of the reagents

subject to 8 866.9. used to measure by immunochemical [47 FR 50823, Nov. 9, 1982, as amended at 65 techniques free secretory component FR 2312, Jan. 14, 2000] (normally a portion of the secretory IgA antibody molecule) in body fluids.

8866.5425 Alpha-2-glycoproteins Measurement of free secretory compo

immunological test system. nent (protein molecules) aids in the di- (a) Identification. An alpha-2agnosis or repetitive lung infections glycoproteins immunolgical test sysand other hypogammaglobulinemic tem is a device that consists of the reconditions (low antibody levels).

agents used

measure by (b) Classification. Class II (special immunochemical techniques the alphacontrols). The device is exempt from 2-glycoproteins (a group of plasma prothe premarket notification procedures teins found in the alpha-2 group when in subpart E of part 807 of this chapter subjected to electrophoresis) in serum subject to $866.9.

and other body fluids. Measurement of

alpha-2-glycoproteins aids in the diag(47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]

nosis of some cancers and genetically

inherited deficiencies of these plasma 8 866.5400 Alpha-globulin immunolog- proteins. ical test system.

(b) Classification. Class I (general con(a) Identification. An alpha-globulin

trols). The device is exempt from the immunological test system is a device

premarket notification procedures in that consists of the reagents used to

subpart E of part 807 of this chapter measure by immunochemical tech

subject to 8 866.9. niques the alpha-globulin (a serum pro- [47 FR 50823, Nov. 9, 1982, as amended at 65 tein) in serum and other body fluids. FR 2312, Jan. 14, 2000]

to

8866.5430 Beta-2-glycoprotein

I (b) Classification. Class II (special immunological test system.

controls). The device is exempt from (a) Identification.

beta-2

the premarket notification procedures A

in subpart E of part 807 of this chapter glycoprotein I immunological test sys

subject to 8 866.9. tem is a device that consists of the reagents used to measure by [47 FR 50823, Nov. 9, 1982, as amended at 63 immunochemical techniques the beta-2- FR 59227, Nov. 3, 1998] glycoprotein I (a serum protein) in

§ 866.5470 Hemoglobin immunological serum and other body fluids. Measure

test system. ment of beta-2-glycoprotein I aids in the diagnosis of an inherited deficiency

(a) Indentification. A hemoglobin of this serum protein.

immunological test system is a device (b) Classification. Class I (general con

that consists of the reagents used to trols). The device is exempt from the

measure by immunochemical tech

niques the different types of free hemopremarket notification procedures in

globin (the oxygen-carrying pigment in subpart E of part 807 of this chapter

red blood cells) in blood, urine, plasma, subject to $866.9.

or other body fluids. Measurements of [47 FR 50823, Nov. 9, 1982, as amended at 65 free hemoglobin aid in the diagnosis of FR 2312, Jan. 14, 2000)

various hematologic disorders, such as

sickle cell anemia, Fanconi's anemia (a $ 866.5440 Beta-2-glycoprotein III

rare inherited disease), aplastic anemia immunological test system.

(bone marrow does not produce enough (a)

Identification. A beta-2- blood cells), and leukemia (cancer of glycoprotein III immunological test

the blood-forming organs). system is a device that consists of the

(b) Classification. Class II (performreagents used to measure by

ance standards). immunochemical techniques the beta-2

$ 866.5490 Hemopexin immunological glycoprotein III (a serum protein) in

test system. serum and other body fluids. Measure

(a) ment of beta-2-glycoprotein III aids in

Indentification. A hemopexin the diagnosis of an inherited deficiency

immunological test system is a device of this serum protein and a variety of

that consists of the reagents used to other conditions.

measure by immunochemical tech

niques the hemopexin (a serum protein (b) Classification. Class I (general con

that binds heme, a component of hemotrols). The device is exempt from the

globin) in serum. Measurement of premarket notification procedures in

hemopexin aids in the diagnosis of varsubpart E of part 807 of this chapter

ious hematologic disorders, such as hesubject to 8 866.9.

molytic anemia (anemia due to short[47 FR 50823, Nov. 9, 1982, as amended at 65 ened in vivo survival of mature red FR 2312, Jan. 14, 2000)

blood cells and inability of the bone

marrow to compensate for their de$ 866.5460 Haptoglobin immunological creased life span) and sickle cell anetest system.

mia. (a) Identification. A haptoglobin (b) Classification. Class II (special immunological test system is a device

controls). The device is exempt from that consists of the reagents used to

the premarket notification procedures measure by immunochemical tech

in subpart E of part 807 of this chapter niques the haptoglobin (a protein that

subject to $866.9. binds hemoglobin, the oxygen-carrying (47 FR 50823, Nov. 9, 1982, as amended at 63 pigment in red blood cells) in serum. FR 59227, Nov. 3, 1998] Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases 8866.5500 Hypersensitivity pneumo(diseases in which the red blood cells

nitis immunological test system. rupture and release hemoglobin) re- (a) Identification. A hypersensitivity lated to the formation of hemoglobin- pneumonitis immunological test syshaptoglobin complexes and certain kid- tem is a device that consists of the reney diseases.

agents used

measure

by

to

immunochemical techniques the immunoglobulin antibodies in serum which react specifically with organic dust derived from fungal or animal protein sources. When these antibodies react with such dusts in the lung, immune complexes precipitate and trigger an inflammatory reaction (hypersensitivity pneumonitis). Measurement of these immunoglobulin G antibodies aids in the diagnosis of hypersensitivity pneumonitis and other allergic respiratory disorders.

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

tion 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) $866.5530 Immunoglobulin G (Fc frag.

ment specific) immunological test

system. (a) Identification. An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement

of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.

(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]

$ 866.5510 Immunoglobulins A, G, M, D,

and E immunological test system. (a) Identification.

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement

of

these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

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

8866.5540 Immunoglobulin G (Fd frag

ment specific) immunological test

system. (a) Identification. An immunoglobulin G (Fd fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the amino terminal (antigen-binding) end (Fd fragment) of the heavy chain (a subunit) of the immunoglobulin antibody molecule in serum. Measurement of immunoglobulin G Fd fragments aids in the diagnosis of plasma antibody-forming cell abnormalities.

(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 59 FR 63007, Dec. 7, 1994)

$ 866.5520 Immunoglobulin G (Fab

fragment specific) immunological

test system. (a) Identification. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia

(increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

(b) Classification. Class I. The device is exempt from the premarket notifica

of

$ 866.5550 Immunoglobulin (light

chain specific) immunological test

system. (a) Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such rheumatoid arthritis or systemic lupus erythematosus.

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

milk, other body fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of this 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 $866.9. [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000)

as

[blocks in formation]

measure

$ 866.5560 Lactic dehydrogenase

immunological test system. (a) Identification. A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood-forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions known to cause increased lactic dehydrogenase levels.

(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)

8866.5590 Lipoprotein X immunolog.

ical test system. (a) Identification. A lipoprotein X immunological test system is a device that consists of the reagents used to

by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver 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 $ 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

8866.5570 Lactoferrin immunological

test system. (a) Identification. A lactoferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron-binding protein with the ability to inhibit the growth of bacteria) in serum, breast

$ 866.5600 Low-density lipoprotein

immunological test system. (a) Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

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