| CLSI MM09-A2 (Replaces MM09-A) Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 7-255 |
| Extent | 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. |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Sharon (Xueying) Liang FDA/OMPT/CDRH/OIR/DMGP/MGB/ 301-796-9601 sharon.liang@fda.hhs.gov |
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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.
| Regulation Number | Device Name | Device Class | Product Code |
| §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 |
| §862.2570 | Dna Genetic Analyzer | Class 2 | PCA |
| §862.2265 | High Throughput Dna Sequence Analyzer | Class 2 | PFF |
| Unclassified | Test, Qualitative, For Hla, Non-Diagnostic | MZI | |
| §886.1930 | Calibrator, Tonometer | Class 2 | HLA |
| There is no relevant guidance developed at this time. |