§ 866.5040 21 CFR Ch. I (4–1–04 Edition)

Subpart F—Immunological Test subpart E of part 807 of this chapter Systems subject to § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 65 § 866.5040 immunological test FR 2312, Jan. 14, 2000] system. § 866.5080 Alpha-1-antichymotrypsin (a) Identification. An albumin immun- immunological test system. ological test system is a device that (a) Identification. An alpha-1- consists of the reagents used to meas- antichymotrypsin immunological test ure by immunochemical techniques the system is a device that consists of the albumin (a plasma protein) in serum reagents used to measure by and other body fluids. Measurement of immunochemical techniques alpha-1- albumin aids in the diagnosis of kidney antichymotrypsin (a protein) in serum, and intestinal diseases. other body fluids, and tissues. Alpha-1- (b) Classification. Class II (special antichymotrypsin helps protect tissues controls). The device is exempt from against proteolytic (protein-splitting) the premarket notification procedures enzymes released during infection. in subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to § 866.9. ance standards). [47 FR 50823, Nov. 9, 1982, as amended at 63 § 866.5090 Antimitochondrial FR 59227, Nov. 3, 1998] immunological test system. (a) Identification. An § 866.5060 Prealbumin immunological test system. antimitochondrial antibody immuno- logical test system is a device that (a) Identification. A prealbumin consists of the reagents used to meas- immunological test system is a device ure by immunochemical techniques the that consists of the reagents used to antimitochondrial in human measure by immunochemical tech- serum. The measurements aid in the niques the prealbumin (a plasma pro- diagnosis of diseases that produce a tein) in serum and other body fluids. spectrum of autoantibodies (antibodies Measurement of prealbumin levels in produced against the body’s own tis- serum may aid in the assessment of the sue), such as primary biliary cirrhosis patient’s nutritional status. (degeneration of liver tissue) and (b) Classification. Class I (general con- chronic active hepatitis (inflammation trols). The device is exempt from the of the liver). premarket notification procedures in (b) Classification. Class II (perform- subpart E of part 807 of this chapter ance standards). subject to § 866.9. § 866.5100 Antinuclear antibody [47 FR 50823, Nov. 9, 1982, as amended at 65 immunological test system. FR 2312, Jan. 14, 2000] (a) Identification. An antinuclear antibody immunological test system is § 866.5065 Human allotypic marker a device that consists of the reagents immunological test system. used to measure by immunochemical (a) Identification. A human allotypic techniques the autoimmune antibodies marker immunological test system is a in serum, other body fluids, and tissues device that consists of the reagents that react with cellular nuclear con- used to identify by immunochemical stituents (molecules present in the nu- techniques the inherited human pro- cleus of a cell, such as ribonucleic acid, tein allotypic markers (such as nGm, deoxyribonucleic acid, or nuclear pro- teins). The measurements aid in the di- nA m, and Km allotypes) in serum and 2 agnosis of systemic lupus other body fluids. The identification erythematosus (a multisystem auto- may be used while studying population immune disease in which antibodies at- genetics. tack the victim’s own tissues), hepa- (b) Classification. Class I (general con- titis (a liver disease), rheumatoid ar- trols). The device is exempt from the thritis, Sjogren’s syndrome (arthritis premarket notification procedures in with inflammation of the eye, eyelid,

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and salivary glands), and systemic scle- antitrypsin deficiency has been associ- rosis (chronic hardening and shrinking ated with pulmonary emphysema. of many body tissues). (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). § 866.5150 Bence-Jones proteins § 866.5110 Antiparietal antibody immunological test system. immunological test system. (a) Identification. A Bence-Jones pro- (a) Identification. An antiparietal teins immunological test system is a antibody immunological test system is device that consists of the reagents a device that consists of the reagents used to measure by immunochemical used to measure by immunochemical techniques the Bence-Jones proteins in techniques the specific antibody for urine and plasma. Immunoglobulin gastric parietal cells in serum and molecules normally consist of pairs of other body fluids. Gastric parietal cells polypeptide chains (subunits) of un- are those cells located in the stomach equal size (light chains and heavy that produce a protein that enables vi- chains) bound together by several di- tamin B12 to be absorbed by the body. sulfide bridges. In some cancerous con- The measurements aid in the diagnosis ditions, there is a proliferation of one of vitamin B deficiency (or pernicious 12 plasma cell (antibody-producing cell) anemia), atrophic gastritis (inflamma- with excess production of light chains tion of the stomach), and autoimmune of one specific kind (monoclonal light connective tissue diseases (diseases re- sulting when the body produces anti- chains). These free homogeneous light bodies against its own tissues). chains not associated with an (b) Classification. Class II (perform- immunoglobulin molecule can be found ance standards). in urine and plasma, and have been called Bence-Jones proteins. Measure- § 866.5120 Antismooth muscle antibody ment of Bence-Jones proteins and de- immunological test system. termination that they are monoclonal (a) Identification. An antismooth mus- aid in the diagnosis of multiple cle antibody immunological test sys- myeloma (malignant proliferation of tem is a device that consists of the re- plasma cells), Waldenstrom’s agents used to measure by macroglobulinemia (increased produc- immunochemical techniques the tion of large immunoglobulins by antismooth muscle antibodies (anti- spleen and bone marrow cells), leu- bodies to nonstriated, involuntary kemia (cancer of the blood-forming or- muscle) in serum. The measurements gans), and lymphoma (cancer of the aid in the diagnosis of chronic hepa- lymphoid tissue). titis (inflammation of the liver) and (b) Classification. Class II (perform- autoimmune connective tissue diseases ance standards). (diseases resulting from antibodies pro- duced against the body’s own tissues). § 866.5160 Beta- immunolog- (b) Classification Class II (perform- ical test system. ance standards). (a) Identification. A beta-globulin immunological test system is a device § 866.5130 Alpha-1-antitrypsin immun- that consists of reagents used to meas- ological test system. ure by immunochemical techniques (a) Identification. An alpha-1- beta (serum protein) in serum antitrypsin immunological test system and other body fluids. Beta-globulin is a device that consists of the reagents proteins include beta-lipoprotein, used to measure by immunochemical , glycoproteins, and com- techniques the alpha-1-antitrypsin (a plement, and are rarely associated with plasma protein) in serum, other body specific pathologic disorders. fluids, and tissues. The measurements aid in the diagnosis of several condi- (b) Classification. Class I (general con- tions including juvenile and adult cir- trols). The device is exempt from the rhosis of the liver. In addition, alpha-1- premarket notification procedures in

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subpart E of part 807 of this chapter § 866.5220 Cohn fraction II immunolog- subject to § 866.9. ical test system. [47 FR 50823, Nov. 9, 1982, as amended at 65 (a) Identification. A Cohn fraction II FR 2312, Jan. 14, 2000] immunological test system is a device that consists of the reagents that con- § 866.5170 Breast milk immunological tain or are used to measure that frac- test system. tion of plasma containing protein (a) Identification. A breast milk gamma globulins, predominantly of the immunological test system is a device IgG class. The device may be used as a that consists of the reagents used to coprecipitant in radioimmunoassay measure by immunochemical tech- methods, as raw material for the puri- niques the breast milk proteins. fication of IgG subclasses, and to re- duce nonspecific adsorption of plasma (b) Classification. Class I (general con- proteins in immunoassay techniques. trols). The device is exempt from the Measurement of these proteins aids in premarket notification procedures in the diagnosis of any disease concerned subpart E of part 807 of this chapter with abnormal levels of IgG gamma subject to the limitations in § 866.9. globulins such as agammaglobulinemia [47 FR 50823, Nov. 9, 1982, as amended at 59 or multiple myeloma. FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 866.5200 Carbonic anhydrase B and subpart E of part 807 of this chapter C immunological test system. subject to the limitations in § 866.9. (a) Identification. A carbonic anhy- [47 FR 50823, Nov. 9, 1982, as amended at 59 drase B and C immunological test sys- FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, tem is a device that consists of the re- 2001] agents used to measure by immunochemical techniques specific § 866.5230 Colostrum immunological carbonic anhydrase protein molecules test system. in serum and other body fluids. Meas- (a) Identification. A colostrum urements of carbonic anhydrase B and immunological test system is a device C aid in the diagnosis of abnormal he- that consists of the reagents used to moglobin metabolism. measure by immunochemical tech- (b) Classification. Class I (general con- niques the specific proteins in colos- trols). The device is exempt from the trum. Colostrum is a substance ex- premarket notification procedures in creted by the mammary glands during subpart E of part 807 of this chapter pregnancy and until production of subject to § 866.9. breast milk begins 1 to 5 days after childbirth. [47 FR 50823, Nov. 9, 1982, as amended at 65 (b) Classification. Class I (general con- FR 2312, Jan. 14, 2000] trols). The device is exempt from the § 866.5210 immunolog- premarket notification procedures in ical test system. subpart E of part 807 of this chapter subject to the limitations in § 866.9. (a) Identification. A ceruloplasmin immunological test system is a device [47 FR 50823, Nov. 9, 1982, as amended at 59 that consists of the reagents used to FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, measure by immunochemical tech- 2001] niques the ceruloplasmin (copper- § 866.5240 Complement components transporting serum protein) in serum, immunological test system. other body fluids, or tissues. Measure- (a) Identification. A complement com- ments of ceruloplasmin aid in the diag- ponents immunological test system is nosis of copper metabolism disorders. a device that consists of the reagents (b) Classification. Class II (perform- used to measure by immunochemical ance standards). techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and 270

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C9, in serum, other body fluids, and tis- niques the C-reactive protein in serum sues. Complement is a group of serum and other body fluids. Measurement of proteins which destroy infectious C-reactive protein aids in evaluation of agents. Measurements of these proteins the amount of injury to body tissues. aids in the diagnosis of immunologic (b) Classification. Class II (perform- disorders, especially those associated ance standards). with deficiencies of complement com- ponents. § 866.5320 factor B immuno- (b) Classification. Class II (perform- logical test system. ance standards). (a) Identification. A properdin factor [47 FR 50823, Nov. 9, 1982, as amended at 53 B immunological test system is a de- FR 11253, Apr. 6, 1988] vice that consists of the reagents used to measure by immunochemical tech- § 866.5250 Complement C1 inhibitor niques properdin factor B in serum and (inactivator) immunological test other body fluids. The deposition of system. properdin factor B in body tissues or a (a) Identification. A complement C1 corresponding depression in the inhibitor (inactivator) immunological amount of properdin factor B in serum test system is a device that consists of and other body fluids is evidence of the the reagents used to measure by involvement of the alternative to the immunochemical techniques the com- classical pathway of activation of com- plement C1 inhibitor (a plasma protein) plement (a group of plasma proteins in serum. Complement C1 inhibitor oc- which cause the destruction of cells curs normally in plasma and blocks the which are foreign to the body). Meas- action of the C1 component of com- urement of properdin factor B aids in plement (a group of serum proteins the diagnosis of several kidney dis- which destroy infectious agents). Meas- eases, e.g., chronic glomerulonephritis urement of complement C1 inhibitor (inflammation of the glomeruli of the aids in the diagnosis of hereditary kidney), lupus nephritis (kidney dis- angioneurotic edema (increased blood ease associated with a multisystem vessel permeability causing swelling of autoimmune disease, systemic lupus tissues) and a rare form of angioedema erythematosus), as well as several skin associated with lymphoma (lymph node diseases, e.g., dermititis herpetiformis cancer). (presence of vesicles on the skin that (b) Classification. Class II (perform- burn and itch), and pemphigus vulgaris ance standards). (large vesicles on the skin). Other dis- eases in which the alternate pathway § 866.5260 Complement C3b inactivator of complement activation has been im- immunological test system. plicated include rheumatoid arthritis, (a) Identification. A complement C3b sickle cell anemia, and gram-negative inactivator immunological test system bacteremia. is a device that consists of the reagents (b) Classification. Class II (special used to measure by immunochemical controls). The device is exempt from techniques the complement C3b the premarket notification procedures inactivator (a plasma protein) in in subpart E of part 807 of this chapter serum. Complement is a group of serum subject to § 866.9. proteins that destroy infectious agents. Measurement of complement C3b [47 FR 50823, Nov. 9, 1982, as amended at 63 inactivator aids in the diagnosis of in- FR 59227, Nov. 3, 1998] herited antibody dysfunction. (b) Classification. Class II (perform- § 866.5330 Factor XIII, A, S, immuno- ance standards). logical test system. (a) Identification. A factor XIII, A, S, § 866.5270 C-reactive protein immuno- immunological test system is a device logical test system. that consists of the reagents used to (a) Identification. A C-reactive protein measure by immunochemical tech- immunological test system is a device niques the factor XIII (a bloodclotting that consists of the reagents used to factor), in platelets (A) or serum (S). measure by immunochemical tech- Measurements of factor XIII, A, S, aid

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in the diagnosis and treatment of cer- ciency anemia, red blood cell disorders, tain bleeding disorders resulting from a and kidney disease. deficiency of this factor. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 866.9. subject to § 866.9. This exemption does not apply to factor deficiency tests [47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, classified under § 864.7290 of this chap- 1982, as amended at 59 FR 63007, Dec. 7, 1994; ter. 66 FR 38793, July 25, 2001] [47 FR 50823, Nov. 9, 1982, as amended at 65 § 866.5370 Cohn fraction V immunolog- FR 2312, Jan. 14, 2000] ical test system. § 866.5340 Ferritin immunological test (a) Identification. A Cohn fraction V system. immunological test system is a device (a) Identification. A ferritin immuno- that consists of or measures that frac- logical test system is a device that tion of plasma containing predomi- consists of the reagents used to meas- nantly albumin (a plasma protein). ure by immunochemical techniques the This test aids in the diagnosis of dis- ferritin (an iron-storing protein) in eases where albumin levels may be de- serum and other body fluids. Measure- pressed, e.g., nephrosis (disease of the ments of ferritin aid in the diagnosis of kidney), proteinuria (protein in the diseases affecting iron metabolism, urine), gastroenteropathy (disease of such as hemochromatosis (iron over- the stomach and small intestine), rheu- load) and iron deficiency amemia. matoid arthritis, and viral hepatitis. (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the § 866.5350 Fibrinopeptide A immuno- premarket notification procedures in logical test system. subpart E of part 807 of this chapter (a) Identification. A fibrinopeptide A subject to the limitations in § 866.9. immunological test system is a device [47 FR 50823, Nov. 9, 1982, as amended at 59 that consists of the reagents used to FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, measure by immunochemical tech- 2001] niques the fibrinopeptide A (a blood- clotting factor) in plasma and other § 866.5380 Free secretory component body fluids. Measurement of immunological test system. fibrinopeptide A may aid in the diag- (a) Identification. A free secretory nosis and treatment of certain blood- component immunological test system clotting disorders. is a device that consists of the reagents (b) Classification. Class II (perform- used to measure by immunochemical ance standards). techniques free secretory component § 866.5360 Cohn fraction IV immuno- (normally a portion of the secretory logical test system. IgA antibody molecule) in body fluids. (a) Identification. A Cohn fraction IV Measurement of free secretory compo- immunological test system is a device nent (protein molecules) aids in the di- that consists of or measures that frac- agnosis or repetitive lung infections tion of plasma proteins, predominantly and other hypogammaglobulinemic alpha- and beta- globulins, used as a conditions (low antibody levels). raw material for the production of pure (b) Classification. Class II (special alpha- or beta- globulins. Measurement controls). The device is exempt from of specific alpha- or beta- globulins aids the premarket notification procedures in the diagnosis of many diseases, such in subpart E of part 807 of this chapter as Wilson’s disease (an inherited dis- subject to § 866.9. ease affecting the liver and brain), Tangier’s disease (absence of alpha-1- [47 FR 50823, Nov. 9, 1982, as amended at 63 lipoprotein), malnutrition, iron defi- FR 59227, Nov. 3, 1998]

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§ 866.5400 Alpha-globulin immunolog- inherited deficiencies of these plasma ical test system. proteins. (a) Identification. An alpha-globulin (b) Classification. Class I (general con- 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 § 866.9. niques the alpha-globulin (a serum pro- tein) in serum and other body fluids. [47 FR 50823, Nov. 9, 1982, as amended at 65 Measurement of alpha-globulin may FR 2312, Jan. 14, 2000] aid in the diagnosis of inflammatory lesions, infections, severe burns, and a § 866.5430 Beta-2-glycoprotein I immunological test system. variety of other conditions. (b) Classification. Class I (general con- (a) Identification. A beta-2- trols). The device is exempt from the glycoprotein I immunological test sys- premarket notification procedures in tem is a device that consists of the re- subpart E of part 807 of this chapter agents used to measure by subject to § 866.9. immunochemical techniques the beta-2- glycoprotein I (a serum protein) in [47 FR 50823, Nov. 9, 1982, as amended at 65 serum and other body fluids. Measure- FR 2312, Jan. 14, 2000] ment of beta-2-glycoprotein I aids in the diagnosis of an inherited deficiency § 866.5420 Alpha-1-glycoproteins of this serum protein. immunological test system. (b) Classification. Class I (general con- (a) Identification. An alpha-1- trols). The device is exempt from the glycoproteins immunological test sys- premarket notification procedures in tem is a device that consists of the re- subpart E of part 807 of this chapter agents used to measure by subject to § 866.9. immunochemical techniques alpha-1- [47 FR 50823, Nov. 9, 1982, as amended at 65 glycoproteins (a group of plasma pro- FR 2312, Jan. 14, 2000] teins found in the alpha-1 group when subjected to electrophoresis) in serum § 866.5440 Beta-2-glycoprotein III and other body fluids. Measurement of immunological test system. specific alpha-1-glycoproteins may aid (a) Identification. A beta-2- in the diagnosis of collagen (connective glycoprotein III immunological test tissue) disorders, tuberculosis, infec- system is a device that consists of the tions, extensive malignancy, and diabe- reagents used to measure by tes. immunochemical techniques the beta-2- (b) Classification. Class I (general con- glycoprotein III (a serum protein) in trols). The device is exempt from the serum and other body fluids. Measure- premarket notification procedures in ment of beta-2-glycoprotein III aids in subpart E of part 807 of this chapter the diagnosis of an inherited deficiency subject to § 866.9. of this serum protein and a variety of [47 FR 50823, Nov. 9, 1982, as amended at 65 other conditions. FR 2312, Jan. 14, 2000] (b) Classification. Class I (general con- trols). The device is exempt from the § 866.5425 Alpha-2-glycoproteins premarket notification procedures in immunological test system. subpart E of part 807 of this chapter (a) Identification. An alpha-2- subject to § 866.9. glycoproteins immunolgical test sys- [47 FR 50823, Nov. 9, 1982, as amended at 65 tem is a device that consists of the re- FR 2312, Jan. 14, 2000] agents used to measure by immunochemical techniques the alpha- § 866.5460 immunological 2-glycoproteins (a group of plasma pro- test system. teins found in the alpha-2 group when (a) Identification. A haptoglobin subjected to electrophoresis) in serum immunological test system is a device and other body fluids. Measurement of that consists of the reagents used to alpha-2-glycoproteins aids in the diag- measure by immunochemical tech- nosis of some cancers and genetically niques the haptoglobin (a protein that

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binds hemoglobin, the oxygen-carrying in subpart E of part 807 of this chapter pigment in red blood cells) in serum. subject to § 866.9. Measurement of haptoglobin may aid [47 FR 50823, Nov. 9, 1982, as amended at 63 in the diagnosis of hemolytic diseases FR 59227, Nov. 3, 1998] (diseases in which the red blood cells rupture and release hemoglobin) re- § 866.5500 Hypersensitivity pneumo- lated to the formation of hemoglobin- nitis immunological test system. haptoglobin complexes and certain kid- (a) Identification. A hypersensitivity ney diseases. pneumonitis immunological test sys- (b) Classification. Class II (special tem is a device that consists of the re- controls). The device is exempt from agents used to measure by the premarket notification procedures immunochemical techniques the in subpart E of part 807 of this chapter immunoglobulin antibodies in serum subject to § 866.9. which react specifically with organic dust derived from fungal or animal pro- [47 FR 50823, Nov. 9, 1982, as amended at 63 tein sources. When these antibodies FR 59227, Nov. 3, 1998] react with such dusts in the lung, im- mune complexes precipitate and trig- § 866.5470 Hemoglobin immunological test system. ger an inflammatory reaction (hyper- sensitivity pneumonitis). Measurement (a) Indentification. A hemoglobin of these immunoglobulin G antibodies immunological test system is a device aids in the diagnosis of hyper- that consists of the reagents used to sensitivity pneumonitis and other al- measure by immunochemical tech- lergic respiratory disorders. niques the different types of free hemo- (b) Classification. Class II (perform- globin (the oxygen-carrying pigment in ance standards). red blood cells) in blood, urine, plasma, or other body fluids. Measurements of § 866.5510 Immunoglobulins A, G, M, D, free hemoglobin aid in the diagnosis of and E immunological test system. various hematologic disorders, such as (a) Identification. An sickle cell anemia, Fanconi’s anemia (a immunoglobulins A, G, M, D, and E rare inherited disease), aplastic anemia immunological test system is a device (bone marrow does not produce enough that consists of the reagents used to blood cells), and leukemia (cancer of measure by immunochemical tech- the blood-forming organs). niques the immunoglobulins A, G, M, (b) Classification. Class II (perform- D, an E (serum antibodies) in serum. ance standards). Measurement of these immunoglobulins aids in the diagnosis § 866.5490 immunological of abnormal protein metabolism and test system. the body’s lack of ability to resist in- fectious agents. (a) Indentification. A hemopexin (b) Classification. Class II (perform- immunological test system is a device ance standards). that consists of the reagents used to measure by immunochemical tech- § 866.5520 Immunoglobulin G (Fab niques the hemopexin (a serum protein fragment specific) immunological that binds heme, a component of hemo- test system. globin) in serum. Measurement of (a) Identification. An immunoglobulin hemopexin aids in the diagnosis of var- G (Fab fragment specific) immunolog- ious hematologic disorders, such as he- ical test system is a device that con- molytic anemia (anemia due to short- sists of the reagents used to measure ened in vivo survival of mature red by immunochemical techniques the blood cells and inability of the bone Fab antigen-binding fragment result- marrow to compensate for their de- ing from breakdown of creased life span) and sickle cell ane- immunoglobulin G antibodies in urine, mia. serum, and other body fluids. Measure- (b) Classification. Class II (special ment of Fab fragments of controls). The device is exempt from immunoglobulin G aids in the diag- the premarket notification procedures nosis of lymphoproliferative disorders,

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such as multiple myeloma (tumor of premarket notification procedures in bone marrow cells), Waldenstrom’s subpart E of part 807 of this chapter macroglobulinemia (increased subject to the limitations in § 866.9. immunoglobulin production by the [47 FR 50823, Nov. 9, 1982, as amended at 59 spleen and bone marrow cells), and FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, lymphoma (tumor of the lymphoid tis- 2001] sues). (b) Classification. Class I (general con- § 866.5550 Immunoglobulin (light trols). The device is exempt from the chain specific) immunological test premarket notification procedures in system. subpart E of part 807 of this chapter (a) Identification. An immunoglobulin subject to the limitations in § 866.9. (light chain specific) immunological [47 FR 50823, Nov. 9, 1982, as amended at 61 test system is a device that consists of FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, the reagents used to measure by 2001] immunochemical techniques both kappa and lambda types of light chain § 866.5530 Immunoglobulin G (Fc frag- portions of immunoglobulin molecules ment specific) immunological test in serum, other body fluids, and tis- system. sues. In some disease states, an excess (a) Identification. An immunoglobulin of light chains are produced by the G (Fc fragment specific) immunolog- antibody-forming cells. These free ical test system is a device that con- light chains, unassociated with gamma sists of the reagents used to measure globulin molecules, can be found in a by immunochemical techniques the Fc patient’s body fluids and tissues. Meas- (carbohydrate containing) fragment of urement of the various amounts of the immunoglobulin G (resulting from different types of light chains aids in breakdown of immunoglobulin G anti- the diagnosis of multiple myeloma bodies) in urine, serum, and other body (cancer of antibody-forming cells), fluids. Measurement of lymphocytic neoplasms (cancer of immunoglobulin G Fc fragments aids lymphoid tissue), Waldenstrom’s in the diagnosis of plasma cell anti- macroglobulinemia (increased produc- body-forming abnormalities, e.g., tion of large immunoglobulins), and gamma heavy chain disease. connective tissue diseases such as (b) Classification. Class I (general con- rheumatoid arthritis or systemic lupus trols). The device is exempt from the erythematosus. premarket notification procedures in (b) Classification. Class II (perform- subpart E of part 807 of this chapter ance standards). subject to the limitations in § 866.9. § 866.5560 Lactic dehydrogenase [47 FR 50823, Nov. 9, 1982, as amended at 61 immunological test system. FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] (a) Identification. A lactic dehydro- genase immunological test system is a § 866.5540 Immunoglobulin G (Fd frag- device that consists of the reagents ment specific) immunological test used to measure by immunochemical system. techniques the activity of the lactic (a) Identification. An immunoglobulin dehydrogenase enzyme in serum. In- G (Fd fragment specific) immunolog- creased levels of lactic dehydrogenase ical test system is a device that con- are found in a variety of conditions, in- sists of the reagents used to measure cluding megaloblastic anemia (de- by immunochemical techniques the crease in the number of mature red amino terminal (antigen-binding) end blood cells), myocardial infarction (Fd fragment) of the heavy chain (a (heart disease), and some forms of leu- subunit) of the immunoglobulin anti- kemia (cancer of the blood-forming or- body molecule in serum. Measurement gans). However, the diagnostic useful- of immunoglobulin G Fd fragments ness of this device is limited because of aids in the diagnosis of plasma anti- the many conditions known to cause body-forming cell abnormalities. increased lactic dehydrogenase levels. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the

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premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 866.9. subject to § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 65 [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000] FR 2312, Jan. 14, 2000] § 866.5600 Low-density lipoprotein immunological test system. § 866.5570 immunological test system. (a) Identification. A low-density lipoprotein immunological test system (a) Identification. A lactoferrin is a device that consists of the reagents immunological test system is a device used to measure by immunochemical that consists of the reagents used to techniques the low-density lipoprotein measure by immunochemical tech- in serum and other body fluids. Meas- niques the lactoferrin (an iron-binding urement of low-density lipoprotein in protein with the ability to inhibit the serum may aid in the diagnosis of dis- growth of bacteria) in serum, breast orders of lipid (fat) metabolism and milk, other body fluids, and tissues. help to identify young persons at risk Measurement of lactoferrin may aid in from cardiovascular diseases. the diagnosis of an inherited deficiency (b) Classification. Class II (perform- of this protein. ance standards). (b) Classification. Class I (general con- trols). The device is exempt from the § 866.5620 Alpha-2- premarket notification procedures in immunological test system. subpart E of part 807 of this chapter (a) Identification. An alpha-2- subject to § 866.9. macroglobulin immunological test sys- tem is a device that consists of the re- [47 FR 50823, Nov. 9, 1982, as amended at 65 agents used to measure by FR 2312, Jan. 14, 2000] immunochemical techniques the alpha- 2-macroglobulin (a serum protein) in § 866.5580 Alpha-1-lipoprotein immun- plasma. Measurement of alpha-2- ological test system. macroglobulin may aid in the diagnosis (a) Identification. An alpha-1- of blood-clotting or clot lysis disorders. lipoprotein immunological test system (b) Classification. Class II (perform- is a device that consists of the reagents ance standards). used to measure by immunochemical techniques the alpha-1-lipoprotein § 866.5630 Beta-2- (high-density lipoprotein) in serum and immunological test system. plasma. Measurement of alpha-1- (a) Identification. A beta-2-microglob- lipoprotein may aid in the diagnosis of ulin immunological test system is a de- Tangier disease (a hereditary disorder vice that consists of the reagents used of fat metabolism). to measure by immunochemical tech- (b) Classification. Class II (perform- niques beta-2-microglobulin (a protein ance standards). molecule) in serum, urine, and other body fluids. Measurement of beta-2- § 866.5590 Lipoprotein X immunolog- microglobulin aids in the diagnosis of ical test system. active rheumatoid arthritis and kidney disease. (a) Identification. A lipoprotein X (b) Classification. Class II (perform- immunological test system is a device ance standards). that consists of the reagents used to measure by immunochemical tech- § 866.5640 Infectious mononucleosis niques lipoprotein X (a high-density immunological test system. lipoprotein) in serum and other body (a) Identification. An infectious mono- fluids. Measurement of lipoprotein X nucleosis immunological test system is aids in the diagnosis of obstructive a device that consists of the reagents liver disease. used to measure by immunochemical (b) Classification. Class I (general con- techniques heterophile antibodies fre- trols). The device is exempt from the quently associated with infectious premarket notification procedures in mononucleosis in serum, plasma, and

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other body fluids. Measurements of subpart E of part 807 of this chapter these antibodies aid in the diagnosis of subject to the limitations in § 866.9. infectious mononucleosis. [47 FR 50823, Nov. 9, 1982, as amended at 59 (b) Classification. Class II (perform- FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, ance standards). 2001] [47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982] § 866.5715 Plasminogen immunological test system. § 866.5660 Multiple autoantibodies (a) Identification. A plasminogen immunological test system. immunological test system is a device (a) Identification. A multiple that consists of the reagents used to autoantibodies immunological test sys- measure by immunochemical tech- tem is a device that consists of the re- niques the plasminogen (an inactive agents used to measure by substance from which , a blood- immunochemical techniques the clotting factor, is formed) in serum, autoantibodies (antibodies produced other body fluids, and tissues. Measure- against the body’s own tissues) in ment of plasminogen levels may aid in serum and other body fluids. Measure- the diagnosis of fibrinolytic (blood- ment of multiple autoantibodies aids clotting) disorders. in the diagnosis of autoimmune dis- (b) Classification. Class I (general con- orders (disease produced when the trols). The device is exempt from the body’s own tissues are injured by premarket notification procedures in autoantibodies). subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to § 866.9. ance standards). [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000] § 866.5680 Myoglobin immunological test system. § 866.5735 Prothrombin immunological (a) Identification. A myoglobin test system. immunological test system is a device (a) Identification. A prothrombin that consists of the reagents used to immunological test system is a device measure by immunochemical tech- that consists of the reagents used to niques the myoglobin (an oxygen stor- measure by immunochemical tech- age protein found in muscle) in serum niques the prothrombin (clotting factor and other body fluids. Measurement of II) in serum. Measurements of the myoglobin aids in the rapid diagnosis amount of antigenically competent of heart or renal disease. (ability to react with protein anti- (b) Classification. Class II (perform- bodies) prothrombin aid in the diag- ance standards). nosis of blood-clotting disorders. (b) Classification. Class I (general con- § 866.5700 Whole human plasma or trols). The device is exempt from the serum immunological test system. premarket notification procedures in (a) Identification. A whole human subpart E of part 807 of this chapter plasma or serum immunological test subject to § 866.9. This exemption does system is a device that consists of re- not apply to multipurpose systems for agents used to measure by in vitro coagulation studies classified immunochemical techniques the pro- under § 864.5425 of this chapter or pro- teins in plasma or serum. Measure- thrombin time tests classified under ments of proteins in plasma or serum § 864.7750 of this chapter. aid in the diagnosis of any disease con- [47 FR 50823, Nov. 9, 1982, as amended at 65 cerned with abnormal levels of plasma FR 2313, Jan. 14, 2000] or serum proteins, e.g., agammaglobu- linemia, allergies, multiple myeloma, § 866.5750 Radioallergosorbent (RAST) rheumatoid vasculitis, or hereditary immunological test system. angioneurotic edema. (a) Identification. A (b) Classification. Class I (general con- radioallergosorbent immunological trols). The device is exempt from the test system is a device that consists of premarket notification procedures in the reagents used to measure by

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immunochemical techniques the aller- (b) Classification. Class II (special gen antibodies (antibodies which cause controls). The special control is FDA’s an allergic reaction) specific for a ‘‘Guidance for Industry and FDA Re- given allergen. Measurement of specific viewers: Class II Special Control Guid- allergen antibodies may aid in the di- ance Document for Anti-Saccharomyces agnosis of asthma, allergies, and other cerevisiae (S. cerevisiae) Antibody pulmonary disorders. (ASCA) Premarket Notifications.’’ (b) Classification. Class II (perform- [65 FR 70307, Nov. 22, 2000] ance standards). § 866.5800 Seminal fluid (sperm) § 866.5765 Retinol-binding protein immunological test system. immunological test system. (a) Identification. A seminal fluid (a) Identification. A retinol-binding (sperm) immunological test system is a protein immunological test system is a device that consists of the reagents device that consists of the reagents used for legal purposes to identify and used to measure by immunochemical differentiate animal and human semen. techniques the retinol-binding protein The test results may be used as court that binds and transports vitamin A in evidence in alleged instances of rape serum and urine. Measurement of this and other sex-related crimes. protein may aid in the diagnosis of kid- (b) Classification. Class I (general con- ney disease and in monitoring patients trols). The device is exempt from the with kidney transplants. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to the limitations in § 866.9. premarket notification procedures in subpart E of part 807 of this chapter [54 FR 25047, June 12, 1989, as amended at 66 subject to § 866.9. FR 38793, July 25, 2001] [47 FR 50823, Nov. 9, 1982, as amended at 65 § 866.5820 Systemic lupus FR 2313, Jan. 14, 2000] erythematosus immunological test system. § 866.5775 Rheumatoid factor immuno- (a) Identification. A systemic lupus logical test system. erythematosus (SLE) immunological (a) Identification. A rheumatoid factor test system is a device that consists of immunological test system is a device the reagents used to measure by that consists of the reagents used to immunochemical techniques the measure by immunochemical tech- autoimmune antibodies in serum and niques the rheumatoid factor (anti- other body fluids that react with cel- bodies to immunoglobulins) in serum, lular nuclear double-stranded other body fluids, and tissues. Measure- deoxyribonucleic acid (DNA) or other ment of rheumatoid factor may aid in nuclear constituents that are specifi- the diagnosis of rheumatoid arthritis. cally diagnostic of SLE. Measurement (b) Classification. Class II (perform- of nuclear double-stranded DNA anti- ance standards). bodies aids in the diagnosis of SLE (a multisystem autoimmune disease in § 866.5785 Anti-Saccharomyces which tissues are attacked by the per- cerevisiae (S. cerevisiae) antibody son’s own antibodies). (ASCA) test systems. (b) Classification. Class II (perform- (a) Identification. The Anti-Saccharo- ance standards). myces cerevisiae (S. cerevisiae) antibody (ASCA) test system is an in vitro diag- § 866.5860 Total spinal fluid immuno- nostic device that consists of the re- logical test system. agents used to measure, by (a) Identification. A total spinal fluid immunochemical techniques, anti- immunological test system is a device bodies to S. cerevisiae (baker’s or brew- that consists of the reagents used to er’s yeast) in human serum or plasma. measure by immunochemical tech- Detection of S. cerevisiae antibodies niques the total protein in cerebro- may aid in the diagnosis of Crohn’s dis- spinal fluid. Measurement of spinal ease. fluid proteins may aid in the diagnosis

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of multiple sclerosis and other diseases may aid in the diagnosis of acute bac- of the nervous system. terial infection and inflammation. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 866.9. subject to § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 61 [47 FR 50823, Nov. 9, 1982, as amended at 53 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, FR 11253, Apr. 6, 1988; 65 FR 2313, Jan. 14, 2001] 2000]

§ 866.5870 Thyroid autoantibody immunological test system. Subpart G—Tumor Associated Antigen immunological Test (a) Identification. A thyroid Systems autoantibody immunological test sys- tem is a device that consists of the re- § 866.6010 Tumor-associated antigen agents used to measure by immunological test system. immunochemical techniques the thy- (a) Identification. A tumor-associated roid autoantibodies (antibodies pro- antigen immunological test system is a duced against the body’s own tissues). device that consists of reagents used to Measurement of thyroid autoantibodies qualitatively or quantitatively meas- may aid in the diagnosis of certain thy- ure, by immunochemical techniques, roid disorders, such as Hashimoto’s dis- tumor-associated antigens in serum, ease (chronic lymphocytic thyroiditis), plasma, urine, or other body fluids. nontoxic goiter (enlargement of thy- This device is intended as an aid in roid gland), Grave’s disease (enlarge- monitoring patients for disease ment of the thyroid gland with protru- progress or response to therapy or for sion of the eyeballs), and cancer of the the detection of recurrent or residual thyroid. disease. (b) Classification. Class II (perform- (b) Classification. Class II (special ance standards). controls). Tumor markers must comply § 866.5880 Transferrin immunological with the following special controls: (1) test system. A guidance document entitled ‘‘Guid- ance Document for the Submission of (a) Identification. A transferrin Tumor Associated Antigen Premarket immunological test system is a device Notifications (510(k)s) to FDA,’’ and (2) that consists of the reagents used to voluntary assay performance standards measure by immunochemical tech- issued by the National Committee on niques the transferrin (an iron-binding Clinical Laboratory Standards. and transporting serum protein) in serum, plasma, and other body fluids. [62 FR 66005, Dec. 17, 1997] Measurement of transferrin levels aids in the diagnosis of malnutrition, acute PART 868—ANESTHESIOLOGY inflammation, infection, and red blood DEVICES cell disorders, such as iron deficiency anemia. Subpart A—General Provisions (b) Classification. Class II (perform- ance standards). Sec. 868.1 Scope. § 866.5890 Inter-alpha trypsin inhibitor 868.3 Effective dates of requirement for pre- immunological test system. market approval. 868.9 Limitations of exemptions from sec- (a) Identification. An inter-alpha tion 510(k) of the Federal Food, Drug, trypsin inhibitor immunological test and Cosmetic Act (the act). system is a device that consists of the reagents used to measure by Subpart B—Diagnostic Devices immunochemical techniques the inter- 868.1030 Manual algesimeter. alpha trypsin inhibitor (a protein) in 868.1040 Powered algesimeter. serum and other body fluids. Measure- 868.1075 Argon gas analyzer. ment of inter-alpha trypsin inhibitor 868.1100 Arterial blood sampling kit.

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