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U.S. Department of Health and Human Services

Product Classification

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Device trichomonas vaginalis nucleic acid amplification test system
Regulation Description Trichomonas vaginalis nucleic acid assay.
Definition In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients
Physical State May include target capture, transcription-mediated amplification, semi automated analyzer
Technical Method Uses target capture, transcription-mediated amplification and hybridization protection assay technologies to stream line specimen processing, amplify target rRNA and detect amplicon respectively
Target Area Vaginal, cervical,endocervical, urogenital and gynecological specimens
Regulation Medical Specialty Immunology
Review Panel Microbiology
Product CodeOUY
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3860
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