| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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7-289
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| Standard | |
CLSI MM17 2nd Edition
Verification and Validation of Multiplex Nucleic Acid Assays |
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Scope/Abstract| This document discusses analytical validation and verification of qualitative multiplex nucleic acid assays. Topics covered include sample preparation, a general discussion of multiplex methods and technologies, reference and quality control materials, data analysis, and results reporting. Clinical validity and utility are briefly reviewed. Because of the variety and breadth of multiplex testing, specific protocols for validation and verification are not included. However, detailed recommendations for appropriate analytical validation and verification, based on the most current guidance documents, are provided. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Chapter 2.4 Validation and Verification Protocols
Chapter 2.5 Analytical Validation of a Laboratory-Developed Test
Chapter 2.6 Analytical Validation of a Modified In Vitro Diagnostic Assay
Chapter 2.7 Verification of an In Vitro Diagnostic Assay
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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.
Standard is recognized on a scientific basis: Device performance.
Chapter 2.4 does not satisfy the requirement for analytical performance characteristics under 21 CFR 809.10(b)(12) Specific Performance Characteristics and 21 CFR 807.87 because it describes requirements for validation and verification in clinical laboratories and not for submitters of premarket submissions to establish IVD performance for marketing purposes.
Chapter 2.5, Chapter 2.6 and Chapter 2.7 does not satisfy the requirement for analytical performance characteristics under 21 CFR 809.10(b)(12) Specific Performance Characteristics and 21 CFR 807.87 because it was developed for clinical laboratories and 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 |
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Relevant FDA Guidance and/or Supportive Publications*
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses Guidance for Industry and Food and Drug Administration Staff, Issued September 2017.
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 Contacts
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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. |
