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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Recognition 01/27/2015 
FR Recognition Number 7-250
Standard
CLSI M40-A2
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 and
Section 11.2: Recovery.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§866.2900 Device, Parasite Concentration Class 1 LKS
§866.2900 Device, Specimen Collection Class 1 LIO
§866.2900 System, Transport, Aerobic Class 1 JTW
§866.2900 Transport Systems, Anaerobic Class 1 JTX
§866.2390 Culture Media, Anaerobic Transport Class 1 JSL
§866.2390 Culture Media, Non-Propagating Transport Class 1 JSM
§866.2360 Culture Media, Selective Broth Class 1 JSD
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Michael Waters
  FDA/OMPT/CDRH/OIR/DMD/BAC1/
  301-796-4653
  michael.waters@fda.hhs.gov
 Kimberly Sconce
  FDA/OMPT/CDRH/OIR/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
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