Zone Diameter Interpretive
Standards, Corresponding Minimal
Inhibitory Concentration (MIC)
Interpretive Breakpoints, and
7-217 InVitro
M44-S3 08/05/2013 CLSI
Quality Control Limits for Antifungal
Disk Diffusion Susceptibility Testing
of Yeasts; Third Informational
Supplement
Recognition List Number: 031 Publication Date: 08/05/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-217: CLSI M44-S3, Zone Diameter Interpretive Standards,
Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and
Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts;
Third Informational Supplement. (InVitro Diagnostics)
Date of Standard: 2009.
Address of Standards Organization:
Clinical Laboratory Standards Institute (CLSI)
950 West Valley Road
Suite 2500
Wayne, PA 19087
CDRH Offices and Divisions Associated with Recognized Standards:
(1) OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF MICROBIOLOGY (DMD)
(2) OFFICE OF COMPLIANCE (OC)
Devices Affected:
Antifungal Susceptibility minimum inhibitory concentration (MIC) and disk diffusion
devices
Processes Affected:
510(k), Pre-suubmission
Type of Standard:
Horizontal, National
Extent of Recognition:
Complete standard, with the exception of the interpretive criteria and quality control
parameters when different from that in FDA approved drug labels. In the absence of
the interpretive criteria and quality control parameters in FDA approved drug labels,
consult the technical contacts.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name
Device Product
Class
Code
§866.162021 Discs, Elution
Class 2 LTX22
§866.162023 Susceptibility Test Discs, Antimicrobial
Class 2 JTN24
Regulation
Device Product
Number
Device Name
Class
Code
§866.164025 Susceptibility Test Plate, Antifungal
Class 2 NGZ26
Regulation
Device Product
Number
Device Name
Class
Code
§866.170027 Culture Media, Antifungal, Susceptibility Test Class 2 MJE28
Relevant Guidance:
There is no relevant guidance developed at this time.
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR866.1620]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES
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).
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR866.1640]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart B--Diagnostic Devices
Sec. 866.1640 Antimicrobial susceptibility test powder.
(a)Identification. An antimicrobial susceptibility test powder is a
device that consists of an antimicrobial drug powder packaged in vials
in specified amounts and intended for use in clinical laboratories for
determining in vitro susceptibility of bacterial pathogens to these
therapeutic agents. Test results are used to determine the antimicrobial
agent of choice in the treatment of bacterial diseases.
(b)Classification. Class II (performance standards).
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR866.1700]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart B--Diagnostic Devices
Sec. 866.1700 Culture medium for antimicrobial susceptibility tests.
(a)Identification. A culture medium for antimicrobial susceptibility
tests is a device intended for medical purposes that consists of any medium
capable of supporting the growth of many of the bacterial pathogens that
are subject to antimicrobial susceptibility tests. The medium should be
free of components known to be antagonistic to the common agents for which
susceptibility tests are performed in the treatment of disease.
(b)Classification. Class II (performance standards).