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U.S. Department of Health and Human Services

Product Classification

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Device hiv-1 genotyping assay using ngs technology
Definition The human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology is a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific anti-retroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection.
Physical State Automated instrument, liquid handling, software interfaces, software, primers, reagents, buffers, bioinformatics pipeline, genomic databases
Technical Method Nucleic acid extraction, amplification, next generation sequencing, bioinformatics, alignment, results interpretation
Target Area Whole blood, plasma
Regulation Medical Specialty Molecular Genetics
Review Panel Microbiology
Product CodeQIC
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 866.3955
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible