K182692 is an FDA 510(k) clearance for the BD MAX CTGCTV2, BD MAX System. 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 January 8, 2019, 103 days after receiving the submission on September 27, 2018.
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 | K182692 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2018 |
| Decision Date | January 08, 2019 |
| Days to Decision | 103 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 |