510(k) K190452
K190452 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Aptima BV Assay". The FDA issued a decision of Substantially Equivalent on May 23, 2019. The device falls under product code PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System), a Class II device regulated under 21 CFR 866.3975. Hologic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2019
- Date Received
- February 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- Device Class
- Class II
- Regulation Number
- 866.3975
- Review Panel
- MI
- Submission Type
A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.