[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: 21CFR866.1645]

[Page 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. 866.1645  Fully automated short-term incubation cycle antimicrobial susceptibility system.

    Effective Date Note: At 68 FR 5827, Feb. 5, 2003, Sec. 866.1645 was 
added, effective May 6, 2003. For the convenience of the user, the added 
text is set forth below.
    (a) Identification. A fully automated short-term incubation cycle 
antimicrobial susceptibility system is a device that incorporates 
concentrations of antimicrobial agents into a system for the purpose of 
determining in vitro susceptibility of bacterial pathogens isolated from 
clinical specimens. Test results obtained from short-term (less than 16 
hours) incubation are used to determine the antimicrobial agent of 
choice to treat bacterial diseases.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Antimicrobial Susceptibility Test (AST) 
Systems; Guidance for Industry and FDA.''