Food and Drug Administration, HHS § 866.5320

Food and Drug Administration, HHS § 866.5320

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 de- vice 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] 315 VerDate Mar<15>2010 18:43 May 19, 2014 Jkt 232077 PO 00000 Frm 00325 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150.

View Full Text

Details

  • File Type
    pdf
  • Upload Time
    -
  • Content Languages
    English
  • Upload User
    Anonymous/Not logged-in
  • File Pages
    1 Page
  • File Size
    -

Download

Channel Download Status
Express Download Enable

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

  • Not to be reproduced or distributed without explicit permission.
  • Not used for commercial purposes outside of approved use cases.
  • Not used to infringe on the rights of the original creators.
  • If you believe any content infringes your copyright, please contact us immediately.

Support

For help with questions, suggestions, or problems, please contact us