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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 055 Date of Entry 12/21/2020 
FR Recognition Number 7-300
Standard
CLSI  MM13 2nd Edition
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
Scope/Abstract
This guideline describes general technical principles for ensuring optimal specimen collection, transport, storage, and nucleic acid isolation for molecular diagnostic test methods. It is intended for all health care professionals responsible for obtaining and transporting specimens from patients or preparing samples for molecular tests.

It is also intended for manufacturers of specimen collection devices and sample preparation reagents, kits, and instrumentation. This guideline also describes specimen collection and transport devices, sample preparation methods and optimal storage conditions, and special precautions for molecular methods. Although this guideline is intended for diagnostic testing, the principles described here may apply to other areas.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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
 David Goodwin
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1/
  301-796-6932
  David.Goodwin@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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