# K254194: QIAstat-Dx BCID GPF Plus AMR Panel

- Pathway: 510(k) (Traditional)
- Applicant: QIAGEN GmbH
- Decided: Aug 6, 2026 after 226 days
- Product code: PAM (Gram-Positive Bacteria And Their 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: 4 generations back to DEN120014 (2012). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181663: ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel, Genmark Diagnostics, Incorporated (2018) Summary page 6.
- K182690: ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel, Genmark Diagnostics, Incorporated (2018) Summary page 6.

## Indications for use
The QIAstat-Dx BCID GPF Plus AMR Panel is a qualitative multiplexed nucleic acid real-time PCR-based in vitro diagnostic test intended for use with QIAstat-Dx Analyzer 2.0. The QIAstat-Dx BCID GPF Plus AMR Panel is capable of simultaneous detection and identification of multiple gram-positive bacterial and fungal pathogens and selected genetic determinants associated with antimicrobial resistance. Additionally, the QIAstat-Dx BCID GPF Plus AMR Panel is capable of detecting a wide variety of gram-negative bacteria (Pan Gram Negative assay). The QIAstat-Dx BCID GPF Plus AMR Panel is intended for use in positive blood culture samples from patients with blood stream infections identified via Gram stain to contain gram-positive bacteria or fungi. The following gram-positive bacteria are identified and differentiated using the QIAstat-Dx BCID GPF Plus AMR Panel: • Bacillus cereus group • Corynebacterium • Enterococcus faecalis • Enterococcus faecium • Listeria monocytogenes • Micrococcus spp. • Staphylococcus aureus • Staphylococcus epidermidis • Staphylococcus lugdunensis • S. capitis/ S. hominis • Streptococcus agalactiae • Streptococcus anginosus group • Streptococcus pneumoniae • Streptococcus pyogenes The following fungi are identified and differentiated using the QIAstat-Dx BCID GPF Plus AMR Panel: • Cryptococcus neoformans/gattii • Fusarium • Candida auris The QIAstat-Dx BCID GPF Plus AMR Panel also contains targets designed to detect a broad range of organisms with a potentially misleading Gram stain result or organisms that may be missed by Gram staining altogether, for example in the case of co-infections. These include: • A broad Pan Gram Negative assay • Candida Group 1: (detects but does not differentiate 6 species) o Candida albicans o Candida tropicalis o Candida dubliniensis o Candida famata o Candida guilliermondii o Candida kefyr • Candida Group 2: (detects but does not differentiate 4 species) o Candida glabrata o Candida krusei o Candida parapsilosis o Candida lusitaniae The QIAstat-Dx BCID GPF Plus AMR Panel contains assays for the detection of the following genetic determinants associated with resistance to antimicrobial agents: • aac(6')-aph(2'') • cfr • ermA • ermC • mecA • mecC • tetK • tetM • vanA • vanB The QIAstat-Dx BCID GPF Plus AMR Panel contains assays for the detection of genetic determinants associated with resistance to gentamicin/tobramycin/kanamycin (aac(6')- aph(2''))), PhLOPSA multi-class resistance phenotype (cfr), erythromycin (ermA and ermC), methicillin (mecA and mecC), tetracycline (tetK and tetM) and vancomycin (vanA and vanB). 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 test is performed on blood culture samples identified as positive by a continuous monitoring blood culture system and gram-positive bacteria or fungi as determined by Gram stain. The QIAstat-Dx BCID GPF Plus AMR Panel is intended as an aid in diagnosis of bloodstream infections identifying specific pathogens and genetic determinants associated with resistance. Results should be used in conjunction with other clinical or laboratory information, e.g., Gram stain results. Sub-culturing of positive blood cultures is necessary for identification of organisms not detected by QIAstat-Dx BCID GPF Plus AMR Panel and susceptibility testing. Results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results do not preclude the presence of pathogens that are not detected by this test. Positive QIAstat-Dx BCID GPF Plus AMR results do not rule out infection or co-infection with organisms not included in the QIAstat-Dx BCID GPF Plus AMR Panel.

Source page: https://510kreport.com/device/K254194
Methodology: https://510kreport.com/methodology