# K191967: Unyvero LRT BAL Application

- Pathway: 510(k) (Traditional)
- Applicant: Curetis GmbH
- Decided: Dec 20, 2019 after 150 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
Longest line of descent: 1 generation back to DEN170047 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170047: Curetis Unyvero LRT Application, Curetis GmbH (2018) Summary page 5.

## Indications for use
The Unyvero LRT BAL Application is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of nucleic acid sequences from the following microorganisms (N = 20) and antibiotic resistance markers (N = 10) in bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) from adult hospitalized patients with suspected lower respiratory tract infections. Microorganism Associated Antibiotic Resistance Marker Acinetobacter spp. a ctx-M b, kpc, ndm, oxa-23, oxa-24, oxa-58, vim Chlamydia pneumoniae - Citrobacter freundii ctx-M b, kpc, ndm, oxa-48, vim Enterobacter cloacae complex c ctx-M b, kpc, ndm, oxa-48, vim Escherichia coli ctx-M b, kpc, ndm, oxa-48, vim Haemophilus influenzae tem Klebsiella oxytoca ctx-M b, kpc, ndm, oxa-48, vim Klebsiella pneumoniae d ctx-M b, kpc, ndm, oxa-48, vim Klebsiella variicola ctx-M b, kpc, ndm, oxa-48, vim Legionella pneumophila - Moraxella catarrhalis - Morganella morganii ctx-M b, kpc, ndm, oxa-48, vim Mycoplasma pneumoniae - Pneumocystis jirovecii - Proteus spp. e ctx-M b, kpc, ndm, oxa-48, vim Pseudomonas aeruginosa ctx-M b, kpc, ndm, vim Serratia marcescens ctx-M b, 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 BAL Application) and A. ursingii (not detected by LRT BAL Application). b ctx-M1 subgroup. c Enterobacter cloacae complex includes: E. asburiae, E. chengduensis, E. chuandaensis, E. cloacae, E. hormaechei (incl. ssp. xiangfangensis), E. kobei, E. ludwigii, E. roggenkampii, E. sichuanensis as well as E. bugandensis (not yet recognized as member of the E. cloacae complex). d Klebsiella pneumoniae includes two variants: K. pneumoniae (variant 1), and K. quasipneumoniae (variant 2). e Proteus spp. includes P. cibarius, P. hauseri, P. mirabilis, P. penneri and P. vulgaris. The Unyvero LRT BAL 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 BAL specimens may contain colonizing microorganisms, detection of Unyvero LRT BAL microbial targets does not indicate that the microorganism is the cause of the disease. Unyvero positive results do not rule out co-infection with other microorganisms. 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 antibiotic resistance markers cannot be definitively linked to specific microorganisms, and may be present in organisms that are not detected by the Unyvero LRT BAL Application. Microbiology cultures of BALs should be performed to obtain isolates for species identification and antimicrobial susceptibility testing and to identify potential microorganisms not targeted by the Unyvero LRT BAL Application.

Source page: https://510kreport.com/device/K191967
Methodology: https://510kreport.com/methodology