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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 040 Date of Entry 08/14/2015 
FR Recognition Number 7-255
Standard
CLSI  MM09-A2 (Replaces MM09-A)
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition
Scope/Abstract
Sequencing methods for genotyping have moved from the research laboratory into the clinical laboratory. Sequencing is an assay format of choice for very high-complexity genotyping, especially when hundreds or thousands of bases of genetic sequence are analyzed. Clinical and Laboratory Standards Institute document MM09-A2-Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline-Second Edition addresses diagnostic sequencing using both automated capillary electrophoresis sequencers and massively parallel sequencing instruments. Topics covered include specimen collection and handling; isolation and extraction of nucleic acid; template preparation; sequence generation, alignment, and assembly; validation and verification; ongoing QA; and reporting results.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 9.2,
Section 12.1, and
Section 10.1.3.3 Assay Validation.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.2265 High throughput genomic sequence analyzer for clinical use.
§862.2570 Dna Genetic Analyzer Class 2 PCA
§866.5900 System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection Class 2 PFR
§866.5900 System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection Class 2 PFS
§886.1930 Calibrator, Tonometer Class 2 HLA
N/A Test, Qualitative, For Hla, Non-Diagnostic MZI
Relevant FDA Guidance and/or Supportive Publications*
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
 Sharon (Xueying) Liang
  FDA/OMPT/CDRH/OIR/DMGP/MGB/
  301-796-9601
  sharon.liang@fda.hhs.gov
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.
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