K161182 is an FDA 510(k) clearance for the Solana 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 August 15, 2016, 110 days after receiving the submission on April 27, 2016.
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 | K161182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2016 |
| Decision Date | August 15, 2016 |
| Days to Decision | 110 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 |