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The FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test intended for use with FilmArray systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the FilmArray RP: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Human Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other 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 is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the Film Array RP 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 FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The FilmArray Respiratory Panel is designed to be used with FilmArray systems (currently FilmArray and FilmArray 2.0). This 510(k) modifies the Device by adding the FilmArray Torch as an additional instrument system for use with the FilmArray Respiratory Panel. The FilmArray RP pouch contains freeze-dried reagents to perform nucleic acid purification. reverse transcription, and nested, multiplex PCR with DNA melt analysis. FilmArray RP simultaneously conducts 20 tests for the identification of respiratory pathogens from nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections (Table 1). Results from the FilmArray RP test are available within about one hour.

A test is initiated by loading Hydration Solution and an unprocessed patient nasopharyngeal swab (NPS) specimen (i.e. specimen mixed with Sample Buffer) into the FilmArray RP pouch. The pouch contains all of the reagents required for specimen testing and analysis in a freezedried format; the addition of Hydration Solution and specimen/Sample Buffer Mix rehydrates the reagents. After the pouch is prepared, the FilmArray software guides the user though the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

FilmArray systems contain a coordinated system 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 liquid 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 positioned over multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and the melt curve analysis.

Nucleic acid extraction occurs within the FilmArray pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the FilmArray performs a nested multiplex PCR that is executed in two stages. During the first stage, the FilmArray 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 double stranded DNA binding dye (LC Green" Plus, BioFire Defense, LLC). 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 array captures fluorescent images of the PCR reactions and software interprets the data.

The FilmArray 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 a Special 510(k) submission for the FilmArray Respiratory Panel (RP) for use with the FilmArray Torch system. This submission modifies the device by adding the FilmArray Torch as an additional instrument system for use with the already cleared FilmArray Respiratory Panel. Crucially, the reagent kit itself has not changed. Therefore, the performance characteristics demonstrated in the original clearance for the FilmArray RP on FilmArray and FilmArray 2.0 systems are largely relied upon.

The performance study described focuses on demonstrating reproducibility on the new FilmArray Torch system, rather than a full de novo clinical performance study for all targets.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this specific study, given the nature of the 510(k) (adding a new instrument to an existing assay), appears to be focused on reproducible detection at the Limit of Detection (LoD) and agreement with negative results.

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

• Test Set Sample Size: 90 replicates per analyte.
• Data Provenance: The study used contrived samples containing each FilmArray RP analyte at low positive levels (1x LoD). This implies laboratory-prepared samples, not clinical specimens. The study was conducted on three complete FilmArray Torch systems (12 FilmArray Torch Modules per system) over five days. This is a prospective laboratory study.

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

For this specific reproducibility study, the "ground truth" was inherently known because contrived samples were used. This means the researchers prepared samples with a known presence (at 1x LoD) or absence of each analyte. Therefore, no external experts were needed to establish ground truth for this particular test set.

4. Adjudication Method for the Test Set

Not applicable. Since contrived samples with known analytes (or their absence) were used, no adjudication method was required. The "ground truth" was established by the experimental design.

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

No. This document describes a reproducibility study for a new instrument platform, not a comparative effectiveness study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, this study is inherently a standalone performance evaluation of the FilmArray RP assay run on the FilmArray Torch system. The device's software automatically interprets the results. While human operators initiate the test and prepare the pouch, the detection and interpretation are performed by the automated system.

7. The Type of Ground Truth Used

For this specific reproducibility study for the FilmArray Torch instrument, the ground truth was based on known composition of contrived samples. For the original FilmArray RP assay's clinical performance, the Indications for Use (and the full 510(k) typically details this) mention:

• "Performance characteristics for Bordetella pertussis, Coronavirus OC43, Influenza A H1, Influenza A H3, Influenza A H1-2009, Influenza B, Mycoplasma pneumoniae, Parainfluenza Virus 1, Parainfluenza Virus 2, and Parainfluenza Virus 4 were established primarily with retrospective clinical specimens."
• "Performance characteristics for Chlamydophila pneumoniae were established primarily using contrived clinical specimens."
• Initial clinical studies would have likely used a combination of culture, PCR, and other reference methods as ground truth for clinical specimens.

8. The Sample Size for the Training Set

The document does not specify a separate training set for the FilmArray RP performance on the Torch system. This submission is for a new instrument, not a new algorithm from scratch. The underlying FilmArray RP assay was already cleared. The study described focuses on verifying the performance of the already-developed assay on the new instrument.

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

Not explicitly stated for a training set in this particular document. Given that the reagent kit is unchanged, the "training" for the assay itself would have occurred during the development of the original FilmArray RP, for which detailed ground truth establishment methods (likely involving reference methods, clinical correlation, etc.) would have been described in its original K143080 submission.

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