K161619 is an FDA 510(k) clearance for the Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems. This device is classified as a Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II - Special Controls, product code OUY).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on August 29, 2016, 77 days after receiving the submission on June 13, 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 | K161619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2016 |
| Decision Date | August 29, 2016 |
| Days to Decision | 77 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 |