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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 021 Date of Entry 03/18/2009 
FR Recognition Number 7-190
CLSI  M50-A (Replaces M50-P)
Quality Control for Commercial Microbial Identification Systems; Approved Guideline
This standard includes a process for streamlined quality control (QC) of commercial microbial identification systems (MISs) that utilize multiple substrates and/or reagents to identify aerobic or anaerobic bacteria, yeasts, moulds, or yeastlike algae from culture. It specifies responsibilities of the manufacturer, distributor, and user. M50-A includes guidelines that may be followed when using an MIS of proven reliability to take a modified QC approach, rather than meeting requirements included in the Clinical Laboratory Improvement Amendments of 1988 regulations. The streamlined QC approach was developed following an evaluation of data provided by the American Society for Microbiology for a survey conducted to determine the QC failure rates of commercial MISs. The data showed a failure rate of less than 0.1% for all commercial MISs surveyed. This document is based on United States (US) regulations and will also serve as a useful resource for a wider audience. It is anticipated that M50-A will be used extensively in the United States and internationally to reduce resources spent on excessive QC testing.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.2660 Gram Positive Identification Panel Class 1 LQL
§866.2660 Instrument For Auto Reader Of Overnight Microorganism Identification System Class 1 LRH
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
 Ribhi Shawar
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.