510(k) · Cleared
ClearedePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genmark Diagnostics, Incorporated · PEO Fungal Organisms, Nucleic Acid-Based Assay
Cleared on Dec 21, 2018 as substantially equivalent to K130914 (Biofire Diagnostics, Inc., 2013) after an 85-day review. Its family tree reaches back 3 generations to 2012. 2 later devices descend from it.
- Decided
- Dec 21, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- PEO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN120014 (2012). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- 2 generations backK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · Recalled
- 1 generation backK130914 Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013 · Recalled
- This deviceK182690 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP)…Genmark Diagnostics, Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK254194 QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbH · 2026
- Descendant · cites it directly · 0 of its ownK240627 LIAISON PLEX Yeast Blood Culture AssayLuminex Corporation · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| −2 | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test | Nanosphere, Inc. | 2012 | 8 |
| −1 | K130914 | Filmarray Blood Culture Identification (Bcid) Panel | Biofire Diagnostics, Inc. | 2013 | 6 |
| 0 (this device) | K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | Genmark Diagnostics, Incorporated | 2018 | — |
| +1 | K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | 2026 | — |
| +1 | K240627 | LIAISON PLEX Yeast Blood Culture Assay | Luminex Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 PEO? 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 PEO device
- #1 K240627 LIAISON PLEX Yeast Blood Culture Assayscore 8.4 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K130914 | Filmarray Blood Culture Identification (Bcid) PanelSummary page 6…GenMark Diagnostics, Incorporated Predicate Device Predicate: FilmArray Blood Culture Identification Panel; BioFire Diagnostics; K130914 Device Description The ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel is based on the principles of competi… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K254194 (QIAGEN GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K130914.
How does its category compare?
All PEO devicesPEO Fungal Organisms, Nucleic Acid-Based Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PEO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PEO
Too few PEO 510(k)s in any year since 2007 to give a median.
Recalls per year · PEO
No recall names PEO since 2007.
Adverse event reports per year · PEO
2in 2025
MAUDE reports naming product code PEO, 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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GenMark ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on GenMark's ePlex Instrument for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The ePlex BCID-FP Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system…
Read the full statement (267 words)
The GenMark ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on GenMark's ePlex Instrument for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The ePlex BCID-FP Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal organism.
The following fungal organisms are identified using the ePlex BCID-FP Panel: Candida albicans, Candida auris, Candida dubliniensis, Candida famata, Candida glabrata, Candida guilliermondii, Candida kefyr, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Cryptococcus gattii, Cryptococcus neoformans, Fusarium and Rhodotorula.
The detection and identification of specific fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from the ePlex BCID-FP Panel are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the ePlex BCID-FP Panel may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by ePlex BCID-FP Panel, susceptibility testing and differentiation of mixed growth) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection.
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/K182690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182690: ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182690
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026