# DEN170047: Curetis Unyvero LRT Application

- Pathway: De Novo (Direct)
- Applicant: Curetis GmbH
- Decided: Apr 3, 2018 after 204 days
- Product code: QBH (Lower Respiratory Microbial Nucleic Acid Detection System)
- Device class: 2
- Regulation: 21 CFR 866.3985
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K180966: FilmArray Pneumonia Panel (2018), 2 descendants of its own
- K212727: FilmArray Pneumonia Panel (2021), 1 descendant of its own
- K243222: BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) (2024), 0 descendants of its own
- K191967: Unyvero LRT BAL Application (2019), 0 descendants of its own

## Indications for use
The Unyvero LRT Application is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of nucleic acid sequences from the following microorganisms and antibiotic resistance markers in endotracheal aspirates from adult hospitalized patients with suspected lower respiratory tract infections. Microorganism — Associated antibiotic resistance marker Acinetobacter spp.ᵃ — ctx-Mᵇ, kpc, ndm, oxa-23, oxa-24, oxa-58, vim Chlamydia pneumoniae — Citrobacter freundii — ctx-Mᵇ, kpc, ndm, oxa-48, vim Enterobacter cloacae complexᶜ — ctx-Mᵇ, kpc, ndm, oxa-48, vim Escherichia coli — ctx-Mᵇ, kpc, ndm, oxa-48, vim Haemophilus influenzae — tem Klebsiella oxytoca — ctx-Mᵇ, kpc, ndm, oxa-48, vim Klebsiella pneumoniaeᵈ — ctx-Mᵇ, kpc, ndm, oxa-48, vim Klebsiella variicola — ctx-Mᵇ, kpc, ndm, oxa-48, vim Legionella pneumophila — Moraxella catarrhalis — Morganella morganii — ctx-Mᵇ, kpc, ndm, oxa-48, vim Mycoplasma pneumoniae — Proteus spp.ᵉ — ctx-Mᵇ, kpc, ndm, oxa-48, vim Pseudomonas aeruginosa — ctx-Mᵇ, kpc, ndm, vim Serratia marcescens — ctx-Mᵇ, kpc, ndm, oxa-48, vim Staphylococcus aureus — mecA Stenotrophomonas maltophilia — Streptococcus pneumoniae — ᵃ Acinetobacter spp. includes: A. baumannii, A. calcoaceticus, A. haemolyticus, A. junii, A. lwoffii, A. nosocomialis, A. parvus, A. pittii, (detected by LRT Application) and A. ursingii (not detected by LRT Application). ᵇ ctx-M1 subgroup. ᶜ Enterobacter cloacae complex includes: E. asburiae, E. cloacae, E. hormaechei, E. kobei, E. ludwigii, and E. xiangfangensis. ᵈ Klebsiella pneumoniae includes two variants: K. pneumoniae (variant 1), and K. quasipneumoniae (variant 2) ᵉ Proteus spp. includes P. hauseri, P. mirabilis, P. penneri and P. vulgaris. The Unyvero LRT Application performed on the Unyvero System is indicated as an aid in the diagnosis of lower respiratory tract infection in adult hospitalized patients with signs and symptoms of lower respiratory infection; results should be used in conjunction with other clinical and laboratory findings. As tracheal aspirates commonly contain colonizing microorganisms, detection of Unyvero LRT microbial targets does not indicate that the microorganism is the cause of the disease. Unyvero positive results do not rule out co-infection with microorganisms not detected by the Unyvero LRT Application. Negative results do not preclude lower respiratory infection, as the causative agent may be a microorganism not detected by this test. A negative result for any antibiotic resistance marker does not indicate that detected microorganisms are susceptible to applicable antimicrobial agents. Detected resistance markers cannot be definitively linked to specific microorganisms, and may be present in organisms that are not detected by the Unyvero LRT Application such as organisms present as colonizing or normal flora. Microbiology cultures of aspirates should be performed to obtain isolates for species identification and antimicrobial susceptibility testing, to differentiate quantities of identified microorganisms as well as normal flora present in the specimen and to identify potential microorganisms not targeted by the Unyvero LRT Application.

Source page: https://510kreport.com/device/DEN170047
Methodology: https://510kreport.com/methodology