Product Classification

• 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 Code: OUY
• 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis - Guideline for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible