| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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062
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Date of Entry 05/29/2024
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FR Recognition Number
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7-321
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| Standard | |
CLSI MM24 1st Edition
Molecular Methods for Genotyping and Strain Typing of Infectious Organisms |
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Scope/Abstract| This guideline examines the biology behind molecular strain typing and genotyping, as well as characterization and validation of these systems. It also provides recommendations regarding criteria to be considered for design, validation, and determination of clinical utility of such testing. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Chapter 5 Validation and Verification
Chapter 6 Interpreting and Reporting Data
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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.
This standard is recognized in part because:
Chapter 5 and Chapter 6 do not satisfy the requirement for analytical performance characteristics under 21 CFR 809.10(b)(12) Specific Performance Characteristics and 21 CFR 807.87 Information Required in a Premarket Notification Submission because these chapters describe requirements for validation, verification, and interpretation in clinical laboratories but not for submitters of premarket submissions to establish IVD performance for marketing purposes. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| 21 CFR 809.10(b)(12) |
| 21 CFR 807.87 |
| 21 CFR 866 Immunology and Microbiology Devices |
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Relevant FDA Guidance and/or Supportive Publications*
1. CLSI MM03 3rd Edition Molecular Diagnostic Methods for Infectious Diseases.
2. CLSI MM06-A2 Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition.
3. CLSI MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline - Second Edition.
4. CLSI MM12 Diagnostic Nucleic Acid Microarrays; Approved Guideline - First Edition.
5. CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods.
6. CLSI MM14 Design of Molecular Proficiency Testing/External Quality Assessment; Approved Guideline - Second Edition.
7. CLSI MM17 2nd Edition Validation and Verification of Multiplex Nucleic Acid Assays.
8. CLSI MM18 2nd Edition Interpretive Criteria for Identification of Bacteria and Fungi by Targeted DNA Sequencing.
9. CLSI MM22 1st Edition Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline.
10. GP17 3rd Edition Clinical Laboratory Safety; Approved Guideline.
11. M29 4th Edition Protection of Laboratory Workers from Occupationally Acquired Infections.
12. M58 1st Edition Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
