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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 7-273
CLSI M58 1st Edition
Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
This guideline includes performance, reporting, and quality assurance recommendations for the identification of cultured microorganisms by medical laboratory professionals using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. Recommendations for end-user verification and workflow integration are also included.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.3361 System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Class 2 PEX
21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studie
21 CFR 866 Immunology and Microbiology Devices
Relevant FDA Guidance and/or Supportive Publications*
CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition.

CLSI EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition.

CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Third Edition.

CLSI MM18-A Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline.

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
 Yvonne Shea
 Stephanie Krmenec
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.