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 antibodies. As the reagents Systems come in contact with each other, they combine to form a precipitate that is § 866.5040 Albumin 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 259 VerDate Apr<18>2002 06:36 Apr 28, 2002 Jkt 197069 PO 00000 Frm 00259 Fmt 8010 Sfmt 8010 Y:\SGML\197069T.XXX pfrm12 PsN: 197069T § 866.5080 21 CFR Ch. I (4–1–02 Edition) 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 antibody (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). 260 VerDate Apr<18>2002 06:36 Apr 28, 2002 Jkt 197069 PO 00000 Frm 00260 Fmt 8010 Sfmt 8010 Y:\SGML\197069T.XXX pfrm12 PsN: 197069T Food and Drug Administration, HHS § 866.5210 § 866.5130 Alpha-1-antitrypsin immun- beta globulins (serum protein) in serum ological test system. and other body fluids. Beta-globulin (a) Identification. An alpha-1- proteins include beta-lipoprotein, antitrypsin immunological test system transferrin, 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.