BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

K243759 · Biofire Diagnostics, LLC · PEN · Dec 20, 2024 · Microbiology

Device Facts

• Record ID: K243759
• Device Name: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
• Applicant: Biofire Diagnostics, LLC
• Product Code: PEN · Microbiology
• Decision Date: Dec 20, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3365
• Device Class: Class 2

Indications for Use

The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY Torch Systems. The BIOFIRE BCID2 Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test capable of the simultaneous detection and identification of multiple microbial nucleic acid sequences in blood culture samples from patients with signs and symptoms of bloodstream infection. The BIOFIRE BCID2 Panel is performed directly from positive blood culture samples. The BIOFIRE BCID2 Panel is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bloodstream infections. The results of the BIOFIRE BCID2 Panel are intended to be interpreted by trained healthcare professionals. The BIOFIRE BCID2 Panel is not intended to monitor the treatment of bloodstream infections.

Device Story

The BIOFIRE BCID2 Panel is a multiplexed nucleic acid test for identifying bloodstream infection pathogens and resistance markers directly from positive blood culture samples. The device uses a closed-pouch system containing all reagents in freeze-dried format. Input consists of a positive blood culture sample mixed with buffer. The system performs automated mechanical/chemical lysis, magnetic bead-based nucleic acid purification, and nested multiplex PCR. The first stage is a large-volume rt-PCR; the second stage is a single-plex nested PCR in an array. Detection is achieved via melt curve analysis using a fluorescent DNA-binding dye. A digital camera captures fluorescent images, and software automatically interprets melt curves to provide qualitative results. The device is used in clinical laboratories; operated by trained personnel. Results are interpreted alongside Gram stain findings to aid clinical decision-making regarding antimicrobial therapy. The software update adjusts melting temperature (Tm) ranges for specific assays to mitigate false-negative results caused by synthetic control material incompatibility.

Clinical Evidence

No new clinical trials were conducted. The manufacturer performed a re-analysis of existing clinical and non-clinical performance data using the modified pouch module software. This re-analysis resulted in a minor adjustment to the sensitivity for S. epidermidis (from 96.5% to 96.9%). The study conclusions and overall performance claims remain unchanged.

Technological Characteristics

Multiplexed nested nucleic acid amplification test (NAAT) with melt curve analysis. Uses BIOFIRE FILMARRAY 2.0 or TORCH systems. Reagents are freeze-dried in a single-use pouch. Automated sample preparation via mechanical/chemical lysis and magnetic bead purification. Detection via fluorescent double-stranded DNA binding dye (LC Green Plus). Software-based automated interpretation of melt curves. Room temperature storage; 12-month shelf life.

Indications for Use

Indicated for use as an aid in the diagnosis of bloodstream infection in patients with positive blood culture samples. Identifies 43 bacterial and yeast targets and select antimicrobial resistance genes (CTX-M, KPC, mecA/C, NDM, vanA/B, IMP, mcr-1, mecA/C and MREJ, OXA-48-like, VIM). Not intended to monitor treatment.

Regulatory Classification

Identification

A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.

Special Controls

In combination with the general controls of the FD&C Act, the Verigene® Gram Positive Blood Culture Nucleic Acid Test is subject to the following special controls: The special controls for the BC-GP Assay are contained in the guideline document entitled "Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures."

*Classification.* Class II (special controls). The special control for this device is FDA's guideline document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures.” For availability of the guideline document, see § 866.1(e).

Predicate Devices

• BIOFIRE Blood Culture Identification 2 (BCID2) Panel (K193519)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K243759

B Applicant

BioFire Diagnostics, LLC

C Proprietary and Established Names

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PEN | Class II | 21 CFR 866.3365 - Multiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures | MI - Microbiology |
| PAM | Class II | 21 CFR 866.3365 - Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures | MI - Microbiology |
| PEO | Class II | 21 CFR 866.3365 - Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures | MI - Microbiology |

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for an update to the BioFire BCID2 Panel pouch module software to include updates to the Tm range for some assays to mitigate issues with false negative assay results with synthetic control materials.
4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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