Food and Drug Administration, HHS § 866.5065

subpart E of part 807 of this chapter used while measuring various kinds of, subject to the limitations in § 866.9. or parts of, protein molecules by var- ious immunochemical techniques, such [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, as immunoelectrophoresis, immuno- 2001] diffusion, or chromatography. (b) Classification. Class I (general con- § 866.4800 Radial immunodiffusion trols). The device is exempt from the plate. premarket notification procedures in (a) Identification. A radial subpart E of part 807 of this chapter immunodiffusion plate for clinical use subject to the limitations in § 866.9. is a device that consists of a plastic [47 FR 50823, Nov. 9, 1982, as amended at 54 plate to which agar gel containing FR 25047, June 12, 1989; 66 FR 38792, July 25, antiserum is added. In radial 2001] immunodiffusion, antigens migrate through gel which originally contains Subpart F—Immunological Test specific . As the reagents Systems come in contact with each other, they combine to form a precipitate that is § 866.5040 immunological test trapped in the gel matrix and immo- system. bilized. (a) Identification. An albumin immun- (b) Classification. Class I (general con- ological test system is a device that trols). The device is exempt from the consists of the reagents used to meas- premarket notification procedures in ure by immunochemical techniques the subpart E of part 807 of this chapter albumin (a plasma protein) in serum subject to the limitations in § 866.9. and other body fluids. Measurement of [47 FR 50823, Nov. 9, 1982, as amended at 66 albumin aids in the diagnosis of kidney FR 38792, July 25, 2001] and intestinal diseases. (b) Classification. Class II (special § 866.4830 Rocket controls). The device is exempt from immunoelectrophoresis equipment. the premarket notification procedures (a) Identification. Rocket in subpart E of part 807 of this chapter immunoelectrophoresis equipment for subject to § 866.9. clinical use is a device used to perform [47 FR 50823, Nov. 9, 1982, as amended at 63 a specific test on proteins by using a FR 59227, Nov. 3, 1998] procedure called rocket immunoelectrophoresis. In this proce- § 866.5060 Prealbumin immunological dure, an electric current causes the test system. protein in solution to migrate through (a) Identification. A prealbumin agar gel containing specific antisera. immunological test system is a device The protein precipitates with the that consists of the reagents used to antisera in a rocket-shaped pattern, measure by immunochemical tech- giving the name to the device. The niques the prealbumin (a plasma pro- height of the peak (or the area under tein) in serum and other body fluids. the peak) is proportional to the con- Measurement of prealbumin levels in centration of the protein. serum may aid in the assessment of the (b) Classification. Class I (general con- patient’s nutritional status. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to the limitations in § 866.9. subpart E of part 807 of this chapter [47 FR 50823, Nov. 9, 1982, as amended at 54 subject to § 866.9. FR 25047, June 12, 1989; 66 FR 38792, July 25, [47 FR 50823, Nov. 9, 1982, as amended at 65 2001] FR 2312, Jan. 14, 2000]

§ 866.4900 Support gel. § 866.5065 Human allotypic marker (a) Identification. A support gel for immunological test system. clinical use is a device that consists of (a) Identification. A human allotypic an agar or agarose preparation that is marker immunological test system is a

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device that consists of the reagents stituents (molecules present in the nu- used to identify by immunochemical cleus of a cell, such as ribonucleic acid, techniques the inherited human pro- deoxyribonucleic acid, or nuclear pro- tein allotypic markers (such as nGm, teins). The measurements aid in the di- nA2 m, and Km allotypes) in serum and 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 subpart E of part 807 of this chapter with inflammation of the eye, eyelid, subject to § 866.9. and salivary glands), and systemic scle- rosis (chronic hardening and shrinking [47 FR 50823, Nov. 9, 1982, as amended at 65 of many body tissues). FR 2312, Jan. 14, 2000] (b) Classification. Class II (perform- § 866.5080 Alpha-1-antichymotrypsin ance standards). immunological test system. § 866.5110 Antiparietal (a) Identification. An alpha-1- immunological test system. antichymotrypsin immunological test system is a device that consists of the (a) Identification. An antiparietal reagents used to measure by antibody immunological test system is immunochemical techniques alpha-1- a device that consists of the reagents antichymotrypsin (a protein) in serum, used to measure by immunochemical other body fluids, and tissues. Alpha-1- techniques the specific antibody for antichymotrypsin helps protect tissues gastric parietal cells in serum and against proteolytic (protein-splitting) other body fluids. Gastric parietal cells enzymes released during infection. are those cells located in the stomach (b) Classification. Class II (perform- that produce a protein that enables vi- ance standards). tamin B12 to be absorbed by the body. The measurements aid in the diagnosis § 866.5090 Antimitochondrial antibody immunological test system. of vitamin B12 deficiency (or pernicious anemia), atrophic gastritis (inflamma- (a) An Identification. tion of the stomach), and autoimmune antimitochondrial antibody immuno- connective tissue diseases (diseases re- logical test system is a device that sulting when the body produces anti- consists of the reagents used to meas- ure by immunochemical techniques the bodies against its own tissues). antimitochondrial antibodies in human (b) Classification. Class II (perform- serum. The measurements aid in the ance standards). diagnosis of diseases that produce a spectrum of autoantibodies (antibodies § 866.5120 Antismooth muscle antibody produced against the body’s own tis- immunological test system. sue), such as primary biliary cirrhosis (a) Identification. An antismooth mus- (degeneration of liver tissue) and cle antibody immunological test sys- chronic active hepatitis (inflammation tem is a device that consists of the re- of the liver). agents used to measure by (b) Classification. Class II (perform- immunochemical techniques the ance standards). antismooth muscle antibodies (anti- bodies to nonstriated, involuntary § 866.5100 Antinuclear antibody immunological test system. muscle) in serum. The measurements aid in the diagnosis of chronic hepa- (a) Identification. An antinuclear titis (inflammation of the liver) and antibody immunological test system is autoimmune connective tissue diseases a device that consists of the reagents (diseases resulting from antibodies pro- used to measure by immunochemical duced against the body’s own tissues). techniques the autoimmune antibodies in serum, other body fluids, and tissues (b) Classification Class II (perform- that react with cellular nuclear con- ance standards).

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§ 866.5130 Alpha-1-antitrypsin immun- beta (serum protein) in serum ological test system. and other body fluids. Beta- (a) Identification. An alpha-1- proteins include beta-lipoprotein, antitrypsin immunological test system , glycoproteins, and com- is 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 con- plasma 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 § 866.5150 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 tech- teins immunological test system is a niques the breast milk proteins. device that consists of the reagents (b) Classification. Class I (general con- used to measure by immunochemical trols). The device is exempt from the techniques the Bence-Jones proteins in premarket notification procedures in urine and plasma. Immunoglobulin subpart E of part 807 of this chapter molecules normally consist of pairs of subject to the limitations in § 866.9. polypeptide chains (subunits) of un- equal size (light chains and heavy [47 FR 50823, Nov. 9, 1982, as amended at 59 chains) bound together by several di- FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, sulfide bridges. In some cancerous con- 2001] ditions, there is a proliferation of one § 866.5200 Carbonic anhydrase B and plasma cell (antibody-producing cell) C immunological test system. with excess production of light chains of one specific kind (monoclonal light (a) Identification. A carbonic anhy- chains). These free homogeneous light drase B and C immunological test sys- chains not associated with an tem is a device that consists of the re- immunoglobulin molecule can be found agents used to measure by in urine and plasma, and have been immunochemical techniques specific called Bence-Jones proteins. Measure- carbonic anhydrase protein molecules ment of Bence-Jones proteins and de- in serum and other body fluids. Meas- termination that they are monoclonal urements of carbonic anhydrase B and aid in the diagnosis of multiple C aid in the diagnosis of abnormal he- myeloma (malignant proliferation of moglobin metabolism. plasma cells), Waldenstrom’s (b) Classification. Class I (general con- macroglobulinemia (increased produc- trols). The device is exempt from the tion of large immunoglobulins by premarket notification procedures in spleen and bone marrow cells), leu- subpart E of part 807 of this chapter kemia (cancer of the blood-forming or- subject to § 866.9. gans), and lymphoma (cancer of the [47 FR 50823, Nov. 9, 1982, as amended at 65 lymphoid tissue). FR 2312, Jan. 14, 2000] (b) Classification. Class II (perform- ance standards). § 866.5210 immunolog- ical test system. § 866.5160 Beta-globulin immunolog- (a) Identification. A ceruloplasmin ical test system. immunological test system is a device (a) Identification. A beta-globulin that consists of the reagents used to immunological test system is a device measure by immunochemical tech- that consists of reagents used to meas- niques the ceruloplasmin (copper- ure by immunochemical techniques transporting serum protein) in serum,

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other body fluids, or tissues. Measure- a device that consists of the reagents ments of ceruloplasmin aid in the diag- used to measure by immunochemical nosis of copper metabolism disorders. techniques complement components (b) Classification. Class II (perform- C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and ance standards). C9, in serum, other body fluids, and tis- sues. Complement is a group of serum § 866.5220 Cohn fraction II immunolog- ical test system. proteins which destroy infectious agents. Measurements of these proteins (a) Identification. A Cohn fraction II aids in the diagnosis of immunologic immunological test system is a device disorders, especially those associated that consists of the reagents that con- tain or are used to measure that frac- with deficiencies of complement com- tion of plasma containing protein ponents. gamma globulins, predominantly of the (b) Classification. Class II (perform- IgG class. The device may be used as a ance standards). coprecipitant in radioimmunoassay [47 FR 50823, Nov. 9, 1982, as amended at 53 methods, as raw material for the puri- FR 11253, Apr. 6, 1988] fication of IgG subclasses, and to re-

duce nonspecific adsorption of plasma § 866.5250 Complement C1 inhibitor proteins in immunoassay techniques. (inactivator) immunological test Measurement of these proteins aids in system. the diagnosis of any disease concerned (a) Identification. A complement C with abnormal levels of IgG gamma 1 globulins such as agammaglobulinemia inhibitor (inactivator) immunological or multiple myeloma. test system is a device that consists of (b) Classification. Class I (general con- the reagents used to measure by trols). The device is exempt from the immunochemical techniques the com- premarket notification procedures in plement C1 inhibitor (a plasma protein) subpart E of part 807 of this chapter in serum. Complement C1 inhibitor oc- subject to the limitations in § 866.9. curs normally in plasma and blocks the action of the C component of com- [47 FR 50823, Nov. 9, 1982, as amended at 59 1 FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, plement (a group of serum proteins 2001] which destroy infectious agents). Meas- urement of complement C1 inhibitor § 866.5230 Colostrum immunological aids in the diagnosis of hereditary test system. angioneurotic edema (increased blood (a) Identification. A colostrum vessel permeability causing swelling of immunological test system is a device tissues) and a rare form of angioedema that consists of the reagents used to associated with lymphoma (lymph node measure by immunochemical tech- cancer). niques the specific proteins in colos- (b) Classification. Class II (perform- trum. Colostrum is a substance ex- ance standards). creted by the mammary glands during

pregnancy and until production of § 866.5260 Complement C3b inactivator breast milk begins 1 to 5 days after immunological test system. childbirth. (a) Identification. A complement C (b) Classification. Class I (general con- 3b trols). The device is exempt from the inactivator immunological test system premarket notification procedures in is a device that consists of the reagents subpart E of part 807 of this chapter used to measure by immunochemical subject to the limitations in § 866.9. techniques the complement C3b inactivator (a plasma protein) in [47 FR 50823, Nov. 9, 1982, as amended at 59 serum. Complement is a group of serum FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, 2001] proteins that destroy infectious agents. Measurement of complement C3b § 866.5240 Complement components inactivator aids in the diagnosis of in- immunological test system. herited antibody dysfunction. (a) Identification. A complement com- (b) Classification. Class II (perform- ponents immunological test system is ance standards).

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§ 866.5270 C-reactive protein immuno- that consists of the reagents used to logical test system. measure by immunochemical tech- (a) Identification. A C-reactive protein niques the factor XIII (a bloodclotting immunological test system is a device factor), in platelets (A) or serum (S). that consists of the reagents used to Measurements of factor XIII, A, S, aid measure by immunochemical tech- in the diagnosis and treatment of cer- niques the C-reactive protein in serum tain bleeding disorders resulting from a and other body fluids. Measurement of deficiency of this factor. C-reactive protein aids in evaluation of (b) Classification. Class I (general con- the amount of injury to body tissues. trols). The device is exempt from the (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 factor B immuno- not apply to factor deficiency tests logical test system. classified under § 864.7290 of this chap- (a) Identification. A properdin factor ter. B immunological test system is a de- [47 FR 50823, Nov. 9, 1982, as amended at 65 vice that consists of the reagents used FR 2312, Jan. 14, 2000] to measure by immunochemical tech- niques properdin factor B in serum and § 866.5340 Ferritin immunological test other body fluids. The deposition of system. properdin factor B in body tissues or a (a) Identification. A ferritin immuno- corresponding depression in the logical test system is a device that amount of properdin factor B in serum consists of the reagents used to meas- and other body fluids is evidence of the ure by immunochemical techniques the involvement of the alternative to the ferritin (an iron-storing protein) in classical pathway of activation of com- serum and other body fluids. Measure- plement (a group of plasma proteins ments of ferritin aid in the diagnosis of which cause the destruction of cells diseases affecting iron metabolism, which are foreign to the body). Meas- such as hemochromatosis (iron over- urement of properdin factor B aids in load) and iron deficiency amemia. the diagnosis of several kidney dis- (b) Classification. Class II (perform- eases, e.g., chronic glomerulonephritis ance standards). (inflammation of the glomeruli of the kidney), lupus nephritis (kidney dis- § 866.5350 Fibrinopeptide A immuno- ease associated with a multisystem logical test system. autoimmune disease, systemic lupus (a) Identification. A fibrinopeptide A erythematosus), as well as several skin immunological test system is a device diseases, e.g., dermititis herpetiformis that consists of the reagents used to (presence of vesicles on the skin that measure by immunochemical tech- burn and itch), and pemphigus vulgaris niques the fibrinopeptide A (a blood- (large vesicles on the skin). Other dis- clotting factor) in plasma and other eases in which the alternate pathway body fluids. Measurement of of complement activation has been im- fibrinopeptide A may aid in the diag- plicated include rheumatoid arthritis, nosis and treatment of certain blood- sickle cell anemia, and gram-negative clotting disorders. bacteremia. (b) Classification. Class II (perform- (b) Classification. Class II (special ance standards). controls). The device is exempt from the premarket notification procedures § 866.5360 Cohn fraction IV immuno- in subpart E of part 807 of this chapter logical test system. subject to § 866.9. (a) Identification. A Cohn fraction IV [47 FR 50823, Nov. 9, 1982, as amended at 63 immunological test system is a device FR 59227, Nov. 3, 1998] that consists of or measures that frac- tion of plasma proteins, predominantly § 866.5330 Factor XIII, A, S, immuno- alpha- and beta- globulins, used as a logical test system. raw material for the production of pure (a) Identification. A factor XIII, A, S, alpha- or beta- globulins. Measurement immunological test system is a device of specific alpha- or beta- globulins aids

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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), [47 FR 50823, Nov. 9, 1982, as amended at 63 Tangier’s disease (absence of alpha-1- FR 59227, Nov. 3, 1998] lipoprotein), malnutrition, iron defi- ciency anemia, red blood cell disorders, § 866.5400 Alpha-globulin immunolog- and kidney disease. 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 the limitations in § 866.9. niques the alpha-globulin (a serum pro- tein) in serum and other body fluids. [47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, Measurement of alpha-globulin may 1982, as amended at 59 FR 63007, Dec. 7, 1994; aid in the diagnosis of inflammatory 66 FR 38793, July 25, 2001] lesions, infections, severe burns, and a variety of other conditions. § 866.5370 Cohn fraction V immunolog- (b) Classification. Class I (general con- ical test system. trols). The device is exempt from the (a) Identification. A Cohn fraction V premarket notification procedures in immunological test system is a device subpart E of part 807 of this chapter that consists of or measures that frac- subject to § 866.9. tion of plasma containing predomi- [47 FR 50823, Nov. 9, 1982, as amended at 65 nantly albumin (a plasma protein). FR 2312, Jan. 14, 2000] This test aids in the diagnosis of dis- eases where albumin levels may be de- § 866.5420 Alpha-1-glycoproteins pressed, e.g., nephrosis (disease of the immunological test system. kidney), proteinuria (protein in the (a) Identification. An alpha-1- urine), gastroenteropathy (disease of glycoproteins immunological test sys- the stomach and small intestine), rheu- tem is a device that consists of the re- matoid arthritis, and viral hepatitis. agents used to measure by (b) Classification. Class I (general con- immunochemical techniques alpha-1- trols). The device is exempt from the glycoproteins (a group of plasma pro- premarket notification procedures in teins found in the alpha-1 group when subpart E of part 807 of this chapter subjected to electrophoresis) in serum subject to the limitations in § 866.9. and other body fluids. Measurement of specific alpha-1-glycoproteins may aid [47 FR 50823, Nov. 9, 1982, as amended at 59 in the diagnosis of collagen (connective FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, tissue) disorders, tuberculosis, infec- 2001] tions, extensive malignancy, and diabe- tes. § 866.5380 Free secretory component immunological test system. (b) Classification. Class I (general con- 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 § 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. § 866.5425 Alpha-2-glycoproteins Measurement of free secretory compo- immunological test system. nent (protein molecules) aids in the di- (a) Identification. An alpha-2- agnosis or repetitive lung infections glycoproteins immunolgical test sys- and other hypogammaglobulinemic tem is a device that consists of the re- conditions (low antibody levels). agents used to measure by (b) Classification. Class II (special immunochemical techniques the alpha- controls). The device is exempt from 2-glycoproteins (a group of plasma pro- the premarket notification procedures teins found in the alpha-2 group when

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subjected to electrophoresis) in serum § 866.5460 immunological and other body fluids. Measurement of test system. alpha-2-glycoproteins aids in the diag- (a) Identification. A haptoglobin nosis of some cancers and genetically immunological test system is a device inherited deficiencies of these plasma that consists of the reagents used to proteins. measure by immunochemical tech- (b) Classification. Class I (general con- niques the haptoglobin (a protein that trols). The device is exempt from the binds hemoglobin, the oxygen-carrying premarket notification procedures in pigment in red blood cells) in serum. subpart E of part 807 of this chapter Measurement of haptoglobin may aid subject to § 866.9. in the diagnosis of hemolytic diseases (diseases in which the red blood cells [47 FR 50823, Nov. 9, 1982, as amended at 65 rupture and release hemoglobin) re- FR 2312, Jan. 14, 2000] lated to the formation of hemoglobin- haptoglobin complexes and certain kid- § 866.5430 Beta-2-glycoprotein I ney diseases. immunological test system. (b) Classification. Class II (special (a) Identification. A beta-2- controls). The device is exempt from glycoprotein I immunological test sys- the premarket notification procedures tem is a device that consists of the re- in subpart E of part 807 of this chapter agents used to measure by subject to § 866.9. immunochemical techniques the beta-2- [47 FR 50823, Nov. 9, 1982, as amended at 63 glycoprotein I (a serum protein) in FR 59227, Nov. 3, 1998] serum and other body fluids. Measure- ment of beta-2-glycoprotein I aids in § 866.5470 Hemoglobin immunological the diagnosis of an inherited deficiency test system. of this serum protein. (a) Indentification. A hemoglobin (b) Classification. Class I (general con- immunological test system is a device trols). The device is exempt from the that consists of the reagents used to premarket notification procedures in measure by immunochemical tech- subpart E of part 807 of this chapter niques the different types of free hemo- subject to § 866.9. globin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, [47 FR 50823, Nov. 9, 1982, as amended at 65 or other body fluids. Measurements of FR 2312, Jan. 14, 2000] free hemoglobin aid in the diagnosis of various hematologic disorders, such as § 866.5440 Beta-2-glycoprotein III sickle cell anemia, Fanconi’s anemia (a immunological test system. rare inherited disease), aplastic anemia (a) Identification. A beta-2- (bone marrow does not produce enough glycoprotein III immunological test blood cells), and leukemia (cancer of system is a device that consists of the the blood-forming organs). reagents used to measure by (b) Classification. Class II (perform- immunochemical techniques the beta-2- ance standards). glycoprotein III (a serum protein) in serum and other body fluids. Measure- § 866.5490 immunological ment of beta-2-glycoprotein III aids in test system. the diagnosis of an inherited deficiency (a) Indentification. A hemopexin of this serum protein and a variety of immunological test system is a device other conditions. that consists of the reagents used to (b) Classification. Class I (general con- measure by immunochemical tech- trols). The device is exempt from the niques the hemopexin (a serum protein premarket notification procedures in that binds heme, a component of hemo- globin) in serum. Measurement of subpart E of part 807 of this chapter hemopexin aids in the diagnosis of var- subject to § 866.9. ious hematologic disorders, such as he- [47 FR 50823, Nov. 9, 1982, as amended at 65 molytic anemia (anemia due to short- FR 2312, Jan. 14, 2000] ened in vivo survival of mature red

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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, in subpart E of part 807 of this chapter such as multiple myeloma (tumor of subject to § 866.9. bone marrow cells), Waldenstrom’s macroglobulinemia (increased [47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998] immunoglobulin production by the spleen and bone marrow cells), and § 866.5500 Hypersensitivity pneumo- lymphoma (tumor of the lymphoid tis- nitis immunological test system. sues). (a) Identification. A hypersensitivity (b) Classification. Class I (general con- pneumonitis immunological test sys- trols). The device is exempt from the tem is a device that consists of the re- premarket notification procedures in agents used to measure by subpart E of part 807 of this chapter immunochemical techniques the subject to the limitations in § 866.9. immunoglobulin antibodies in serum [47 FR 50823, Nov. 9, 1982, as amended at 61 which react specifically with organic FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, dust derived from fungal or animal pro- 2001] tein sources. When these antibodies react with such dusts in the lung, im- § 866.5530 Immunoglobulin G (Fc frag- mune complexes precipitate and trig- ment specific) immunological test system. ger an inflammatory reaction (hyper- sensitivity pneumonitis). Measurement (a) Identification. An immunoglobulin of these immunoglobulin G antibodies G (Fc fragment specific) immunolog- aids in the diagnosis of hyper- ical test system is a device that con- sensitivity pneumonitis and other al- sists of the reagents used to measure lergic respiratory disorders. by immunochemical techniques the Fc (b) Classification. Class II (perform- (carbohydrate containing) fragment of ance standards). immunoglobulin G (resulting from breakdown of immunoglobulin G anti- § 866.5510 Immunoglobulins A, G, M, D, bodies) in urine, serum, and other body and E immunological test system. fluids. Measurement of (a) Identification. An immunoglobulin G Fc fragments aids immunoglobulins A, G, M, D, and E in the diagnosis of plasma cell anti- immunological test system is a device body-forming abnormalities, e.g., that consists of the reagents used to gamma heavy chain disease. measure by immunochemical tech- (b) Classification. Class I (general con- niques the immunoglobulins A, G, M, trols). The device is exempt from the D, an E (serum antibodies) in serum. premarket notification procedures in Measurement of these subpart E of part 807 of this chapter immunoglobulins aids in the diagnosis subject to the limitations in § 866.9. of abnormal protein metabolism and [47 FR 50823, Nov. 9, 1982, as amended at 61 the body’s lack of ability to resist in- FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, fectious agents. 2001] (b) Classification. Class II (perform- ance standards). § 866.5540 Immunoglobulin G (Fd frag- ment specific) immunological test § 866.5520 Immunoglobulin G (Fab system. fragment specific) immunological (a) Identification. An immunoglobulin test system. G (Fd fragment specific) immunolog- (a) Identification. An immunoglobulin ical test system is a device that con- G (Fab fragment specific) immunolog- sists of the reagents used to measure ical test system is a device that con- by immunochemical techniques the sists of the reagents used to measure amino terminal (antigen-binding) end by immunochemical techniques the (Fd fragment) of the heavy chain (a

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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 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 59 [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, FR 2312, Jan. 14, 2000] 2001] § 866.5570 immunological § 866.5550 Immunoglobulin (light test system. chain specific) immunological test system. (a) Identification. A lactoferrin immunological test system is a device (a) Identification. An immunoglobulin that consists of the reagents used to (light chain specific) immunological measure by immunochemical tech- test system is a device that consists of niques the lactoferrin (an iron-binding the reagents used to measure by protein with the ability to inhibit the immunochemical techniques both growth of bacteria) in serum, breast kappa and lambda types of light chain milk, other body fluids, and tissues. portions of immunoglobulin molecules Measurement of lactoferrin may aid in in serum, other body fluids, and tis- the diagnosis of an inherited deficiency sues. In some disease states, an excess of this protein. of light chains are produced by the (b) Classification. Class I (general con- antibody-forming cells. These free trols). The device is exempt from the light chains, unassociated with gamma premarket notification procedures in globulin molecules, can be found in a subpart E of part 807 of this chapter patient’s body fluids and tissues. Meas- subject to § 866.9. urement of the various amounts of the different types of light chains aids in [47 FR 50823, Nov. 9, 1982, as amended at 65 the diagnosis of multiple myeloma FR 2312, Jan. 14, 2000] (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of § 866.5580 Alpha-1-lipoprotein immun- lymphoid tissue), Waldenstrom’s ological test system. macroglobulinemia (increased produc- (a) Identification. An alpha-1- tion of large immunoglobulins), and lipoprotein immunological test system connective tissue diseases such as is a device that consists of the reagents rheumatoid arthritis or systemic lupus used to measure by immunochemical erythematosus. techniques the alpha-1-lipoprotein (b) Classification. Class II (perform- (high-density lipoprotein) in serum and ance standards). plasma. Measurement of alpha-1- lipoprotein may aid in the diagnosis of § 866.5560 Lactic dehydrogenase Tangier disease (a hereditary disorder immunological test system. of fat metabolism). (a) Identification. A lactic dehydro- (b) Classification. Class II (perform- genase immunological test system is a ance standards). device that consists of the reagents used to measure by immunochemical § 866.5590 Lipoprotein X immunolog- techniques the activity of the lactic ical test system. dehydrogenase enzyme in serum. In- (a) Identification. A lipoprotein X creased levels of lactic dehydrogenase immunological test system is a device are found in a variety of conditions, in- that consists of the reagents used to cluding megaloblastic anemia (de- measure by immunochemical tech- crease in the number of mature red niques lipoprotein X (a high-density blood cells), myocardial infarction lipoprotein) in serum and other body (heart disease), and some forms of leu- fluids. Measurement of lipoprotein X

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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 subpart E of part 807 of this chapter other body fluids. Measurements of subject to § 866.9. these antibodies aid in the diagnosis of [47 FR 50823, Nov. 9, 1982, as amended at 65 infectious mononucleosis. FR 2313, Jan. 14, 2000] (b) Classification. Class II (perform- ance standards). § 866.5600 Low-density lipoprotein immunological test system. [47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982] (a) Identification. A low-density lipoprotein immunological test system § 866.5660 Multiple autoantibodies is a device that consists of the reagents immunological test system. used to measure by immunochemical (a) Identification. A multiple techniques the low-density lipoprotein autoantibodies immunological test sys- in serum and other body fluids. Meas- tem is a device that consists of the re- urement of low-density lipoprotein in agents used to measure by serum may aid in the diagnosis of dis- immunochemical techniques the orders of lipid (fat) metabolism and autoantibodies (antibodies produced help to identify young persons at risk against the body’s own tissues) in from cardiovascular diseases. serum and other body fluids. Measure- (b) Classification. Class II (perform- ment of multiple autoantibodies aids ance standards). in the diagnosis of autoimmune dis- § 866.5620 Alpha-2- orders (disease produced when the immunological test system. body’s own tissues are injured by autoantibodies). (a) Identification. An alpha-2- (b) Classification. Class II (perform- macroglobulin immunological test sys- ance standards). tem is a device that consists of the re- agents used to measure by § 866.5680 Myoglobin immunological immunochemical techniques the alpha- test system. 2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2- (a) Identification. A myoglobin macroglobulin may aid in the diagnosis immunological test system is a device of blood-clotting or clot lysis disorders. that consists of the reagents used to (b) Classification. Class II (perform- measure by immunochemical tech- ance standards). niques the myoglobin (an oxygen stor- age protein found in muscle) in serum § 866.5630 Beta-2- and other body fluids. Measurement of immunological test system. myoglobin aids in the rapid diagnosis (a) Identification. A beta-2-microglob- of heart or renal disease. ulin immunological test system is a de- (b) Classification. Class II (perform- vice that consists of the reagents used ance standards). to measure by immunochemical tech- niques beta-2-microglobulin (a protein § 866.5700 Whole human plasma or molecule) in serum, urine, and other serum immunological test system. body fluids. Measurement of beta-2- (a) Identification. A whole human microglobulin aids in the diagnosis of plasma or serum immunological test active rheumatoid arthritis and kidney system is a device that consists of re- disease. agents used to measure by (b) Classification. Class II (perform- immunochemical techniques the pro- ance standards). teins in plasma or serum. Measure- ments of proteins in plasma or serum § 866.5640 Infectious mononucleosis aid in the diagnosis of any disease con- immunological test system. cerned with abnormal levels of plasma (a) Identification. An infectious mono- or serum proteins, e.g., agammaglobu- nucleosis immunological test system is linemia, allergies, multiple myeloma,

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rheumatoid vasculitis, or hereditary § 866.5750 Radioallergosorbent (RAST) angioneurotic edema. immunological test system. (b) Classification. Class I (general con- (a) Identification. A trols). The device is exempt from the radioallergosorbent immunological premarket notification procedures in test system is a device that consists of subpart E of part 807 of this chapter the reagents used to measure by subject to the limitations in § 866.9. immunochemical techniques the aller- gen antibodies (antibodies which cause [47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, an allergic reaction) specific for a 2001] given allergen. Measurement of specific allergen antibodies may aid in the di- § 866.5715 Plasminogen immunological agnosis of asthma, allergies, and other test system. pulmonary disorders. (a) Identification. A plasminogen (b) Classification. Class II (perform- ance standards). immunological test system is a device that consists of the reagents used to § 866.5765 Retinol-binding protein measure by immunochemical tech- immunological test system. niques the plasminogen (an inactive (a) Identification. A retinol-binding substance from which , a blood- protein immunological test system is a clotting factor, is formed) in serum, device that consists of the reagents other body fluids, and tissues. Measure- used to measure by immunochemical ment of plasminogen levels may aid in techniques the retinol-binding protein the diagnosis of fibrinolytic (blood- that binds and transports vitamin A in clotting) disorders. serum and urine. Measurement of this (b) Classification. Class I (general con- protein may aid in the diagnosis of kid- trols). The device is exempt from the ney disease and in monitoring patients premarket notification procedures in with kidney transplants. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to § 866.9. trols). The device is exempt from the [47 FR 50823, Nov. 9, 1982, as amended at 65 premarket notification procedures in FR 2313, Jan. 14, 2000] subpart E of part 807 of this chapter subject to § 866.9. § 866.5735 Prothrombin immunological [47 FR 50823, Nov. 9, 1982, as amended at 65 test system. FR 2313, Jan. 14, 2000] (a) Identification. A prothrombin immunological test system is a device § 866.5775 Rheumatoid factor immuno- that consists of the reagents used to logical test system. measure by immunochemical tech- (a) Identification. A rheumatoid factor niques the prothrombin (clotting factor immunological test system is a device II) in serum. Measurements of the that consists of the reagents used to amount of antigenically competent measure by immunochemical tech- (ability to react with protein anti- niques the rheumatoid factor (anti- bodies) prothrombin aid in the diag- bodies to immunoglobulins) in serum, nosis of blood-clotting disorders. other body fluids, and tissues. Measure- (b) Classification. Class I (general con- ment of rheumatoid factor may aid in trols). The device is exempt from the the diagnosis of rheumatoid arthritis. premarket notification procedures in (b) Classification. Class II (perform- subpart E of part 807 of this chapter ance standards). subject to § 866.9. This exemption does § 866.5785 Anti-Saccharomyces not apply to multipurpose systems for cerevisiae (S. cerevisiae) antibody in vitro coagulation studies classified (ASCA) test systems. under § 864.5425 of this chapter or pro- (a) Identification. The Anti-Saccharo- thrombin time tests classified under myces cerevisiae (S. cerevisiae) antibody § 864.7750 of this chapter. (ASCA) test system is an in vitro diag- [47 FR 50823, Nov. 9, 1982, as amended at 65 nostic device that consists of the re- FR 2313, Jan. 14, 2000] agents used to measure, by

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immunochemical techniques, anti- that consists of the reagents used to bodies to S. cerevisiae (baker’s or brew- measure by immunochemical tech- er’s yeast) in human serum or plasma. niques the total protein in cerebro- Detection of S. cerevisiae antibodies spinal fluid. Measurement of spinal may aid in the diagnosis of Crohn’s dis- fluid proteins may aid in the diagnosis ease. of multiple sclerosis and other diseases (b) Classification. Class II (special of the nervous system. controls). The special control is FDA’s (b) Classification. Class I (general con- ‘‘Guidance for Industry and FDA Re- trols). The device is exempt from the viewers: Class II Special Control Guid- premarket notification procedures in ance Document for Anti-Saccharomyces subpart E of part 807 of this chapter cerevisiae (S. cerevisiae) Antibody subject to the limitations in § 866.9. (ASCA) Premarket Notifications.’’ [47 FR 50823, Nov. 9, 1982, as amended at 61 [65 FR 70307, Nov. 22, 2000] FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] § 866.5800 Seminal fluid (sperm) immunological test system. § 866.5870 Thyroid autoantibody (a) Identification. A seminal fluid immunological test system. (sperm) immunological test system is a (a) Identification. A thyroid device that consists of the reagents autoantibody immunological test sys- used for legal purposes to identify and tem is a device that consists of the re- differentiate animal and human semen. agents used to measure by The test results may be used as court immunochemical techniques the thy- evidence in alleged instances of rape roid autoantibodies (antibodies pro- and other sex-related crimes. duced against the body’s own tissues). (b) Classification. Class I (general con- Measurement of thyroid autoantibodies trols). The device is exempt from the may aid in the diagnosis of certain thy- premarket notification procedures in roid disorders, such as Hashimoto’s dis- subpart E of part 807 of this chapter ease (chronic lymphocytic thyroiditis), subject to the limitations in § 866.9. nontoxic goiter (enlargement of thy- [54 FR 25047, June 12, 1989, as amended at 66 roid gland), Grave’s disease (enlarge- FR 38793, July 25, 2001] ment of the thyroid gland with protru- sion of the eyeballs), and cancer of the § 866.5820 Systemic lupus thyroid. erythematosus immunological test (b) Classification. Class II (perform- system. ance standards). (a) Identification. A systemic lupus erythematosus (SLE) immunological § 866.5880 Transferrin immunological test system is a device that consists of test system. the reagents used to measure by (a) Identification. A transferrin immunochemical techniques the immunological test system is a device autoimmune antibodies in serum and that consists of the reagents used to other body fluids that react with cel- measure by immunochemical tech- lular nuclear double-stranded niques the transferrin (an iron-binding deoxyribonucleic acid (DNA) or other and transporting serum protein) in nuclear constituents that are specifi- serum, plasma, and other body fluids. cally diagnostic of SLE. Measurement Measurement of transferrin levels aids of nuclear double-stranded DNA anti- in the diagnosis of malnutrition, acute bodies aids in the diagnosis of SLE (a inflammation, infection, and red blood multisystem autoimmune disease in cell disorders, such as iron deficiency which tissues are attacked by the per- anemia. son’s own antibodies). (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). § 866.5890 Inter-alpha trypsin inhibitor § 866.5860 Total spinal fluid immuno- immunological test system. logical test system. (a) Identification. An inter-alpha (a) Identification. A total spinal fluid trypsin inhibitor immunological test immunological test system is a device system is a device that consists of the

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reagents used to measure by Subpart B—Diagnostic Devices immunochemical techniques the inter- alpha trypsin inhibitor (a protein) in 868.1030 Manual algesimeter. 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. may aid in the diagnosis of acute bac- 868.1120 Indwelling blood oxyhemoglobin terial infection and inflammation. concentration analyzer. (b) Classification. Class I (general con- 868.1150 Indwelling blood carbon dioxide trols). The device is exempt from the partial pressure (PCO2) analyzer. premarket notification procedures in 868.1170 Indwelling blood hydrogen ion con- centration (pH) analyzer. subpart E of part 807 of this chapter 868.1200 Indwelling blood oxygen partial subject to § 866.9. pressure (PO2) analyzer. 868.1400 Carbon dioxide gas analyzer. [47 FR 50823, Nov. 9, 1982, as amended at 53 868.1430 Carbon monoxide gas analyzer. FR 11253, Apr. 6, 1988; 65 FR 2313, Jan. 14, 868.1500 Enflurane gas analyzer. 2000] 868.1575 Gas collection vessel. 868.1620 Halothane gas analyzer. Subpart G—Tumor Associated 868.1640 Helium gas analyzer. Antigen immunological Test 868.1670 Neon gas analyzer. 868.1690 Nitrogen gas analyzer. Systems 868.1700 Nitrous oxide gas analyzer. 868.1720 Oxygen gas analyzer. § 866.6010 Tumor-associated antigen 868.1730 Oxygen uptake computer. immunological test system. 868.1750 Pressure plethysmograph. (a) Identification. A tumor-associated 868.1760 Volume plethysmograph. antigen immunological test system is a 868.1780 Inspiratory airway pressure meter. 868.1800 Rhinoanemometer. device that consists of reagents used to 868.1840 Diagnostic spirometer. qualitatively or quantitatively meas- 868.1850 Monitoring spirometer. ure, by immunochemical techniques, 868.1860 Peak-flow meter for spirometry. tumor-associated antigens in serum, 868.1870 Gas volume calibrator. plasma, urine, or other body fluids. 868.1880 Pulmonary-function data calcu- This device is intended as an aid in lator. monitoring patients for disease 868.1890 Predictive pulmonary-function progress or response to therapy or for value calculator. 868.1900 Diagnostic pulmonary-function in- the detection of recurrent or residual terpretation calculator. disease. 868.1910 Esophageal stethoscope. (b) Classification. Class II (special 868.1920 Esophageal stethoscope with elec- controls). Tumor markers must comply trical conductors. with the following special controls: (1) 868.1930 Stethoscope head. A guidance document entitled ‘‘Guid- 868.1965 Switching valve (ploss). ance Document for the Submission of 868.1975 Water vapor analyzer. Tumor Associated Antigen Premarket Subpart C—Monitoring Devices Notifications (510(k)s) to FDA,’’ and (2) voluntary assay performance standards 868.2025 Ultrasonic air embolism monitor. issued by the National Committee on 868.2300 Bourdon gauge flowmeter. Clinical Laboratory Standards. 868.2320 Uncompensated thorpe tube flow- meter. [62 FR 66005, Dec. 17, 1997] 868.2340 Compensated thorpe tube flow- meter. 868.2350 Gas calibration flowmeter. PART 868—ANESTHESIOLOGY 868.2375 Breathing frequency monitor. DEVICES 868.2380 Nitric oxide analyzer. 868.2385 Nitrogen dioxide analyzer. Subpart A—General Provisions 868.2450 Lung water monitor. 868.2480 Cutaneous carbon dioxide (PcCO2) Sec. monitor. 868.1 Scope. 868.2500 Cutaneous oxygen monitor. 868.3 Effective dates of requirement for pre- 868.2550 Pneumotachometer. market approval. 868.2600 Airway pressure monitor. 868.9 Limitations of exemptions from sec- 868.2610 Gas pressure gauge. tion 510(k) of the Federal Food, Drug, 868.2620 Gas pressure calibrator. and Cosmetic Act (the act). 868.2700 Pressure regulator.

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