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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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 Mass spectrometer system for clinical use for the identification of microorganisms.
21 CFR Part 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 Contact
 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.