# K243345: Aptima BV Assay; Aptima CV/TV Assay

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Nov 25, 2024 after 28 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: 2 generations back to DEN160001 (2016). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190452: Aptima BV Assay, Hologic, Inc. (2019) Summary page 5.
- K190472: Aptima CV/TV Assay, Hologic, Inc. (2019) Summary page 12.

## Indications for use
Aptima BV Assay The Aptima BV Assay is an in vitro nucleic acid amplification test that utilizes real time Transcription-Mediated Amplification (TMA) technology 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 (G. vaginalis), and Atopobium vaginae (A. 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. Aptima CV/TV Assay The Aptima CV/TV Assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real time Transcription-Mediated Amplification (TMA) technology to detect and qualitatively report results for the following organisms: • Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) • Candida glabrata (C. glabrata) • Trichomonas vaginalis (TV) The assay differentiates between C. glabrata and the Candida species group (C spp) by targeting the RNA component of RNAse P ribonucleoprotein; the assay does not differentiate among C spp. For TV, the assay targets ribosomal RNA (rRNA) and differentiates the result from results for C. glabrata and C spp. The assay is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis on the automated Panther System using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis or vulvovaginitis.

Source page: https://510kreport.com/device/K243345
Methodology: https://510kreport.com/methodology