Aptima BV Assay; Aptima CV/TV Assay
FDA 510(k) K243345 · Hologic, Inc.
510(k) numberK243345
Submission
- Device name
- Aptima BV Assay; Aptima CV/TV Assay
- Applicant
- Hologic, Inc.
San Diego, CA, US - Received
- October 28, 2024
- Decision date
- November 25, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PQA – Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3975
- Specialty
- Microbiology
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.
Other 510(k)s with product code PQA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260021 | cobas® BV/CVPQA · Traditional | Roche Molecular Systems, Inc. | 07/16/2026SE |
| K243725 | BD Vaginal PanelPQA · Special | Becton, Dickinson and Company | 12/19/2024SE |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress SystemPQA · Dual Track | Cepheid | 10/19/2023SE |
| K223653 | BD Vaginal PanelPQA · Traditional | Becton, Dickinson and Company | 03/06/2023SE |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA · Special | Cepheid | 06/07/2022SE |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA · Traditional | Cepheid | 02/09/2022SE |
| K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitPQA · Traditional | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 10/18/2021SE |
| K191957 | BD MAX Vaginal PanelPQA · Traditional | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 10/21/2019SE |
| K190452 | Aptima BV AssayPQA · Traditional | Hologic, Inc. | 05/23/2019SE |
| K190472 | Aptima CV/TV AssayPQA · Traditional | Hologic, Inc. | 05/16/2019SE |
More from Hologic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254090 | I-View®MUE · Traditional | 09/02/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | 08/12/2026SE |
| K253634 | CoolSeal Generator® (CSL-200-90)GEI · Traditional | 06/17/2026SE |
| K251993 | Panther Fusion GI Expanded Bacterial AssayPCH · Traditional | 09/25/2025SE |
| K251868 | Panther Fusion GI Bacterial AssayPCH · Traditional | 09/25/2025SE |
| K243341 | Genius AI Detection 2.0QDQ · Traditional | 07/31/2025SE |
| K243396 | Aptima SARS-CoV-2 AssayQQX · Traditional | 02/13/2025SE |
| K243935 | Aptima CMV Quant AssayPAB · Special | 01/17/2025SE |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assayQOF · Traditional | 11/15/2024SE |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional | 07/25/2024SE |
Questions and answers
When was Aptima BV Assay; Aptima CV/TV Assay cleared by the FDA?
Aptima BV Assay; Aptima CV/TV Assay (K243345) received a 510(k) decision of Substantially Equivalent on November 25, 2024, 28 days after the submission was received.
What is the product code of K243345?
The FDA product code is PQA – Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System, a Class II (moderate risk) device regulated under 21 CFR 866.3975.