[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR660.34]

[Page 114-115]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--Table of Contents
 
                   Subpart D--Reagent Red Blood Cells
 
Sec. 660.34  Processing.

    (a) Processing method. The processing method shall be one that has 
been shown to yield consistently a product that is capable of detecting, 
throughout the dating period, alloantibodies corresponding to all 
required blood group antigens specified in the labeling as present.
    (b) Products prepared from pooled red blood cells. If the product is 
recommended for the detection of unexpected antibodies, the pool shall 
be prepared by combining equal amounts of cells from no more than two 
donors. Umbilical cord cells are exempt from this requirement. Pooled 
cells shall not be recommended for pretransfusion tests, done in lieu of 
a major crossmatch, to detect unexpected antibodies in patients' 
samples.
    (c) Absence of antibodies. Each lot of final product shall be free 
of demonstrable antibodies, including anti-A and anti-B, unless the 
package insert and container lable include instructions to wash the 
cells before use. The final product shall also be direct

[[Page 115]]

antiglobulin test negative when tested with polyspecific anti-human 
globulin.
    (d) Final container. The final containers used for each lot of 
product shall be clean and shall permit observation of the contents for 
hemolysis or a change in color. The final container label, container 
cap, and dropper bulb of a Reagent Red Blood Cell product may be color-
coded with a visual match to a specific color approved by the Director, 
Center for Biologics Evaluation and Research.
    (e) Date of manufacture. The date of manufacture of the product 
shall be the date that the blood is withdrawn from the donor or obtained 
from umbilical cords. The period during which the reagent red blood cell 
source material is kept by the manufacturer in storage in a frozen state 
at -65  deg.C or colder is excluded from the dating period. If the 
product consists of red blood cells from two or more donors, the date of 
manufacture of the final product shall be the date of withdrawal of 
blood from the donor of the oldest constituent blood. When a product 
consists of more than one container, e.g., cell panel, the date of 
manufacture of each container of the product shall be the earliest date 
that blood was withdrawn from a donor for any container of the product.
    (f) Retention samples. Retention samples shall be maintained as 
required by Sec. 600.13 of this chapter, except that samples must be 
retained only throughout the dating period of the product.

(Approved by the Office of Management and Budget under control number 
0910-0073)

[52 FR 37450, Oct. 7, 1987, as amended at 55 FR 11013, Mar. 26, 1990]