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

Recognized Consensus Standards: Medical Devices

  • 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 063 Date of Entry 12/23/2024 
FR Recognition Number 7-322
Standard
CLSI  M47 2nd Edition
Principles and Procedures for Blood Cultures
Scope/Abstract
This guideline is intended to provide recommendations to clinical microbiologists, other laboratorians (eg, pathologists, supervisors and/or managers, phlebotomists), and health care providers (HCPs) for recovering pathogens from the blood of patients with suspected bacteremia, mycobacteremia, or fungemia. It is also intended for administrators who develop institutional best practices. Specific recommendations for collecting, transporting, and processing blood culture specimens are also included.
This guideline discusses the clinical significance of blood cultures, critical factors in recovering pathogens from blood specimens, selection of medium formulations and other laboratory practices, and development of interpretive criteria. It also discusses existing blood culture technologies and the relative benefits of these technologies. Special topics, including pediatric blood cultures; catheter-related bloodstream infections (CRBSIs); infective endocarditis; diagnostic testing for patients who are receiving antimicrobial therapy; rare and fastidious pathogens; and rapid diagnostic techniques, including culture-independent methods, are also covered.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of CLSI M47-A (Replaces M47-P) [Rec# 7-189] will be superseded by recognition of CLSI M47 2nd Edition [Rec# 7-322]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-189] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 7-189] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
866.1650 Positive Blood Culture Identification And Ast Kit Class 2 PRH
866.1650 Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing Class 2 QZX
866.1650 Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples Class 2 SAN
§866.2300 Culture Media, Non-Selective And Non-Differential Class 1 JSG
§866.2560 Monitor, Microbial Growth Class 1 JTA
§866.2560 System, Blood Culturing Class 1 MDB
§866.3365 Gram-Positive Bacteria And Their Resistance Markers Class 2 PAM
§866.3365 Fungal Organisms, Nucleic Acid-Based Assay Class 2 PEO
866.3378 Mass Spectrometry, Microorganism Identification, Blood Culture Class 2 QNJ
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 Contacts
 Ribhi Shawar
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
 Courtney Chandler
  CDRH/OPEQ/OHTVII/DMD/BAC1
  --
  courtney.chandler@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.
-
-