# K190472: Aptima CV/TV Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: May 16, 2019 after 79 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 4.

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

## Indications for use
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) to detect and qualitatively report results for the following organisms: • Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) • Candida glabrata • Trichomonas vaginalis The assay differentiates between Candida 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 Trichomonas vaginalis, the assay targets ribosomal RNA (rRNA) and differentiates the result from results for Candida 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/K190472
Methodology: https://510kreport.com/methodology