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The BioFire® COVID-19 Test 2 is a qualitative nested multiplexed RT-PCR in vitro diagnostic test intended for use with the BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems. The BioFire COVID-19 Test 2 detects nucleic acids from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs (NPS) from symptomatic individuals suspected of COVID-19 by their healthcare provider.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in NPS specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co-infection with other pathogens.

Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. The BioFire COVID-19 Test 2 is intended for use by trained medical and laboratory professionals in a laboratory setting or under the supervision of a trained laboratory professional.

For In Vitro Diagnostic Use.

The BioFire COVID-19 Test 2 is a multiplexed nucleic acid-based test for the detection of SARS-CoV-2 RNA from nasopharyngeal swabs (NPS) eluted in either transport medium or saline. The test was originally described and cleared in K211079. The BioFire COVID-19 Test 2 uses BioFire FilmArray technology and is for use with BioFire FilmArray 2.0 and BioFire FilmArray Torch instruments. Once the sample is injected into the FilmArray pouch is loaded into the Film Array instrument which performs all aspects of testing including nucleic acid extraction, reverse-transcription, and nested PCR with melt analysis. The currently cleared version of the test uses three SARS-CoV-2 assays and returns a 'SARS-CoV-2 Detected' call if one or more of the SARS-CoV-2 assays are positive.

The purpose of this submission is to display results for four additional SARS-CoV-2 assays which are currently present on the test, but for which results are masked through software. The assays are being unmasked as a mitigation against the risk of future SARS-CoV-2 variants affecting the sensitivity of the BioFire COVID-19 Test 2 due to mutations in assay primer regions. Note that to date BioFire Defense has not identified any variants that are predicted to affect the performance of the three-assay version of BioFire COVID-19 Test 2 described in K211079. These changes are being requested preemptively. The calling scheme when using the seven total SARS-CoV-2 assays will remain unchanged: one or more positive SARS-CoV-2 assay results will return an overall 'SARS-CoV-2 Detected' result.

Here's a breakdown of the acceptance criteria and the study details for the BioFire COVID-19 Test 2 based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a Special 510(k) submission where the primary change is the unmasking of four additional SARS-CoV-2 assays within an already cleared device (BioFire COVID-19 Test 2, K211079). Therefore, the "acceptance criteria" are implied by demonstrating equivalence to the predicate device's performance. The re-analysis of prior studies with the modified software is used to show this equivalence.

Since this is a submission for a software modification to unmask existing assays and not a de novo submission establishing new performance benchmarks, the acceptance criteria are largely defined by matching or showing no significant degradation from the predicate device's performance.

2. Sample Size Used for the Test Set and Data Provenance

The document states that no additional testing was performed for this submission. Instead, all study data previously submitted in K211079 were re-analyzed using the updated software.

Therefore, the "test set" for this specific submission is the re-analysis of data from the original K211079 (and potentially EUA200044) studies.

• Clinical Testing (DF-SDY-030617):
  • Sample Size: 69 positive samples, 454 negative samples. (Total = 523 samples)
  • Data Provenance: Prospective Clinical Evaluation. The document does not explicitly state the country of origin, but generally, FDA submissions for predicate devices are expected to include data from diverse geographic regions within the US, or from regions with comparable patient populations.
• Bench Testing: Sample sizes vary per study. For example:
  • LoD studies (DF-SDY-029904, DF-SDY-030331) involve serial dilutions and replicates.
  • Specificity/Exclusivity (DF-SDY-029903, DF-SDY-030333) involve testing a panel of organisms/viruses.
  • Reproducibility (DF-SDY-030398) involves testing replicates across multiple sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the clinical samples (DF-SDY-030617) would typically be established by a reference method, most commonly another FDA-authorized RT-PCR assay. The document does not specify the number or qualifications of experts involved in determining the ground truth for the clinical samples. For molecular diagnostics, "expert consensus" is less common for ground truth than established reference tests.

For bench testing studies (e.g., LoD, inclusivity, exclusivity), the ground truth is based on the known concentration of spiked analytes or the known identity of the assayed organisms/viruses, which does not typically involve human experts establishing ground truth in the same way as clinical image interpretation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set regarding human interpretation, as the device is an in vitro diagnostic (IVD) molecular test for direct detection of SARS-CoV-2 RNA. Results are determined by the instrument and its software.

For the clinical study, the reference method used to establish positive/negative status for the clinical samples would be the "adjudication." However, the method (e.g., comparison to a composite reference standard, or another cleared test) is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) device that performs a laboratory test. It does not involve human readers interpreting images or data with or without AI assistance. The output is a "SARS-CoV-2 Detected" or "SARS-CoV-2 Not Detected" result.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, the performance presented is standalone/algorithm only. The BioFire COVID-19 Test 2 is an IVD automated system. The results are generated directly by the device's software based on its internal processes (nucleic acid extraction, RT-PCR, melt analysis) without human interpretation of raw data. The study validates the device's ability to detect SARS-CoV-2 RNA independently. The phrasing "Software uses results from 7 assays" further confirms this.

7. The Type of Ground Truth Used

• Clinical Testing (DF-SDY-030617): The ground truth for the prospective clinical evaluation samples would most commonly be established by a highly sensitive and specific reference molecular assay (e.g., another FDA-cleared or EUA RT-PCR test for SARS-CoV-2), possibly combined with clinical diagnosis, but the document does not explicitly state this.
• Bench Testing:
  • LoD, Reactivity (Inclusivity): Ground truth is based on the known concentration and identity of specific SARS-CoV-2 strains/genomic material spiked into negative matrix.
  • Specificity (Exclusivity): Ground truth is based on the known identity of other respiratory pathogens or commensals tested.
  • Interfering Substances: Ground truth is based on the known presence of potential interfering substances without SARS-CoV-2.
• In Silico Analysis: Ground truth is based on publicly available genetic sequence databases (e.g., GISAID for SARS-CoV-2 variants).

8. The Sample Size for the Training Set

The document does not mention a separate training set for this submission. The purpose of this submission is to unmask existing assays on an already established device. The performance data presented are from validation and verification studies (effectively "test sets") previously conducted for the predicate device. For the original development of the BioFire COVID-19 Test 2 assays, various internal optimization and calibration steps (which could be considered analogous to "training") would have occurred, but these details are not part of this 510(k) summary.

9. How the Ground Truth for the Training Set was Established

As no specific "training set" is described for this 510(k) modification, this question is not directly applicable. For the initial development of the assays, the ground truth would have been established through a combination of:

• Bioinformatics: Designing primers and probes based on known SARS-CoV-2 sequences.
• Analytical studies: Testing synthetic targets and cultured virus at known concentrations.
• Clinical studies: Initial evaluation with patient samples where SARS-CoV-2 status was determined by a reference method.

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