510(k) K231316
K231316 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Aptima Trichomonas vaginalis Assay". The FDA issued a decision of Substantially Equivalent on November 6, 2023. The device falls under product code OUY (Trichomonas Vaginalis Nucleic Acid Amplification Test System), a Class II device regulated under 21 CFR 866.3860. Hologic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2023
- Date Received
- May 8, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trichomonas Vaginalis Nucleic Acid Amplification Test System
- Device Class
- Class II
- Regulation Number
- 866.3860
- Review Panel
- MI
- Submission Type
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