TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES

subpart d - SEROLOGICAL REAGENTS

866.3510 - Rubella virus serological reagents.

  (a) Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

  (b) Classification. Class II. The special controls for this device are: (1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997, (ii) 1/LA18 Specifications for Immunological Testing for Infectious Diseases, December 1994, (iii) D13 Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993, (iv) EP5 Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999, and (v) EP10 Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998, (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.

[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987; 65 FR 17144, Mar. 31, 2000]