# K190452: Aptima BV Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: May 23, 2019 after 87 days
- Product code: PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System)
- Device class: 2
- Regulation: 21 CFR 866.3975
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160001 (2016). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160001: BD MAX Vaginal Panel, BD MAX Instrument, Geneohm Sciences Canada, Inc. (Bd Diagnostics) (2016) Summary page 3.

## Most influential descendants
- K243345: Aptima BV Assay; Aptima CV/TV Assay (2024), 0 descendants of its own

## Indications for use
The Aptima BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. The assay reports a qualitative result for BV and does not report results for individual organisms. The assay is intended to aid in the diagnosis of BV on the automated Panther system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.

Source page: https://510kreport.com/device/K190452
Methodology: https://510kreport.com/methodology