510(k) · Cleared

Cleared

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

K212213510(k) TraditionalCleared Feb 9, 2022209-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

Cepheid · PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Cleared on Feb 9, 2022 as substantially equivalent to K191957 (Geneohm Sciences Canada, Inc. (Bd Diagnostics), 2019) after a 209-day review. Its family tree reaches back 2 generations to 2016. 2 later devices descend from it.

Decided: Feb 9, 2022
Review: 209 days
Class: Class II
Product code: PQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to DEN160001 (2016). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backDEN160001 BD MAX Vaginal Panel, BD MAX InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2016
1 generation backK191957 BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2019
This deviceK212213 Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid · 2022
Descendant · cites it directly · 1 of its ownK221160 Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid · 2022
Descendant · 2 generations on · 0 of its ownK231381 Xpert Xpress MVP; GeneXpert Xpress SystemCepheid · 2023

Most influential descendants

Showing 2 of 2 · See all

K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid · 2022 · cites it directly1descendant
K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN160001	BD MAX Vaginal Panel, BD MAX Instrument	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	2016	—
−1	K191957	BD MAX Vaginal Panel	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	2019	—
0 (this device)	K212213	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System	Cepheid	2022	—
+1	K221160	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System	Cepheid	2022	—
+2	K231381	Xpert Xpress MVP; GeneXpert Xpress System	Cepheid	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0
2023	1	0

FIG. 1 — Lineage of K212213, 2016–2023Source: 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
*	K191957	BD MAX Vaginal Panel Summary page 6 …System, OOI Classification Microbiology (83) Advisory Panel Prescription Use Yes Predicate Device BD MAX Vaginal Panel (K191957) Assay: Xpert® Xpress MVP Traditional 510(k) Submission 5…	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	2019	—

Also cleared against K191957: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K221160	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System	Cepheid	2022	1

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?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K221160 (Cepheid, 2022) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K191957.

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. 2022, 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?

Read the full statement (177 words)

The Xpert Xpress MVP test, performed on the GeneXpert Instrument Systems, is an automated qualitative in vitro diagnostic test for the detection of DNA targets from anaerobic bacteria associated with bacterial vaginosis (BV), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis. The Xpert Xpress MVP test uses clinician-collected and self-collected vaginal swabs (collected in a clinical setting) from patients who are symptomatic for vaginitis/vaginosis. The Xpert Xpress MVP test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:

• Organisms associated with bacterial vaginosis (detected organisms not reported individually)

o Atopobium spp. (Atopobium vaginae, Atopobium novel species CCUG 55226)

o Bacterial Vaginosis-Associated Bacterium 2 (BVAB2)

o Megasphaera-1

• Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis, species not differentiated)

• Candida glabrata/Candida krusei (species not differentiated)

• Trichomonas vaginalis

The Xpert Xpress MVP test is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis, or trichomoniasis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K212213 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212213: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212213

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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