Food and Drug Administration, HHS § 866.5320

§ 866.5240 Complement components (b) Classification. Class II (perform- immunological test system. ance standards). (a) Identification. A complement com- § 866.5270 C-reactive protein immuno- ponents immunological test system is logical test system. a device that consists of the reagents used to measure by immunochemical (a) Identification. A C-reactive protein techniques complement components immunological test system is a device C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and that consists of the reagents used to C9, in serum, other body fluids, and tis- measure by immunochemical tech- sues. Complement is a group of serum niques the C-reactive protein in serum proteins which destroy infectious and other body fluids. Measurement of agents. Measurements of these proteins C-reactive protein aids in evaluation of aids in the diagnosis of immunologic the amount of injury to body tissues. disorders, especially those associated (b) Classification. Class II (perform- with deficiencies of complement com- ance standards). ponents. (b) Classification. Class II (perform- § 866.5320 Properdin factor B immuno- ance standards). logical test system. [47 FR 50823, Nov. 9, 1982, as amended at 53 (a) Identification. A properdin factor FR 11253, Apr. 6, 1988] B immunological test system is a device that consists of the reagents used § 866.5250 Complement C 2 inhibitor to measure by immunochemical tech- (inactivator) immunological test niques properdin factor B in serum and system. other body fluids. The deposition of (a) Identification. A complement C1 properdin factor B in body tissues or a inhibitor (inactivator) immunological corresponding depression in the test system is a device that consists of amount of properdin factor B in serum the reagents used to measure by and other body fluids is evidence of the immunochemical techniques the com- involvement of the alternative to the plement C1 inhibitor (a plasma protein) classical pathway of activation of com- in serum. Complement C1 inhibitor oc- plement (a group of plasma proteins curs normally in plasma and blocks the which cause the destruction of cells action of the C1 component of com- which are foreign to the body). Meas- plement (a group of serum proteins urement of properdin factor B aids in which destroy infectious agents). Meas- the diagnosis of several kidney dis- urement of complement C1 inhibitor eases, e.g., chronic glomerulonephritis aids in the diagnosis of hereditary (inflammation of the glomeruli of the angioneurotic edema (increased blood kidney), lupus nephritis (kidney dis- vessel permeability causing swelling of ease associated with a multisystem tissues) and a rare form of angioedema autoimmune disease, systemic lupus associated with lymphoma (lymph node erythematosus), as well as several skin cancer). diseases, e.g., dermititis herpetiformis (b) Classification. Class II (perform- (presence of vesicles on the skin that ance standards). burn and itch), and pemphigus vulgaris (large vesicles on the skin). Other dis- § 866.5260 Complement C3b inactivator immunological test system. eases in which the alternate pathway of complement activation has been im- (a) Identification. A complement C3b plicated include rheumatoid arthritis, inactivator immunological test system sickle cell anemia, and gram-negative is a device that consists of the reagents bacteremia. used to measure by immunochemical (b) Classification. Class II (special techniques the complement C 3b controls). The device is exempt from inactivator (a plasma protein) in the premarket notification procedures serum. Complement is a group of serum in subpart E of part 807 of this chapter proteins that destroy infectious agents. subject to § 866.9. Measurement of complement C3b inactivator aids in the diagnosis of in- [47 FR 50823, Nov. 9, 1982, as amended at 63 herited antibody dysfunction. FR 59227, Nov. 3, 1998]

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