[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR660.33]

[Page 125]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 660_ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--
 
                    Subpart D_Reagent Red Blood Cells
 
Sec. 660.33  Testing of source material.

    Except as provided in this section, a sample of each blood 
incorporated into the Reagent Red Blood Cell product shall be 
individually tested, with no fewer than two donor sources of each 
antibody specificity employed, to confirm the identification of all 
blood group antigens specified in the labeling as present or absent. The 
manufacturer shall perform at least one of the required tests for each 
factor. The Reagent Red Blood Cell product may be tested with a single 
donor source of antibody specificity if only one source of antibody is 
available, and the Director, Center for Biologics Evaluation and 
Research, has approved the use of a single donor source of antiserum. 
Each of these tests shall be conducted and interpreted independently, 
and any discrepancy between the results of these two tests shall be 
resolved by testing with at least one additional antiserum before 
concluding that the antigen is present or absent. Where fewer than three 
donor sources of an antibody specificity are available, test 
discrepancies shall be resolved in accordance with the manufacturer's 
biologics license application. Group O Reagent Red Blood Cells used in 
the detection or identification of unexpected antibodies shall include 
at least the following common antigens in each lot of the product: D, C, 
E, c, e, K, k, Fya, Fyb, Jka, 
Jkb, Lea, Leb, P1, M, N, S, 
and s.

[52 FR 37450, Oct. 7, 1987, as amended at 55 FR 11013, Mar. 26, 1990; 64 
FR 56454, Oct. 20, 1999]