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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 7-250
Standard
CLSI  M40-A2 (Reaffirmed: September 2019)
Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
Scope/Abstract
This document provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 8.9 Direct Colony Suspension Inoculum Preparation Method
Table 2: Aerobic and Anaerobic Facultative Bacteria
Table 3: Anaerobic Bacteria
Table 4: Fastidious Bacteria
Section 8.11.5: Recovery
Table 5: Aerobic and Anaerobic Facultative Bacteria
Table 6: Anaerobic Bacteria
Table 7: Fastidious Bacteria
Section 8.11.1 Inoculum Density
Section 8.12.5: Recovery
Section 9.2.1: Quality Control Organisms for Urine Transport Devices
Table 8: Microorganisms for Use in Performing QC Testing for Urine Transport Devices
Section 9.3.1: Quality Control Organisms for Fecal Transport Devices
Table 9: Organisms for Use in Performing QC Testing for Fecal Transport Devices
Section 9.3 Fecal Culture Containers With Preservative
9.3.2: Inoculum Preparation
Section 9.3.4 Recovery
Section 11.2: Viral Recovery
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.2360 Culture Media, Selective Broth Class 1 JSD
§866.2390 Culture Media, Anaerobic Transport Class 1 JSL
§866.2390 Culture Media, Non-Propagating Transport Class 1 JSM
§866.2900 System, Transport, Aerobic Class 1 JTW
§866.2900 Transport Systems, Anaerobic Class 1 JTX
§866.2900 Device, Specimen Collection Class 1 LIO
§866.2900 Device, Parasite Concentration Class 1 LKS
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Kimberly Sconce
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC2/
  301-796-6679
  kimberly.sconce@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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