# K221160: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

- Pathway: 510(k) (Special)
- Applicant: Cepheid
- Decided: Jun 7, 2022 after 47 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: 3 generations back to DEN160001 (2016). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212213: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System, Cepheid (2022) Summary page 6.

## Most influential descendants
- K231381: Xpert Xpress MVP; GeneXpert Xpress System (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K221160
Methodology: https://510kreport.com/methodology