510(k) · Cleared
Recalled · Class II · 2020Filmarray Blood Culture Identification (Bcid) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, Inc. · PEN Gram-Negative Bacteria And Associated Resistance Markers
Cleared on Jun 21, 2013 as substantially equivalent to K122514 (Nanosphere, Inc., 2012) after an 80-day review. Its family tree reaches back 2 generations to 2012. 9 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 21, 2013
- Review
- 80 days
- Class
- Class II
- Product code
- PEN
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN120014 (2012). 9 later devices descend from it, 4 citing it directly.
- Root · 2 generations backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- 1 generation backK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · Recalled
- This deviceK130914 Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK182690 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP)…Genmark Diagnostics, Incorporated · 2018
- Descendant · cites it directly · 2 of its ownK132843 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 2014 · Recalled
- Descendant · cites it directly · 1 of its ownK181663 ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP)…Genmark Diagnostics, Incorporated · 2018
- Descendant · cites it directly · 1 of its ownK143171 FilmArray Blood Culture Identification (BCID) Panel for use with the…Biofire Diagnostics, LLC · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK254194 QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbH · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelGenmark Diagnostics, Incorporated · 2018 · cites it directly2descendants
- K132843Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 2014 · cites it directly2descendants
- K181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelGenmark Diagnostics, Incorporated · 2018 · cites it directly1descendant
- K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · cites it directly1descendant
- K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbH · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| −1 | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test | Nanosphere, Inc. | 2012 | 8 |
| 0 (this device) | K130914 | Filmarray Blood Culture Identification (Bcid) Panel | Biofire Diagnostics, Inc. | 2013 | — |
| +1 | K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | Genmark Diagnostics, Incorporated | 2018 | — |
| +1 | K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) | Nanosphere, Inc. | 2014 | 8 |
| +1 | K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Genmark Diagnostics, Incorporated | 2018 | — |
| +1 | K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray… | Biofire Diagnostics, LLC | 2015 | 5 |
| +2 | K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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 K262168 QIAstat-Dx BCID GN Plus AMR Panelscore 12.1 · 1 generation · 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 |
|---|---|---|---|
| * | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestSummary page 1…egulation Number: 21 CFR 866.3365 Classification Name: Multiplex devices that use DNA hybridization to detect bacteria and their resistance markers Predicate DC\"ice: K 122514 - Nanosphere Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC- BG) : Intended Use: The FilmArray Blood Culture Ident… | 2012 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | 2018 | 2 |
| K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) | 2014 | 2 |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | 2018 | 1 |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 22, 2020 | Class II | Z-2296-2020 | Under Investigation by firm | There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive… |
| Jan 22, 2020 | Class II | Z-2295-2020 | Under Investigation by firm | There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive… |
| Mar 7, 2019 | Class II | Z-1133-2019 | Material/Component Contamination | Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles. |
| Sep 5, 2018 | Class II | Z-0296-2019 | Material/Component Contamination | Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles. |
| Mar 14, 2018 | Class II | Z-1513-2018 | Material/Component Contamination | There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles. |
| May 27, 2014 | Class II | Z-1843-2014 | Labeling design | BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioM¿rieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False positive results have… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 9 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K182690 (Genmark Diagnostics, Incorporated, 2018) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K122514.
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. 2013, 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 FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the FilmArray Instrument. The FilmArray BCID Panel is capable of simultaneous detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance. The BCID assay is performed directly on blood culture samples identified as positive by a…
Read the full statement (356 words)
The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the FilmArray Instrument. The FilmArray BCID Panel is capable of simultaneous detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance. The BCID assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain.
The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: Enterococci, Listeria monocytogenes, commonly encountered Staphylococci (including specific differentiation of Staphylococcus aureus), commonly encountered Streptococci (with specific differentiation of Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes), Acinetobacter baumannii, commonly encountered Enterobacteriaceae (including specific differentiation of the Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens), Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, and Candida tropicalis.
The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (mec4), vancomycin (vand and vanB), and carbapenems (blakpc) to aid in the identification of potentially antimicrobial resistant organisms in positive blood culture samples. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, and carbapenems exist.
FilmArray BCID is indicated as an aid in the diagnosis of specific agents of bacteremia and fungemia and results should be used in conjunction with other clinical and laboratory findings. Positive FilmArray results do not rule out co-infection with organisms not included in the FilmArray BCID Panel. FilmArray BCID is not intended to monitor treatment for bacteremia or fungemia.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not detected by the FilmArray BCID Panel, and for species determination of some Staphylococci, Enterococci, Streptococci, and Enterobacteriaceae that are not specifically identified by the FilmArray BCID Panel assays.
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/K130914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130914: Filmarray Blood Culture Identification (Bcid) Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130914
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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