Methods for Antimicrobial Dilution and Disk Susceptibility Testing of
7-218 InVitro Infrequently Isolated or Fastidious
Bacteria; Approved Guideline -
Second Edition
M45-A2 08/05/2013 CLSI
Recognition List Number: 031 Publication Date: 08/05/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-218: CLSI M45-A2, Methods for Antimicrobial Dilution and
Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved
Guideline - Second Edition. (InVitro Diagnostics)
Date of Standard: 2006.
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:
Antimicrobial Susceptibility minimum inhibitory concentration (MIC) and disk diffusion devices.
Processes Affected:
510(k), Pre-submission
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
§866.1620
21
Discs, Elution
§866.1620
23
Susceptibility Test Discs, Antimicrobial
Regulation
Number
Device Name
§866.1640
25
Manual Antimicrobial Susceptibility Test Systems
§866.1640
27
Panels, Test, Susceptibility, Antimicrobial
§866.1640
29
Solution, Antimicrobial
§866.1640
31
Susceptibility Test Cards, Antimicrobial
§866.1640
33
Susceptibility Test Powders, Antimicrobial
§866.1640
35
Susceptibility Test Powders, Antimycobacterial
Regulation
Number
Device Name
Device Product
Class Code
Class 2
Class 2
Class 2
LTX
Class 2 JTN
JWY
Class 2 LTT
Class 2 LOP
LTW
Class 2 JTT
Class 2 MJA
22
24
26
28
30
32
34
36
Device Product
Class Code
Device Product
Class Code
Class 2 LON 38 §866.1645
37
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Regulation
Number
Device Name
Device Product
Class Code
§866.1700
§866.1700
39
41
Culture Media, Antifungal, Susceptibility Test
Culture Media, Antimicrobial Susceptibility Test
Class 2 MJE 40
Class 2 LKA 42
§866.1700
43
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Class 2 JSO 44

§866.1700
45
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Class 2 JTZ 46
§866.1700
47
Culture Media, Antimycobacteria, Susceptibility Test Class 2 MJD 48
Relevant Guidance:
There is no relevant guidance developed at this time.

Code of Federal Regulations]
[Title 21, Volume 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
8
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]
[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
8
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]
[Revised as of April 1, 2013]
[CITE: 21CFR866.1645]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
8
PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart B--Diagnostic Devices
Sec. 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(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."
[68 FR 5827, Feb. 5, 2003]

[Code of Federal Regulations]
[Title 21, Volume 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
8
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).