510(k) · Cleared
ClearedQIAstat-Dx BCID GPF Plus AMR Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
QIAGEN GmbH · PAM Gram-Positive Bacteria And Their Resistance Markers
Cleared on Aug 6, 2026 as substantially equivalent to K181663 (Genmark Diagnostics, Incorporated, 2018) and 1 other predicate after a 226-day review. Its family tree reaches back 4 generations to 2012.
- Decided
- Aug 6, 2026
- Review
- 226 days
- Class
- Class II
- Product code
- PAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN120014 (2012). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- 3 generations backK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · Recalled
- 2 generations backK130914 Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013 · Recalled
- 1 generation backK181663 ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP)…Genmark Diagnostics, Incorporated · 2018
- This deviceK254194 QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| −3 | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test | Nanosphere, Inc. | 2012 | 8 |
| −2 | K130914 | Filmarray Blood Culture Identification (Bcid) Panel | Biofire Diagnostics, Inc. | 2013 | 6 |
| −1 | K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Genmark Diagnostics, Incorporated | 2018 | — |
| 0 (this device) | K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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 PAM? 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 PAM device
- #1 K243490 LIAISON PLEX Gram-Positive Blood Culture Assayscore 9.8 · 2 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelSummary page 6…510(k) No. ePlex Blood Culture Identification Gram Positive (BCID-GP) Panel K181663 (Primary Predicate) ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel K182690 August 05, 2026 ==… | 2018 |
| * | K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelSummary page 6…K181663 (Primary Predicate) ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel K182690 August 05, 2026 QIAGEN 510(k) Premarket Notificat… | 2018 |
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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All PAM devicesPAM Gram-Positive Bacteria And Their 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 · PAM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAM
Too few PAM 510(k)s in any year since 2007 to give a median.
Recalls per year · PAM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAM
75in 2025
MAUDE reports naming product code PAM, 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 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 3 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 106 |
| 2024 | 0 | — | 0 | 422 |
| 2025 | 1 | — | 0 | 75 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (569 words)
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.
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/K254194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254194: QIAstat-Dx BCID GPF Plus AMR Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254194
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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