Search Results

The BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini) is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® SPOTFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.

The following organism types and subtypes are identified and differentiated using the SPOTFIRE R Panel Mini:

• Coronavirus SARS-CoV-2
• · Human rhinovirus
• · Influenza A virus
• · Influenza B virus
• · Respiratory syncytial virus

Nucleic acids from the viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. The detection of specific viral nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection are indicative of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, or lower respiratory tract infection that may not be detected by an NPS specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by the SPOTFIRE R Panel Mini may not be the definite cause of disease.

Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

The BIOFIRE SPOTFIRE Respiratory (R) Panel Mini simultaneously identifies five different respiratory viral pathogens in nasopharyngeal swabs (NPS) from individuals with signs and symptoms of respiratory tract infection (see Table 1). The SPOTFIRE R Panel Mini is compatible with the BIOFIRE® System, a polymerase chain reaction (PCR)-based in vitro diagnostic system for infectious disease testing. The BIOFIRE System Software executes the SPOTFIRE R Panel Mini test and interprets and reports the test results.

A test is initiated by loading Hydration into one port of the SPOTFIRE R Panel Mini pouch and NPS specimen mixed with the provided Sample Buffer into the other port of the SPOTFIRE R Panel Mini pouch and placing it in the SPOTFIRE System. The pouch contains all of the reagents required for speciment testing and analysis in a freeze-dried format; the addition of Hydration Solution and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the SPOTFIRE System Software quides the user through the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

The SPOTFIRE System contains coordinated systems of inflatable bladders and seal points, which act on the pouch to control the movement of liquid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liguid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valve to open or close a channel. In addition, electronically-controlled pneumatic pistons are multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier and cooling of the pouch to drive the PCR reactions and the melt curve analysis.

Nucleic acid extraction occurs within the SPOTFIRE R Panel Mini pouch using mechanical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the SPOTFIRE System performs a nested multiplex PCR that is executed in two stage, the SPOTFIRE System performs a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent doublestranded DNA binding dye (LC Green® Plus, BioFire Diagnostics). The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 2nd stage PCR, or nested PCR, is performed in singleplex fashion in each well of the array. At the conclusion of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.

The SPOTFIRE System Software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.

The provided text describes the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini, a PCR test for detecting respiratory viral nucleic acids. However, the document, being a Special 510(k) Summary, focuses on demonstrating substantial equivalence to a predicate device (BIOFIRE® SPOTFIRE® Respiratory (R) Panel) rather than providing detailed, de novo performance study results against specific acceptance criteria.

The key statement regarding performance data is:
"The performance data for the SPOTFIRE R Panel Mini is identical to the SPOTFIRE R Panel (K213954), but only contains data for the five analytes detected by the SPOTFIRE R Panel Mini (Coronavirus SARS-CoV-2, human rhinovirus, influenza A virus, influenza B virus, and respiratory syncytial virus). Please see the BIOFIRE Respiratory Panel Mini Instructions for Use for performance tables."

This indicates that the performance of the Mini Panel relies on the studies conducted for the full Panel. To fully answer your request, the "BIOFIRE Respiratory Panel Mini Instructions for Use" would be needed, as that is where the detailed performance tables (which would contain acceptance criteria and reported performance) are referenced.

Based on the provided text, here's what can be extracted and what cannot be:

Since the document directly states that the performance data for the Mini Panel is identical to the full Panel for the relevant analytes, and directs to the Instructions for Use for details, it implies that no new, separate, full-scale clinical study was conducted for the Mini Panel. Instead, the justification for meeting acceptance criteria is based on the performance of the predicate device.

Extracted Information from the Provided Document:

1. A table of acceptance criteria and the reported device performance:

• Cannot be fully provided from this document. The document states: "Please see the BIOFIRE Respiratory Panel Mini Instructions for Use for performance tables." This means the specific acceptance criteria and reported performance values (like sensitivity, specificity, accuracy) are not contained within this 510(k) summary directly.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Cannot be fully provided from this document. This information would be detailed in the performance study section of the predicate device's submission or its Instructions for Use, which is not included here. The document only states that the performance data for the Mini Panel is "identical" to the predicate for the five analytes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable / Cannot be provided. This device is an in vitro diagnostic (IVD) PCR test, not an imaging AI device. Ground truth for IVD tests is typically established through reference methods (e.g., highly sensitive PCR assays, culture, sequencing) on clinical samples, not by expert readers or adjudicators in the way it's done for medical imaging. The concept of "experts" as in radiologists is thus not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. As stated above, this is an IVD PCR device. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation studies where human experts disagree. For PCR tests, discordance resolution might occur by running a different highly sensitive reference method, but it's not "adjudication" in the sense used for human image interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is an in vitro diagnostic (IVD) PCR test, not an AI medical imaging device that assists human readers. There are no "human readers" interpreting images to be assisted by this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, for the predicate device. The BIOFIRE SPOTFIRE system, including this Mini Panel, functions as a standalone diagnostic test providing a qualitative result (positive/negative for each pathogen). Its performance (sensitivity, specificity, accuracy) is inherently assessed in a standalone manner, separate from human interpretation of the raw PCR data/results. The "algorithm" here is the system's software that interprets the PCR melt curve analysis and internal controls to provide a final diagnostic result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Reference molecular methods / clinical diagnosis. For IVD PCR tests, ground truth for clinical samples is typically established by comparing the device's results to a highly sensitive and specific reference molecular method (e.g., another FDA-cleared or laboratory-developed PCR assay, often employing bi-directional sequencing for confirmation) applied to the same or split clinical samples. This is implicitly what happens for the predicate device's performance studies. The overall diagnosis for a patient would then integrate this with other clinical and epidemiological information. Clinical outcomes data or pathology are not typically the primary ground truth for direct pathogen detection performance of a PCR test.

8. The sample size for the training set:

• Not explicitly stated in this document. For IVD PCR devices, the "training set" doesn't strictly apply in the sense of machine learning model training on large datasets. Instead, it refers to samples used during the development and optimization phases of the assay. This information is confidential and not typically disclosed in a 510(k) summary. The focus for this submission is on demonstrating that the modified software for the Mini Panel (which just filters results from the existing R Panel) has been "verified and validated to show no change in safety and effectiveness," implying no new large-scale training was needed.

9. How the ground truth for the training set was established:

• Not explicitly stated/applicable in the ML sense. As above, "training set" for PCR development involves using characterized samples (e.g., spiked samples, clinical samples with known positivity/negativity determined by reference methods) to optimize assay parameters. The exact methodology would be part of the intellectual property of the manufacturer and documented internally.

Summary of Acceptance Criteria and Study Proof (as much as inferred from the document):

Given the nature of this submission as a "Special 510(k)," the core proof for the device meeting acceptance criteria is its substantial equivalence to the predicate BIOFIRE® SPOTFIRE® Respiratory (R) Panel (K213954). The acceptance criteria for the Mini Panel are, by this logic, implicitly met if the performance for the shared analytes (Coronavirus SARS-CoV-2, human rhinovirus, influenza A virus, influenza B virus, and respiratory syncytial virus) is identical to the already cleared predicate device.

The study that proves the device meets the acceptance criteria is effectively the original clinical performance study conducted for the predicate BIOFIRE® SPOTFIRE® Respiratory (R) Panel (K213954).
The specific data, including sensitivity, specificity, positive predictive value, and negative predictive value, along with the sample types and sizes from those studies, would be found in the Indications for Use or similar performance summary section of the K213954 submission or its final labeling.

The current document confirms that:

• The Mini Panel is an identical product to the full Panel, with modified labeling and software to report only five of the 15 analytes.
• The modified software has been "verified and validated to show no change in safety and effectiveness."
• "The performance data for the SPOTFIRE R Panel Mini is identical to the SPOTFIRE R Panel (K213954), but only contains data for the five analytes detected by the SPOTFIRE R Panel Mini."

Therefore, the proof that the device meets acceptance criteria relies entirely on the previously conducted studies for the predicate device, which presumably demonstrated acceptable clinical performance for those five analytes.

Ask a specific question about this device