[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.1620]

[Page 244-245]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 866.1620  Antimicrobial susceptibility test disc.


    (a) Identification. An antimicrobial susceptibility test disc is a 
device that consists of antimicrobic-impregnated paper discs used to 
measure by a disc-agar diffusion technique or a disc-broth elution 
technique the in vitro susceptibility of most clinically important 
bacterial pathogens to antimicrobial agents. In the disc-agar diffusion 
technique, bacterial susceptibility is

[[Page 245]]

ascertained by directly measuring the magnitude of a zone of bacterial 
inhibition around the disc on an agar surface. The disc-broth elution 
technique is associated with an automated rapid susceptibility test 
system and employs a fluid medium in which susceptibility is ascertained 
by photometrically measuring changes in bacterial growth resulting when 
antimicrobial material is eluted from the disc into the fluid medium. 
Test results are used to determine the antimicrobial agent of choice in 
the treatment of bacterial diseases.
    (b) Classification. Class II (performance standards).