K151589 is an FDA 510(k) clearance for the BD MAX CT/GC/TV, BD MAX INSTRUMENT. This device is classified as a Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II - Special Controls, product code OUY).
Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on September 6, 2016, 452 days after receiving the submission on June 12, 2015.
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 | K151589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2015 |
| Decision Date | September 06, 2016 |
| Days to Decision | 452 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 |