[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: 21CFR660.25]

[Page 111-112]
 
                        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 C--Blood Grouping Reagent
 
Sec. 660.25  Potency tests without reference preparations.

    Products for which Reference Blood Grouping Reagents are not 
available shall be tested for potency by a method approved by the 
Director, Center for Biologics Evaluation and Research (HFN-830), Food 
and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892.
    (a) Potency requirements. Blood Grouping Reagents recommended for 
the test tube methods, including the indirect antiglobulin tests, shall 
have the following potency titer values, unless other values are 
approved by the Director, Center for Biologics Evaluation and Research 
(HFN-830), Food and Drug Administration, 8800 Rockville Pike, Bethesda, 
MD 20892.
    (1) For Anti-K, Anti-k, Anti-Jk a, Anti-Fy a, 
Anti-C w, at least 1+ reaction with a 1:8 dilution of the 
reagent.
    (2) For Anti-S, Anti-s, Anti-P1, Anti-M, Anti-I, Anti-e 
(saline), Anti-c (saline), and Anti-A1, at least 1+ reaction 
with a 1:4 dilution of the reagent.
    (3) For Anti-U, Anti-Kpa, Anti-Kpb, Anti-
Jsa, Anti-Jsb, Anti-Fyb, Anti-N, Anti-
Lea, Anti-Leb, Anti-Lua, Anti-
Lub, Anti-Dia, Anti-Mg, Anti-
Jkb, Anti-Cob,

[[Page 112]]

Anti-Wra, and Anti-Xga, at least 2+ reaction with 
undiluted reagent.
    (b) Products recommended for slide tests or microplate techniques. 
Blood Grouping Reagent recommended for slide test methods or microplate 
techniques shall produce clearly positive macroscopic results when both 
undiluted reagent and reagent diluted with an equal volume of diluent 
are tested by all methods recommended in the manufacturer's package 
insert using red blood cells showing heterozygous or diminished 
expression of the corresponding antigen. The dilution shall be made with 
an equal volume of compatible serum or approved diluent.
    (c) Products recomended for use in an automated system. The 
manufacturer of Blood Grouping Reagent that is recommended for use in an 
automated system shall demonstrate that its product when used both 
undiluted and diluted with an equal volume of diluent satisfactorily 
performs when tested with cells representing heterozygous or diminished 
expression of the corresponding antigen.

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0209)