Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 065 Date of Entry 12/22/2025 
FR Recognition Number 15-69
Standard
ASTM  F2944-20
Standard Practice for Automated Colony Forming Unit (CFU) Assays - Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
Scope/Abstract
1.1 This practice, provided its limitations are understood, describes a procedure for quantitative measurement of the number and biological characteristics of colonies derived from a stem cell or progenitor population using image analysis.

1.2 This practice is applied in an in vitro laboratory setting.
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.
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
 Judith Arcidiacono
  FDA/OC/CBER/OTP/PSPS/
  240-402-8250
  judith.arcidiacono@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Tissue Engineering
*These are provided as examples and others may be applicable.
-
-