Aptima BV Assay
FDA 510(k) clearance K190452 · decided 2019-05-23
Clearance details
- K-number
- K190452
- Device name
- Aptima BV Assay
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-25
- Decision date
- 2019-05-23
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PQA
- Device class
- 2
- Regulation number
- 866.3975
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
| BD Vaginal Panel (K243725) | Becton, Dickinson and Company | 2024-12-19 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Xpert Xpress MVP; GeneXpert Xpress System (K231381) | Cepheid | 2023-10-19 |
| BD Vaginal Panel (K223653) | Becton, Dickinson and Company | 2023-03-06 |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K221160) | Cepheid | 2022-06-07 |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K212213) | Cepheid | 2022-02-09 |
| BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (K201017) | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021-10-18 |
| BD MAX Vaginal Panel (K191957) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019-10-21 |
| Aptima CV/TV Assay (K190472) | Hologic, Inc. | 2019-05-16 |
| BD MAX Vaginal Panel, BD MAX Instrument (DEN160001) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016-10-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NovaSure Model 10 RF Controller (P010013/S094) | Hologic, Inc. | 2025-12-17 |
| Envision Mammography Platform (P080003/S011) | Hologic, Inc. | 2025-11-24 |
| Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe (P170025/S023) | Hologic, Inc. | 2025-10-07 |
| ThinPrep Processor and ThinPrep Imaging System (P950039/S041) | Hologic, Inc. | 2025-08-27 |
| Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System (P920048/S027) | Hologic, Inc. | 2024-12-06 |
| TLiIQ QCette (P920048/S026) | Hologic, Inc. | 2024-10-23 |
| Aptima CMV Quant Assay (P210029/S002) | Hologic, Inc. | 2024-10-23 |
| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |