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/AbstractThis 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
|
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FDA recognition of CLSI M47-A (Replaces M47-P) [Rec# 7-189] will be superseded by recognition of CLSI M47 2nd Edition [Rec# 7-322].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
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |