510(k) · Cleared
Recalled · Class II · 2024BioFire Blood Culture Identification 2 (BCID2) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, LLC · PEN Gram-Negative Bacteria And Associated Resistance Markers
Cleared on Mar 18, 2020 as substantially equivalent to K181493 (Biofire Diagnostics, LLC, 2018) after a 90-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Mar 18, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- PEN
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 1 generation to K181493 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK181493 FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC · 2018 · Recalled
- This deviceK193519 BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC · 2020
- Descendant · cites it directly · 0 of its ownK243759 BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147…Biofire Diagnostics, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)…Biofire Diagnostics, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K181493 | FilmArray Blood Culture Identification (BCID) Panel | Biofire Diagnostics, LLC | 2018 | 6 |
| 0 (this device) | K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | Biofire Diagnostics, LLC | 2020 | — |
| +1 | K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)… | Biofire Diagnostics, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K181493 | FilmArray Blood Culture Identification (BCID) PanelSummary page 5…866.3365 Classification Name: Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. Predicate Device: K181493 – FilmArray® Blood Culture Identification (BCID) Panel Intended Use: The BioFire® Blood Culture Identification 2 (BCID2) Panel… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2024 | Class II | Z-2456-2024 | Device Design | If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens… |
| Jan 26, 2024 | Class II | Z-1139-2024 | Under Investigation by firm | Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums |
| Oct 17, 2023 | Class II | Z-0451-2024 | Process control | Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some… |
| Feb 1, 2023 | Class II | Z-1251-2023 | Environmental control | Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays. |
| Oct 11, 2021 | Class II | Z-0312-2022 | Material/Component Contamination | Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials. |
| May 10, 2021 | Class II | Z-1903-2021 | Process control | Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel. |
| Jan 26, 2021 | Class II | Z-1158-2021 | Other | The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K243759 (Biofire Diagnostics, LLC, 2024) has gone furthest, with 0 descendants of its own.
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. 2020, 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 BioFire® Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous…
Read the full statement (468 words)
The BioFire® Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The following organism types and subtypes are identified using the BioFire BCID2 Panel:
Gram Positive Bacteria
• Enterococcus faecalis
• Staphylococcus spp.
• Streptococcus spp.
• Enterococcus faecium
• Staphylococcus aureus
• Streptococcus agalactiae (Group B)
• Listeria monocytogenes
• Staphylococcus epidermidis
• Streptococcus pneumoniae
• Staphylococcus lugdunensis
• Streptococcus pyogenes (Group A)
Gram Negative Bacteria
• Acinetobacter calcoaceticus-baumannii complex
• Enterobacterales
• Bacteroides fragilis
• Enterobacter cloacae complex
• Haemophilus influenza
• Escherichia coli
• Neisseria meningitidis (encapsulated)
• Klebsiella aerogenes
• Pseudomonas aeruginosa
• Klebsiella oxytoca
• Stenotrophomonas maltophilia
• Klebsiella pneumoniae group
• Proteus spp.
• Salmonella spp.
• Serratia marcescens
Yeast
• Candida albicans
• Candida krusei
• Cryptococcus neoformans/gattii
• Candida auris
• Candida parapsilosis
• Candida glabrata
• Candida tropicalis
The BioFire BCID2 Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA/C and mecA/C in conjunction with MREJ), vancomycin (vanA and vanB), ß-lactams including penicillins, cephalosporins, monobactams, and carbapenems (blaCTX-M, blaIMP, blaKPC, blaNDM, blaOXA48-like, blaVIM) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the detection of the mobilized genetic determinant mcr-1, an emerging marker of public health importance. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, ß-lactams, and colistin exist.
Antimicrobial Resistance Genes
• CTX-M
• KPC
• mecA/C
• NDM
• vanA/B
• IMP
• mcr-1
• mecA/C and MREJ (MRSA)
• OXA-48-like
• VIM
The BioFire BCID2 Panel is indicated as an aid in the diagnosis of specific agents of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Positive results do not rule out co-infection with organisms not included in the BioFire BCID2 Panel. The BioFire BCID2 Panel is not intended to monitor treatment for bloodstream infection.
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 BioFire BCID2 Panel, and for determination of species detected but not identified within complexes, groups, or genera by the BioFire BCID2 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/K193519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193519: BioFire Blood Culture Identification 2 (BCID2) Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193519
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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