510(k) · Cleared

Cleared

Aptima CV/TV Assay

K190472510(k) TraditionalCleared May 16, 201979-day reviewClass II21 CFR 866.3975

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hologic, Inc. · PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Cleared on May 16, 2019 as substantially equivalent to DEN160001 (Geneohm Sciences Canada, Inc. (Bd Diagnostics), 2016) after a 79-day review. Its family tree reaches back 1 generation to 2016. 1 later device descends from it.

Decided: May 16, 2019
Review: 79 days
Class: Class II
Product code: PQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN160001 (2016). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN160001 BD MAX Vaginal Panel, BD MAX InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2016
This deviceK190472 Aptima CV/TV AssayHologic, Inc. · 2019
Descendant · cites it directly · 0 of its ownK243345 Aptima BV Assay; Aptima CV/TV AssayHologic, Inc. · 2024

Most influential descendants

Showing 1 of 1 · See all

K243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc. · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN160001	BD MAX Vaginal Panel, BD MAX Instrument	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	2016	—
0 (this device)	K190472	Aptima CV/TV Assay	Hologic, Inc.	2019	—
+1	K243345	Aptima BV Assay; Aptima CV/TV Assay	Hologic, Inc.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K190472, 2016–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PQA device

#1 K260021 cobas® BV/CVscore 12.0 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN160001	BD MAX Vaginal Panel, BD MAX Instrument Summary page 4 …21 CFR 866.3975 Regulatory Class: Class II Product Code: PQA, NSU III. PREDICATE DEVICE The predicate device is the BD MAX Vaginal Panel (DEN160001; approved 10/28/2016, BD Diagnostics). IV. DEVICE DESCRIPTION The Aptima CV/TV assay is an in vitro nucleic acid amplification…	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	2016	—

Also cleared against DEN160001: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K243345	Aptima BV Assay; Aptima CV/TV Assay	Hologic, Inc.	2024	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K243345 (Hologic, Inc., 2024) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate DEN160001.

How does its category compare?

All PQA devices

PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · PQA

2in 2024

2007high 3 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PQA

87in 2019

2007high 87 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PQA

2in 2018

2007high 2 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PQA

3in 2025

2007high 7 (2022) · low 0 (2007)2025

MAUDE reports naming product code PQA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	1	—	0	0
2017	0	—	0	0
2018	0	—	2	0
2019	3	87	0	0
2020	0	—	0	2
2021	1	—	0	4
2022	2	—	0	7
2023	2	—	0	3
2024	2	—	0	5
2025	0	—	0	3
2026	2	—	0	—

What is it indicated for?

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…

Read the full statement (149 words)

• 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190472: Aptima CV/TV Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190472

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026