K143329 is an FDA 510(k) clearance for the AmpliVue Trichomonas Assay. This device is classified as a Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II - Special Controls, product code OUY).
Submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on March 17, 2015, 117 days after receiving the submission on November 20, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3860. 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.
| 510(k) Number | K143329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2014 |
| Decision Date | March 17, 2015 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OUY — Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3860 |
| 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 |