• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 7-295
Standard
CLSI M52, 1st ed. August 2015 (Reaffirmed: January 2020)
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
Scope/Abstract
This guideline provides recommendations for clinical laboratory professionals for verification of commercial microbial identification systems (MIS) and US Food and Drug Administration (FDA)-cleared antimicrobial susceptibility testing systems (ASTS) to fulfill regulatory or QA requirements for use in diagnostic testing. Recommendations for postverification QA are also included. This guideline focuses on instrument-based systems commonly used in clinical laboratories, but the recommendations may also be applicable to manual methods for microbial identification (ID) and antimicrobial susceptibility testing (AST), including disk diffusion and gradient diffusion strips.

This guideline is not intended to provide guidance to manufacturers of in vitro diagnostic devices. A manufacturer must perform many studies during the research and development phases and the manufacturing validation phase that are unique to the design of the test system and the manufacturing processes. These studies go beyond the scope of this document. See Appendix A for a description of the FDA requirements for MIS and ASTS clearance.
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
§866.1640 Susceptibility Test Powders, Antimicrobial Class 2 JTT
§866.1640 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§866.1640 Reagent/Device, Inoculum Calibration Class 2 LIE
§866.1640 Solution, Antimicrobial Class 2 LOP
§866.1640 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class 2 LRG
§866.1640 Panels, Test, Susceptibility, Antimicrobial Class 2 LTT
§866.1640 Susceptibility Test Cards, Antimicrobial Class 2 LTW
§866.1640 Susceptibility Test Powders, Antimycobacterial Class 2 MJA
§866.1640 System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies Class 2 MYI
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1640 System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species Class 2 NIJ
§866.1640 System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Class 2 NQX
§866.1640 System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony Class 2 PMY
§866.1640 System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen Class 2 POC
§866.1640 Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates Class 2 PTJ
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
§866.1650 Positive Blood Culture Identification And Ast Kit Class 2 PRH
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued August 28, 2009.
FDA Technical Contact
 Natasha Griffin
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1
  301-796-0522
  Natasha.Griffin@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.
-
-