[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.1620]

[Page 235]
 
                        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 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).