| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
047
|
Date of Entry 08/21/2017
|
|
FR Recognition Number
|
7-273
|
| Standard | |
CLSI M58 1st Edition
Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry |
|
Scope/Abstract| 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
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
|
| *These are provided as examples and others may be applicable. |
