510(k) · Cleared
ClearedQIAstat-Dx BCID GN Plus AMR Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
QIAGEN GmbH · PEN Gram-Negative Bacteria And Associated Resistance Markers
Cleared on Sep 24, 2026 as substantially equivalent to K182619 (Genmark Diagnostics, Incorporated, 2019) after a 90-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Sep 24, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- PEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K182619 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK182619 ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated · 2019
- This deviceK262168 QIAstat-Dx BCID GN Plus AMR PanelQIAGEN GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated | 2019 | — |
| 0 (this device) | K262168 | QIAstat-Dx BCID GN Plus AMR Panel | QIAGEN GmbH | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PEN device
- #1 K243013 LIAISON PLEX Gram-Negative Blood Culture Assayscore 10.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelSummary page 6…510(k) No. ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel K182619 September 24, 2026 QIAGEN CONFIDENTIAL Additional… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K182619.
How does its category compare?
All PEN devicesPEN Gram-Negative Bacteria And Associated Resistance Markers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PEN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEN
Too few PEN 510(k)s in any year since 2007 to give a median.
Recalls per year · PEN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEN
13in 2025
MAUDE reports naming product code PEN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 1 | 4 |
| 2021 | 0 | — | 1 | 15 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (450 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262168: QIAstat-Dx BCID GN Plus AMR Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262168
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026