# K262168: QIAstat-Dx BCID GN Plus AMR Panel

- Pathway: 510(k) (Traditional)
- Applicant: QIAGEN GmbH
- Decided: Sep 24, 2026 after 90 days
- Product code: PEN (Gram-Negative Bacteria And Associated Resistance Markers)
- Device class: 2
- Regulation: 21 CFR 866.3365
- 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 K182619 (2019). 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)
- K182619: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel, Genmark Diagnostics, Incorporated (2019) Summary page 6.

## Indications for use
The QIAstat-Dx BCID GN Plus AMR Panel is an automated qualitative multiplexed real-time PCR-based in vitro diagnostic test intended for use with the QIAstat-Dx Analyzer 2.0. The QIAstat-Dx BCID GN Plus AMR Panel is capable of simultaneous detection and identification of multiple gram-negative bacterial targets and selected genetic determinants associated with antimicrobial resistance. The following gram-negative bacteria are identified and differentiated using the QIAstat-Dx BCID GN Plus AMR Panel: • Acinetobacter calcoaceticus-baumannii complex • Bacteroides fragilis • Enterobacter spp. • Escherichia coli • Haemophilus influenzae • Klebsiella spp. • Neisseria meningitidis (encapsulated) • Proteus spp. • Pseudomonas aeruginosa • Salmonella spp. • Serratia spp. • Stenotrophomonas maltophilia • Pan Enterobacterales The QIAstat-Dx BCID GN Plus AMR Panel contains assays for the detection of the following genetic determinants of resistance: • aac(6’)-lb • ampC (CMY/LAT/DHA/FOX) • armA • CTX-M • GES • IMP • KPC • NDM • OXA-23 • OXA-24/40 • OXA-48-like • OXA-58 • PER • SHV • SPM • TEM • VEB • VIM The QIAstat-Dx BCID GN Plus AMR Panel contains assays for the detection of genetic determinants associated with resistance to aminoglycosides (aac(6')-lb and armA), penicillins and cephalosporins (ampC [CMY/LAT/DHA/FOX], CTX-M, GES, PER, SHV, TEM, and VEB), and carbapenems (GES, IMP, KPC, NDM, OXA-23, OXA-24/40, OXA-48-like, OXA-58, SPM, and VIM). The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease. Negative results for certain antimicrobial resistance assays do not indicate susceptibility, as multiple mechanisms of resistance exist. The QIAstat-Dx BCID GN Plus AMR Panel is intended for use in patients suspected of having bacterial infections identified as gram-negative via Gram stain in positive blood culture samples. The test is performed on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrates the presence of gram-negative bacteria via Gram stain. The QIAstat-Dx BCID GN Plus AMR Panel is intended to aid in the diagnosis of specific pathogens of bloodstream infection and select determinants of antimicrobial-resistance. Results should be used in conjunction with additional laboratory testing, e.g. sub-culturing of positive blood cultures for identification of organisms not detected by QIAstat-Dx BCID GN Plus AMR Panel and susceptibility testing and clinical presentation must be taken into consideration for patient management decisions. Negative results do not preclude the presence of pathogens that are not detected by this test. Positive QIAstat-Dx BCID GN Plus AMR Panel results do not rule out infection or co-infection with organisms not included in the QIAstat-Dx BCID GN Plus AMR Panel. Negative AMR results do not preclude the presence of other antimicrobial resistance mechanisms, and the absence of a resistance gene does not necessarily predict susceptibility to a particular drug nor predict therapeutic failure.

Source page: https://510kreport.com/device/K262168
Methodology: https://510kreport.com/methodology