# K193519: BioFire Blood Culture Identification 2 (BCID2) Panel

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Diagnostics, LLC
- Decided: Mar 18, 2020 after 90 days
- Product code: PEN (Gram-Negative Bacteria And Associated Resistance Markers)
- Device class: 2
- Regulation: 21 CFR 866.3365
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K181493 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181493: FilmArray Blood Culture Identification (BCID) Panel, Biofire Diagnostics, LLC (2018) Summary page 5.

## Most influential descendants
- K243759: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) (2024), 0 descendants of its own

## Recalls of this device
- Jun 19, 2024 · Class II · Z-2456-2024: 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-vi
- Jan 26, 2024 · Class II · Z-1139-2024: 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: 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. 
- Feb 1, 2023 · Class II · Z-1251-2023: 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 res
- Oct 11, 2021 · Class II · Z-0312-2022: 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: 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 (
- Jan 26, 2021 · Class II · Z-1158-2021: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K193519
Methodology: https://510kreport.com/methodology