The FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test intended for use with the FilmArray instrument for the simultaneous qualitative detection and identification of multiple respiratory viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using the FilmArray RP: Adenovirus, Coronavirus HKU1, Coronavirus NL63, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, Influenza B, Parainfluenza virus 3, Rhinovirus/Enterovirus, and Respiratory Syncytial Virus. The detection and identification of specific viral 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. Negative results do not preclude respiratory infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Positive results do not rule out bacterial infection or co-infection with other organisms. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory infection.

Due to seasonal prevalence, performance characteristics for Influenza A/H1, Influenza A/H3, Influenza A/2009 H1, and Influenza B were established primarily with retrospective clinical specimens.

Due to the genetic similarity between human Rhinovirus and Enterovirus, the FilmArray RP cannot reliably differentiate them. A positive FilmArray RP Rhinovirus/Enterovirus result should be followed-up using an alternate method (e.g. cell culture or sequence analysis).

The FilmArray RP detects Adenovirus species C serotype 6 with reduced sensitivity. It is recommended that specimens found to be negative for Adenovirus after examination using FilmArray RP be confirmed by an alternate method (e.g. FDA cleared molecular test or cell culture).

Performance characteristics for influenza A were established when influenza A/2009 H1N1, A/H1, and A/H3 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Device Description

The FilmArray RP System is multiplex nucleic acid test system composed of the FilmArray instrument, the FilmArray software (preinstalled on a laptop computer) and the FilmArray RP pouch. The FilmArray RP pouch contains freeze-dried reagents to perform nucleic acid purification, reverse transcription, and nested, multiplex PCR with DNA melt analysis. The Respiratory Panel (RP) pouch identifies 12 common and emerging viral respiratory pathogens (see Table 1).

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 freeze-dried format; the addition of Hydration Solution and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the FilmArrav 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.

The FilmArray instrument contains 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 reverse transcription reactions, the PCR reactions, and the melting curve analysis.

Nucleic acid extraction occurs within the FilmArray pouch using mechanical lysis and 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, Idaho Technology). This second master mix 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 second stage PCR, or nested PCR, is performed in singleplex fashion in each well of the array. At the conclusion of the 200 stage PCR, the array is interrogated by melting curve analysis for the detection of signature amplicons denoting the presence of specific viral or bacterial targets A digital camera placed in front of the second stage PCR captures fluorescent images of the PCR reactions in real time.

The FilmArray software automatically interprets the results of each DNA melting 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.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in a numerical target for metrics like sensitivity or specificity. However, it presents the reported clinical sensitivity (Positive Percent Agreement - PPA) and specificity (Negative Percent Agreement - NPA) for each detected organism from two studies: a prospective clinical study and an archived specimen study. The implicit acceptance criteria would be for these values to be high, ideally close to 100%, and for the 95% Confidence Intervals (CI) to be acceptably narrow.

Table: Reported Device Performance (Clinical Studies)

Organism/Virus	Study Type	Sensitivity (PPA)	95% CI	Specificity (NPA)	95% CI
Adenovirus	Prospective Clinical	88.9% (24/27)	70.8 - 97.7%	98.3% (812/826)	97.2 - 99.1%
Adenovirus	Archived Specimen	100.0% (27/27)	87.2 - 100%	100.0% (28/28)	87.7 - 100%
Coronavirus HKU1	Prospective Clinical	95.8% (23/24)	78.9 - 99.9%	99.8% (827/829)	99.1 - 100%
Coronavirus NL63	Prospective Clinical	95.8% (23/24)	78.9 - 99.9%	100.0% (829/829)	99.6 - 100%
Human Metapneumovirus	Prospective Clinical	94.6% (88/93)	87.9 - 98.2%	99.2% (754/760)	98.3 - 99.7%
Human Rhinovirus/Enterovirus	Prospective Clinical	92.7% (190/205)	88.2 - 95.8%	94.6% (613/648)	92.6 - 96.2%
Enterovirus	Archived Specimen	95.7% (22/23)	78.0 - 99.9%	100.0% (90/90)	96.0 - 100%
Influenza A	Prospective Clinical	90.0% (9/10)	55.5 - 99.8%	99.8% (841/843)	99.2 - 100%
Influenza A/H1	Prospective Clinical	0/0	n/a	100.0% (853/853)	99.6 - 100%
Influenza A/H1	Archived Specimen	100.0% (32/32)	89.1 - 100%	100.0% (127/127)	97.1 - 100%
Influenza A/H3	Prospective Clinical	0/0	n/a	100.0% (853/853)	99.6 - 100%
Influenza A/H3	Archived Specimen	100.0% (54/54)	93.4 - 100%	100.0% (105/105)	96.5 - 100%
Influenza A/2009 H1	Prospective Clinical	88.9% (8/9)	51.8 - 99.7%	99.6% (841/844)	99.0 - 99.9%
Influenza A/H1-2009	Archived Specimen	100.0% (34/34)	89.7 - 100%	100.0% (125/125)	97.1 - 100%
Influenza B	Prospective Clinical	0/0	n/a	100.0% (853/853)	99.6 - 100%
Influenza B	Archived Specimen	100.0% (30/30)	88.4 - 100%	100.0% (129/129)	97.2 - 100%
Parainfluenza Virus 3	Prospective Clinical	95.8% (23/24)	78.9 - 99.9%	98.8% (819/829)	97.8 - 99.4%
PIV3	Archived Specimen	100.0% (36/36)	90.3 - 100%	100.0% (93/93)	96.1 - 100%
Respiratory Syncytial Virus	Prospective Clinical	100.0% (52/52)	93.2 - 100%	89.1% (714/801)	86.8 - 91.2%

2. Sample Sizes and Data Provenance

Test Set (Clinical Performance):
- Prospective Clinical Study:
  - Sample Size: 853 subjects (from an initial enrollment of 857).
  - Data Provenance: 3 U.S. clinical sites, prospective data collected from December 2009 through May 2010.
- Archived Specimen Study:
  - Sample Size: 349 archived clinical NPS specimens were confirmed to contain or lack the analyte of interest (from 400 initially selected).
  - Data Provenance: Retrospective, preselected archived clinical NPS specimens. Age demographics provided (e.g., 89 (25.5%) ≤5 years, 188 (53.9%) unknown age from a pediatric hospital). Country of origin is implied to be U.S. from clinical sites and some strains are from particular US states, but not explicitly stated for all archived samples.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document primarily relies on comparator methods for establishing ground truth, rather than a direct count of human expert consensus.

For Adenovirus, Influenza A, Influenza B, Parainfluenza virus 3, Respiratory Syncytial Virus (Prospective Study):
- Ground Truth Method: Viral culture followed by DFA (Fluorescent Antibody) identification. "True" positives/negatives were defined based on these comparator methods.
For FluA/H1, FluA/H3, FluA/2009 H1 (Prospective Study):
- Ground Truth Method: Viral culture followed by one analytically validated PCR assay with bi-directional sequence confirmation. The comparator PCR assays were designed to amplify different sequences than the FilmArray assays. "True" positives/negatives were based on cultural positivity for Influenza A and bi-directional sequencing results matching NCBI GenBank entries.
For Human Rhinovirus, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus (Prospective Study):
- Ground Truth Method: A "predetermined algorithm that used composite comparator methods" consisting of two analytically validated PCR assays followed by bi-directional sequencing. "True" positives/negatives were based on bi-directional sequencing data matching NCBI GenBank entries or negative results from both comparator PCR assays.
For Archived Specimen Study:
- Ground Truth Method: Analyte-specific PCR and bi-directional sequencing were used to confirm the presence or absence of the analyte of interest in each specimen prior to FilmArray RP testing.

The document does not specify the number of experts or their qualifications for interpreting the DFA, viral culture, PCR, or sequencing results. It states these are "analytically validated" assays, implying expert input in their validation and interpretation, but provides no direct detail on the human experts involved in establishing the ground truth for this specific study.

4. Adjudication Method for the Test Set

The document describes comparator methods for defining "true" positive/negative results. For the clinical performance sections:

For categories like Adenovirus through RSV in the prospective study, ground truth was set by viral culture + DFA. Discrepancies between FilmArray RP and the comparator method were further investigated (e.g., footnoted retesting and bi-directional sequence analysis for false positives/negatives). For example, "Adenoviruses were identified in 13/14 false positive specimens using bi-directional sequence analysis." This implies adjudication by molecular methods (PCR and sequencing) was used to resolve discrepancies or to further confirm findings where FilmArray differed from the initial comparator method.
For Influenza A subtypes and other viruses (Rhinovirus, etc.), the ground truth was already a composite of PCR and bi-directional sequencing, suggesting internal resolution of complex cases within that ground truth establishment process.

The "archived specimen study" explicitly states that the presence or absence of the analyte was confirmed using analyte-specific PCR and bi-directional sequencing prior to FilmArray RP testing, which serves as a highly robust ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The study is a diagnostic performance evaluation comparing the device (FilmArray RP) against established laboratory methods (viral culture, PCR, sequencing) for detecting respiratory pathogens. It does not involve human readers interpreting results with or without AI assistance, or quantify the effect size of human improvement. This is a standalone diagnostic test evaluation.

6. Standalone Performance Study (Algorithm Only)

Yes, the clinical performance studies (prospective and archived specimen) describe the standalone performance of the FilmArray RP system. The device is automated with "automated test interpretation and report generation" where the "User cannot access raw data" (Table 3), indicating the algorithm's interpretation delivers the final result.

7. Type of Ground Truth Used

The ground truth used is a combination of:

Expert Consensus/Reference Methods (Viral Culture + DFA, PCR + Bi-directional Sequencing): This reflects standard laboratory diagnostic methods considered to be gold standards or highly accurate comparators at the time.
- "True" positives/negatives were determined by these reference methods.
- For discrepancies, especially for "false positives" or "false negatives" where the FilmArray RP result differed from the initial comparator, further molecular analysis (bi-directional sequence analysis) was often performed, indicating a robust process to confirm ground truth when needed.

8. Sample Size for the Training Set

The document explicitly describes studies for clinical performance evaluation and analytical validation (LoD, inclusivity, specificity, precision, interference). It does not provide details on a specific "training set" or its size, as would be typical for machine learning models. This suggests that the FilmArray RP system's interpretive algorithm (which automatically interprets melting curve analysis results) was developed and validated internally using methods not detailed in this summary (e.g., extensive analytical testing, algorithm tuning, and potentially internal datasets before these formal clinical studies). The "analytical studies" sections (LoD, inclusivity, etc.) would contribute to refining and confirming the algorithm's performance.

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

Since a "training set" is not explicitly defined or detailed in this summary, the method for establishing its ground truth is also not provided. However, based on the analytical studies described:

LoD (Limit of Detection): Established by testing limiting dilutions of live, quantified viruses (or clinical specimens in one case) where the presence and concentration are precisely known.
Analytical Reactivity (Inclusivity): Evaluated using known strains/isolates, often quantified. Bi-directional sequencing and bioinformatics (in silico analyses) were used to confirm specific viral identities and predict reactivity.
Analytical Specificity (Cross-reactivity and Exclusivity): Tested against high concentrations of known interfering organisms or substances.

These analytical studies established ground truth for known viral identities and concentrations under controlled conditions, which would underpin the fundamental ability of the algorithm to accurately detect and identify targets. While not a "training set" in the modern ML sense, these analytical validations serve a similar purpose in confirming the algorithm's foundational accuracy against known truths.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be 'K103175'. The handwriting is somewhat stylized, with distinct shapes for each number and letter. The image is in black and white, with the characters appearing dark against a lighter background.

11 510(k) Summary

FFB 17 2011

510(k) Summary Idaho Technology Inc. FilmArray RP Test System

Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitted by:

Idaho Technology Inc 390 Wakara Way Salt Lake City, UT 84108

Telephone: 801-736-6354 Facsimile: 801-588-0507

Contact: Beth Lingenfelter, ext. 407

Date Submitted: February 2, 2011

Device Name and Classification:

Trade Name: FilmArray RP System

Regulation Number: 21 CFR 866.3980

Classification Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay

Predicate Device:

K063765, K081483, K091677 - Luminex® xTAG™ Respiratory Viral Panel (RVP).

Intended Use:

Idaho Technology Inc. 510(k) FilmArray Respiratory Panel System

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symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. Negative results do not preclude respiratory infection and should not be used as the sole basis for diagnosis. treatment or other management decisions. Positive results do not rule out bacterial infection or co-infection with other organisms. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into considertation in order to obtain the final diagnosis of respiratory infection.

Due to seasonal prevalence, performance characteristics for Influenza A/H1, Influenza A/H3, Influenza A/2009 H1, and Influenza B were established primarily with retrospective clinical specimens.

Device Description:

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Table 1. Viruses Detected by the FilmArray Respiratory Panel

Viral Respiratory Pathogens
Influenza A
H1 subtype
H3 subtype
2009 H1 subtype
Influenza B
Adenovirus
Coronavirus HKU1
Coronavirus NL63
Human Metapneumovirus
Parainfluenza Virus 3
Respiratory Syncytial Virus
Rhinovirus and Enterovirus

Idaho Technology Inc. 510(k) FilmArray Respiratory Panel System

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Substantial Equivalence:

The Luminex® xTAG™ RVP is a PCR-based system for detecting the presence of viral nucleic acid in nasopharyngeal swabs collected from individuals with signs and symptoms of respiratory illness. The similarities and differences between the xTAG RVP and the FilmArray RP are outlined below.

Element	FilmArray Respiratory Panel TestSystem	Luminex® xTAG™ RVP
OrganismsDetected	Influenza A, Influenza A subtype H1,Influenza A subtype H3, Influenza B,Respiratory Syncytial Virus, humanMetapneumovirus, Adenovirus,Parainfluenza 3, andRhinovirus/Enterovirus	SameSee below for differences
Analyte	RNA/DNA	Same
TechnologicalPrinciples	multiplex nucleic acid	SameSee below for differences
SpecimenTypes	Nasopharyngeal swabs	Same

Table 2. Similarities between the xTAG RVP and the FilmArray RP

Table 3. Differences between the xTAG RVP and the FilmArray RP

Element	FilmArray Respiratory Panel TestSystem	Luminex® xTAG™ RVP
OrganismsDetected	Can distinguish Influenza A subtype 2009H1 from Influenza A subtype H1.Also detects Coronavirus NL63 andCoronavirus HKU1.	Can distinguish Respiratory Syncytial VirusType A from Respiratory Syncytial VirusType B. Detects Parainfluenza virus 1 andParainfluenza virus 2.
TechnologicalPrinciples	Nested multiplex RT-PCR followed by highresolution melting analysis to confirmidentity of amplified product.	Multiplex RT-PCR and multiplex TSPEfollowed by Fluorescence-activated sortingof labeled beads coupled to streptavidin-conjugated biotinylated products
Instrumentation	FilmArray Instrument	PCR ThermocyclerLuminex® 100 IS or 200 system
Time to result	Less than 1 hour	Approximately 8 hours
TestInterpretation	Automated test interpretation and reportgeneration. User cannot access raw data.	Semi-automated test interpretation. Usermust review all "no call" results todetermine cause and retesting strategy.
SamplePreparationMethod	Sample Processing is automated in theFilmArray instrument.	Up front sample processing is required toextract nucleic acid.

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Element	FilmArray Respiratory Panel TestSystem	Luminex® xTAG™ RVP
ReagentStorage	Reagents are stored at room temperature.	Reagents stored at 4°C and -20°C.
Controls	Two controls are included in each reagentpouch to control for sample processing andboth stages of PCR and melt analysis.	Internal control added to each sample.External control processed with each batchof samples.
UserComplexity	Moderate/Low	High

Summary of Performance Data

Clinical Performance

The clinical performance of the FilmArray RP system was established during a prospective study at 3 U.S. clinical sites over a 6 month time period (December 2009 through May 2010). Subjects with signs and/or symptoms of respiratory infection were invited to participate. Upon obtaining informed consent, NPS samples were collected for FilmArray and comparator testing; a second respiratory sample was collected from each subject for viral culture reference testing. A total of 857 subjects were initially enrolled in the study and four were withdrawn. Table 4, provides a summary of demographic information for the 853 subjects that participated in the prospective study.

Sex	Number of Subjects
Male	449 (53%)
Female	404 (47%)
Age
≤5	484 (57%)
6-21	95 (11%)
22-49	190 (22%)
≥50	84 (10%)

Table 4. Demographic Summary for FilmArray RP Prospective Study

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Each NPS specimen was tested with the FilmArray RP. The performance of the FilmArray RP was evaluated by comparing the FilmArray RP test result for each member of the panel with the appropriate comparator/reference methods shown in Table 5.

Organism/Virus	Reference/Comparator Method(s)
Adenovirus
Influenza A	Viral culture followed by DFAidentification1
Influenza B
Parainfluenza virus 3
Respiratory Syncytial Virus
FluA/H1 subtyping	1 PCR test of influenza A positive viral
FluA/H3 subtyping	culture with bi-directional sequence
FluA/2009 H1subtyping	confirmation2
Human Rhinovirus
Enterovirus	2 PCR tests of patient specimen with bi-
Coronavirus NL63	directional sequence confirmation3
Coronavirus HKU1
Human Metapneumovirus

Table 5. Reference/Comparator Methods Used to Assess FilmArray RP Performance

1 Performance of the FilmArray RP system detecting Adenovirus, Flu A. Flu B. PIV3, or RSV. respectively, was compared to viral culture followed by fluorescent antibody identification. "True" Adenovirus, Influenza B, Parainfluenza virus 3, or RSV positively, were considered as any sample that tested positive for Adenovirus, Influenza A, Influenza B, Parainfluenza virus 3, or RSV, respectively, by viral culture followed by DFA testing. "True" Adenovirus, Influenza A. Influenza virus 3, or RSV negatives, respectively, were considered as any sample that tested negative for Adenovirus. Influenza B. Parainfluenza virus 3, or RSV. respectively, by viral culture followed by DFA testing.

2 Performance of the FilmArray RP system detecting Influenza A/H1, A/H3, or A/2009 H1, respectively, was compared to viral culture followed by one analytically validated PCR assay with bi-directional sequence confirmation. The comparator assays were designed to amplify a different sequence from that amplified by the FilmArray assay(s). None of the comparator PCR assays overlapped any FilmArray amplicon sequence even if the same gene was targeted. "True" Influenza A/H1, A/H3, or A/2009 H1 positively, were considered as any sample that tested positive for Influenza A by viral culture, and had bi-directional sequencing pre-defined quality acceptance criteria that matched Influenza A/H1, A/H3, or A/2009 H1 sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.ncbi.nlm.nih.gov), respectively, with acceptable E-values. "True" Influenza A/H1, A/H3, or A/2009 H1 negatively, were considered as any sample that tested negative for Influenza A by viral culture, or any sample that tested positive for Influenza A virus by viral culture, but tested negative by the respective Influenza A subtype specific PCR assay.

3 Performance of the FilmArray RP system detecting Human Rhinovirus, Coronavirus NL63, Coronavirus HKU1. or Human Metapneumovirus, respectively, was compared to a predetermined algorithm that used composite comparator methods. The methods consist of two analytically validated PCR assays followed by bi-directional sequencing. The comparator assays were designed to amplify a different sequence from that amplified by the FilmArray assay(s). None of the comparator PCR assays overlapped any FilmArray amplicon sequence even if the same gene was targeted. "True" Human Rhinovirus, Enterovirus NL63, Coronavirus HKU1, or Human Metapneumovirus positives, respectively, were considered as any sample that had bi-directional sequencing data meeting pre-defined quality acceptance criteria that matched Human Rhinovirus, Coronavirus NL63, Coronavirus HKUI, or Human Metapneumovirus sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.ncbi.nlm,nih.gov), respectively, with acceptable E-values. "True" Human Rhinovirus, Enterovirus, Coronavirus NL63, Coronavirus HKU1, or Human Metapneumovirus negatives, respectively, were considered as any sample that tested negative by both of the comparator PCR assays.

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A total of 853 specimens were evaluated in this study. Clinical sensitivity or positive percent agreement (PPA) was calculated as 100% x (TP / TP + FN). True positive (TP) indicates that both the FilmArray RP and comparator method had a positive result for this specific analyte and false negative (FN) indicates that the FilmArray result was negative while the comparator result was positive. Specificity was calculated as 100% x (TN / TN + FP). True negative (TN) indicates that both the FilmArray RP and the comparator method had negative results and a false positive (FP) indicates that the FilmArray RP result was positive but the comparator results was negative. The exact binomial two-sided 95% confidence interval was calculated. The results are summarized in Table 6.

	Sensitivity	95% CI	Specificity	95% CI
Adenovirus	24/27a	88.9%	70.8 - 97.7%	812/826b	98.3%	97.2 - 99.1%
Influenza A	9/10	90.0%	55.5 - 99.8%	841/843d	99.8%	99.2 - 100%
Influenza A/H1	0/0	n/a	n/a	853/853	100%	99.6 - 100%
Influenza A/H3	0/0	n/a	n/a	853/853	100%	99.6 - 100%
Influenza A/2009 H1	8/9	88.9%	51.8 - 99.7%	841/844d	99.6%	99.0 - 99.9%
Influenza B	0/0	n/a	n/a	853/853	100%	99.6 - 100%
Parainfluenza Virus 3	23/24e	95.8%	78.9 - 99.9%	819/829f	98.8%	97.8 - 99.4%
Respiratory Syncytial Virus	52/52	100%	93.2 - 100%	714/801g	89.1%	86.8 - 91.2%
	PPA	95% CI	NPA	95% CI
Coronavirus HKU1	23/24	95.8%	78.9 - 99.9%	827/829c	99.8%	99.1 - 100%
Coronavirus NL63	23/24	95.8%	78.9 - 99.9%	829/829	100%	99.6 - 100%
Human Metapneumovirus	88/93	94.6%	87.9 - 98.2%	754/760	99.2%	98.3 - 99.7%
Human Rhinovirus/Enterovirus	190/205	92.7%	88.2 - 95.8%	613/648	94.6%	92.6 - 96.2%

Table 6, Clinical Sensitivity and Specificity for the Film Array RP Prospective Clinical Study

4 The FilmArty RP system detected Adenovirus in 1/3 false negative specimens when retested. The Adenovirus in the retested specimen was identified as species C by bi-directional sequence analysis. The remaining two false negative specimens were identified as species C and species B.

8 Adenoviruses were identified in 13/14 false positive specimens using bi-directional sequence analysis. Ten were identified as species C, two as species B, and one as species E.

CoV-HKUI viruses were identified in 2/2 false positive specimens using bi-directional sequence analysis with an alternate assav.

4 Influenza A viruses (2009 H1 subtype) were identified in 3/3 false positive specimens (2/2 false positive compared to influenza A culture alone) using sequence analysis with an alternate assay.

& The FilmArray RP system detected PIV3 in the single false negative specimen when retested.

1 PIV3 viruses were identified in 10/10 false positive specimens using bi-directional sequence analysis.

8 RSV viruses were identified in 83/87 false positive specimens using bi-directional sequence analysis.

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The FilmArray RP system detected a total of 81 mixed infections in the prospective clinical evaluation. This represents 16.1% of the total positive specimens (81/502). Seventy-six (76/81; 93.8%) were double infections, and 5 (5/81; 6.2%) were triple infections. The total number of test results comprising these co-infections was 167. The single most common co-infection (21/81; 25.9%) was Human Rhinovirus/Enterovirus with Respiratory Syncytial Virus. These viruses were the most prevalent in the tested population. Out of the 81 co-infections, 47 contained one or more analytes that had not been detected with the reference/comparator methods, i.e. discrepant co-infection.

Organism Combinations	NumberofPositiveSamples	Percentageof TotalSamplesTested	Organism	Number ofMixedInfections	Prevalencein MixedInfections
HRV/Entero + RSV	21	2.46%	Adenovirus	16	19.75%
Adenovirus + HRV/Entero	9	1.06%	CoVHKU1	10	12.35%
HRV/Entero + PIV3	8	0.94%	CoVNL63	13	16.05%
hMPV + HRV/Entero	7	0.82%	hMPV	22	27.16%
hMPV + RSV	4	0.47%	HRV/Entero	56	69.14%
CoVNL63 + HRV/entero	4	0.47%	FluA/H1	0	0.00%
CoVHKU1 + hMPV	3	0.35%	FluA/H1-2009	0	0.00%
CoVHKU1 + HRV/Entero	3	0.35%	FluA/H3	0	0.00%
CoVHKU1 + RSV	3	0.35%	FluB	0	0.00%
CoVNL63 + hMPV	3	0.35%	PIV3	14	17.28%
CoVNL63 + RSV	3	0.35%	RSV	36	44.44%
hMPV + PIV3	3	0.35%
Adenovirus + HRV/Entero +PIV3	2	0.23%
Adenovirus + RSV	2	0.23%
Adenovirus + CoVNL63	1	0.12%
Adenovirus + hMPV	1	0.12%
Adenovirus + PIV3	1	0.12%
CoVNL63 + HRV/Entero + RSV	1	0.12%
CoVHKU1 + HRV/Entero +RSV	1	0.12%
CoVNL63 + hMPV + RSV	1	0.12%
Total Mixed Infections	81	9.50%

Table 7. Mixed Infections Detected by FilmArray RP and Prevalence of Individual Analytes in Mixed Infections

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Table 8 provides the prevalence and age distribution of FilmArray RP detected analytes in the clinical study. The most prevalent analytes were Human Rhinovirus/Enterovirus, Respiratory Syncytial Virus, and Human Metapneumovirus; these three analytes comprised 78% of all positive results. Positive results were obtained across all age groups tested; however, the majority was detected in children 5 years or younger.

Analyte	Total(Prevalence)	≤ 5 years	6-21years	22-49years	≥ 50years
Adenovirus	38 (4.5%)	32	2	3	1
Coronavirus HKU1	25 (2.9%)	12	1	8	4
Coronavirus NL63	23 (2.7%)	17	2	2	2
Human Metapneumovirus	94 (11%)	76	4	10	4
Human Rhinovirus/Enterovirus	225 (26.4%)	161	24	29	11
Influenza A (all subtypes)	11 (1.3%)	1	1	7	2
Influenza A/H1	0 (0%)	0	0	0	0
Influenza A/2009 H1	11 (1.3%)	1	1	7	2
Influenza A/H3	0 (0%)	0	0	0	0
Influenza B	0 (0%)	0	0	0	0
Parainfluenza Virus 3	33 (3.9%)	31	1	0	1
Respiratory Syncytial Virus	139 (16.3%)	127	3	4	5

Table 8. Prevalence and Age Distribution of Analytes in the Clinical Study

Several analytes, such as influenza viruses were either not encountered in the clinical study or had a low prevalence. To supplement the results of the prospective clinical study, an evaluation of preselected archived samples was performed.

Testing of Preselected Archived Specimens

In addition to the prospective clinical study, archived clinical NPS specimens were also tested using the FilmArray RP. The specimens were selected because they had previously tested positive for one of the following organisms: Adenovirus, Enterovirus, Influenzas A/H1, 2009 H1N1, and H3, Influenza B, and Parainfluenza Virus 3, or had been negative by previous testing methods. Prior to testing with the FilmArray RP, the presence or absence of the analyte of interest was confirmed in each specimen using analyte specific PCR and bi-directional sequencing. Of 400 specimens, 349 were confirmed to contain the analyte of interest (or lack thereof for negative specimens). The specimens were organized into "test panels" and randomized such that the users testing the samples with the FilmArray RP were blinded as to the expected test result. Each panel contained specimens known to be positive and negative for the specific analyte being evaluated allowing the calculation of a positive percent agreement (PPA) and a negative percent agreement (NPA). A summary of the available demographic information of the tested samples is provided in Table 9 and the results of the FilmArray testing are presented in Table 10.

{9}------------------------------------------------

Total Specimens		349
Sex	Female (%)	82 (23.5%)
	Male (%)	79 (22.6%)
	Unknown	188(53.9%)
Age	Avg	14.1
	Median	4.0
	Min	0.5
	Max	83.0
Age Range	≤5	89 (25.5%)
	6-21	35 (10.0%)
	22-49	23 (6.6%)
	≥50	14 (4.0%)
	Unknowna	188(53.9%)

Table 9. Demographic Summary of FilmArray RP Archived Specimen Study

4 Demographic information was not provided for specimens from one source. Because the specimens were provided by a pediatric hospital, it is understood that the age range of specimens was from <1 yrs to 21 yrs.

		Table 10. FilmArray Archived Specimen Performance Data Summary
--	--	----------------------------------------------------------------	--

	Positive Percent Agreement (PPA)			Negative Percent Agreement (NPA)
	TP/TP+FN	Percent	95% CI	TN/TN+FP	Percent	95% CI
Adenovirus	27/27	100.0%	87.2 - 100%	28/28	100.0%	87.7 - 100%
Enterovirus	22/23	95.7%	78.0 - 99.9%	90/90	100.0%	96.0 - 100%
FluA/H1	32/32	100.0%	89.1 - 100%	127/127	100.0%	97.1 - 100%
FluA/H1-2009	34/34	100.0%	89.7 - 100%	125/125	100.0%	97.1 - 100%
FluA/H3	54/54	100.0%	93.4 - 100%	105/105	100.0%	96.5 - 100%
Influenza B	30/30	100.0%	88.4 - 100%	129/129	100.0%	97.2 - 100%
PIV3	36/36	100.0%	90.3 - 100%	93/93	100.0%	96.1 - 100%

{10}------------------------------------------------

Selected Analytic Studies

Limit of Detection

The analytical sensitivity or Limit of Detection (LoD) for each FilmArray RP analyte (except for Coronavirus HKU1) was determined by testing limiting dilutions of live, quantified viruses. The LoD for Coronavirus HKU1 was determined by testing limiting dilutions of a clinical specimen containing a high viral load of Coronavirus HKU1. LoD is defined as the lowest concentration at which the analyte is consistently detected (detection in ≥95% of samples tested). Simulated NPS sample matrix (cultured human cells in VTM) was spiked with one or more analytes and at least 20 replicates were tested at the LoD concentration. The LoD for each FilmArray RP analyte is listed in Table 11.

Organism	Strain Identification	Limit of Detection
Adenovirus	Serotype 1 (Species C)	300 TCID50/mL
Coronavirus HKU1a	Clinical Specimen (Type B )	1.9 x 106 RNA copies/mL
Coronavirus NL63	NR-470	5 TCID50/mL
Human Metapneumovirus	Type A1 (hMPV-16, IA10-2003)	2 TCID50/mL
Enterovirus	Echovirus 6	30,000 TCID50/mL
Human Rhinovirus	A1	1 TCID50/mL
Influenza A/H1	A/Brisbane/59/07	200 TCID50/mL
Influenza A/H1	A/New Caledonia/20/99	2,000 TCID50/mL
Influenza A/2009 H1	A/SwineNY/03/2009	100 TCID50/mL
Influenza A/H3	A/Wisconsin/67/2005	5 TCID50/mL
Influenza A/H3	A/Port Chalmers/1/73	50 TCID50/mL
Influenza B	B/FL/04/06	60 TCID50/mL
Influenza B	B/Taiwan/2/62	60 TCID50/mL
Parainfluenza Virus 3	Type 3	10 TCID50/mL
Respiratory Syncytial Virus	Type A	2 TCID50/mL

Table 11. LoD for Analytes Detected by FilmArray RP

" Coronavirus HKU1 was quantified by a non-FilmArray real-time PCR assay against a standard curve of synthetic Coronavirus HKUI RNA transcript to obtain quantification of the viral nucleic acid in the clinical specimen (RNA copies/mL).

NOTE: Most analytes were re-grown and quantified in TCID-s(50% Tissue Culture Infectious Dose). The unit TCID-so is a measure of infectivity or cytotoxicity rather than number of organisms or copies of nucleic acid. Variability in TCIDs/mL may not accurately reflect differences in the relative of detection between different organisms or different strains of the same organism.

{11}------------------------------------------------

Analytical Reactivity (Inclusivity)

The analytical reactivity of the FilmArray RP system assays was evaluated with an inclusivity panel consisting of 99 strains or isolates that represent the genetic, temporal. and geographic diversity of the FilmArray RP analytes. The tested organisms include: 17 Adenovirus, 4 Coronavirus (3 HKU1 and 1 NL63), 10 human Metapneumovirus, 12 Enterovirus, 14 Rhinovirus, 22 Influenza A (including 10 Influenza A/H1, 3 Influenza A/2009 H1 and 9 Influenza A/H3), 11 Influenza B, 3 Parainfluenza virus 3 and 6 Respiratory Syncytial Virus. Each organism was initially tested in a simulated NPS sample matrix at or near the system LoD. Higher concentrations were tested if the analyte was not detected at LoD.

Each of the 99 strains tested in this study were reactive with the FilmArray RP system. Reactivity of the FilmArray RP system with Adenovirus C serotype 6 was 10.000-fold less than the system LoD due to sequence variation in the region targeted by the FilmArray RP Adenovirus assay.

Additional clinical data analyses, and in silico analyses were also carried out to supplement the testing of the inclusivity panel.

Results from inclusivity testing are presented below. The concentration and multiple of LoD at which each strain was detected by the FilmArray RP system is indicated.

Species	Serotype (Isolate)	Concentration	Multiple of LoD
A	31	300 TCID50/mL	1x
	3	300 TCID50/mL	1x
	7a	300 TCID50/mL	1x
	7d2 (Iowa/2001)	300 TCID50/mL	1x
B	7h (Iowa/1999)	300 TCID50/mL	1x
	11 (Wisconsin/2005)	3,000 TCID50/mL	10x
	14 (Missouri/2005)	300 TCID50/mL	1x
	21 (Missouri/2005)	300 TCID50/mL	1x
	34 (Texas/2005)	300 TCID50/mL	1x
C	1	300 TCID50/mL	1x
	2 (New York/2004)	30,000 TCID50/mL	100x
	5	3,000 TCID50/mL	10x
	6 (Colorado/2005)*	3,000,000 TCID50/mL	10,000x
D	8	3,000 TCID50/mL	10x
E	4a (S Carolina/2004)	300 TCID50/mL	1x
	4p3 (New Jersey/2005)	300 TCID50/mL	1x

Table 12. Results of Inclusivity Testing for Adenovirus

{12}------------------------------------------------

Species	Serotype (Isolate)	Concentration	Multiple of LoD
F	41 (Indiana/2004)	300 TCID50/mL	1x

*Due to sequence variation, the FilmArray RP Adenovirus assay reacts with adenovirus serotype 6 (species C) less efficiently than with other adenovirus serotypes.

Supplemental Adenovirus Reactivity Information (Clinical Data and in silico analyses):

A subset of prospective and retrospective archived clinical specimens that were FilmArray positive for Adenovirus was subjected to PCR and bi-directional sequence analysis. BLAST analysis of the sequence data obtained for a region of the Adenovirus polymerase gene identified adenovirus species B (serotypes 3, 3+11p, 7, 16 and 21), species C (serotypes 1, 2, and 5), and species E (serotype 4) in these clinical specimens. Species B, C and E are the most common Adenovirus species associated with respiratory illness. Species A, D, and F (often associated with conjunctivitis and gastroenteritis) were not identified in clinical specimens.

In addition to laboratory testing, bioinformatics resources were also used to predict reactivity of additional Adenovirus species and serotypes with the FilmArray RP System. Simulated reactivity was based on the number and location of mismatches between the target sequence and the assay primer(s). Table 13 lists the adenovirus types that were not tested by the FilmArray system either in analytical testing. Based on the bioinformatics analysis, the FilmArray RP system is predicted to react with all of the indicated Adenovirus species and serotypes.

Virus	Species	Serotype	GenBank ID	Simulated FilmArrayAdenovirus Result
HumanAdenovirus	A	12	AB330093	Positive
	A	18	DQ149610	Positive
		16	AB330097	Positive
	B	35	AB052912	Positive
	B	50	DQ149643	Positive
	D	9	AB330090	Positive
	D	10	DQ149615	Positive
	D	13	DQ149616	Positive
	D	15	DQ149617	Positive
	D	17	AB330098	Positive
	D	19	DQ149618	Positive
	D	20	DQ149619	Positive
	D	22	DQ149620	Positive
	D	23	DQ149621	Positive
	D	24	DQ149622	Positive

Table 13. Simulated FilmArray RP Reactivity with Untested Adenovirus Serotypes

{13}------------------------------------------------

Species	Serotype	GenBank ID	Simulated FilmArrayAdenovirus Result
	25	DQ149623	Positive
	26	DQ149624	Positive
	27	DQ149625	Positive
	28	DQ149626	Positive
	29	DQ149627	Positive
	30	DQ149628	Positive
	32	DQ149629	Positive
	33	DQ149630	Positive
	36	DQ149631	Positive
	37	DQ149632	Positive
	38	DQ149633	Positive
	39	DQ149634	Positive
	42	DQ149635	Positive
	43	DQ149636	Positive
	44	DQ149637	Positive
	45	DQ149638	Positive
	46	DQ149639	Positive
	47	DQ149640	Positive
	48	AB330129	Positive
	49	DQ149641	Positive
	51	DQ149642	Positive
	53	FJ169625	Positive
F	40	AB330121	Positive
G	52	DQ923122	Positive

Table 13. Simulated FilmArray RP Reactivity with Untested Adenovirus Serotypes

Table 14. Results of Inclusivity Testing for Coronaviruses

Type	Strain / Isolate	Concentration ab	Multiple of LoD
	Clinical Sample #1120	$2.08 x 10^6$RNA copies/mL	1.1x
HKU1	Clinical Sample # 6123	$1.41 x 10^4$ TCID50/mL~ $1.9 x 10^6$RNA copies/mL	1x
	Clinical Sample #6213 (Type B)c	$1.9 x 10^6$RNA copies/mL	1x
NL63	BEI Resources NR-470	50 TCID50/mL	1x

4 Virus contained in Clinical Sample #6123 was grown in culture and quantified (TCIDs) by infectivity assay. b Quantification of the viral RNA contained in clinical specimens containing Coronavirus HKU1 was performed using real-time RT-PCR against a standard curve generated from a synthetic RNA template.

6 Phylogenetic information for Coronavirus HKU1 Clinical Sample #6213 was obtained from bi-directional sequence analysis of the nucleocapsid (N) gene.

{14}------------------------------------------------

Subtype		Strain ID	Concentration	Multiple of LoD
A1	9	IA3-2002	2 TCID50/mL	1x
	16	IA10-2003	2 TCID50/mL	1x
A2	20	IA14-2003	2 TCID50/mL	1x
	27	IA27-2004	2 TCID50/mL	1x
B1	3	Peru2-2002	2 TCID50/mL	1x
	5	Peru3-2003	2 TCID50/mL	1x
	13	IA7-2003	2 TCID50/mL	1x
	18	IA18-2003	2 TCID50/mL	1x
B2	8	Peru6-2003	2 TCID50/mL	1x
	22	IA16-2003	2 TCID50/mL	1x

Table 15. Results of Inclusivity Testing for Human Metapneumovirus

Table 16. Results of Inclusivity Testing for Enterovirus and Rhinovirus

Species	Strain	Concentrationa	Multiple of LoD
Enterovirus A	Coxsackievirus A10 ATCC VR-168	30,000 TCID50/mL	1x
	Enterovirus 71 ATCC VR-1432	1:30,000dilution of stock	n/a
	Enterovirus 71	9400 TCID50/mLb	<1x
Enterovirus B	Coxsackievirus A9	9400 TCID50/mLb	<1x
	Coxsackievirus B3	30,000 TCID50/mL	1x
	Coxsackievirus B4	30,000 TCID50/mL	1x
	Echovirus 6	30,000 TCID50/mL	1x
	Echovirus 9	9400 TCID50/mLb	<1x
	Echovirus 11	300,000 TCID50/mL	10x
Enterovirus C	Coxsackievirus A21 /KuykendallATCC VR-850	30,000 TCID50/mL	1x
	Coxsackievirus A24 DN-19ATCC VR-583	30,000 TCID50/mL	1x
Enterovirus D	Enterovirus 68 (F02-3607 corn)ATCC VR-1197	30,000 TCID50/mL	1x
Rhinovirus A	A1	1 TCID50/mL	1x
	A2 (HGP) ATCC VR-482	10 TCID50/mL	10x
	A7 (68-CV11) ATCC VR-1601	1 TCID50/mL	1x
	A16 (11757) ATCC VR-283	10 TCID50/mL	10x
	A34 (137-3) ATCC VR-507	1 TCID50/mL	1x
	A57 (Ch47) ATCC VR-1600	100 TCID50/mL	100x

{15}------------------------------------------------

Species	Strain	Concentrationa	Multiple of LoD
	A77 (130-63) ATCC VR-1187	1 TCID50/mL	1x
	A85 (50-525-CV54) ATCC VR-1195	10 TCID50/mL	10x
	B3 (FEB) ATCC VR-483	1 TCID50/mL	1x
	B14 (1059) ATCC VR-284	1 TCID50/mL	1x
Rhinovirus B	B17 (33342) ATCC-282	100 TCID50/mL	100x
	B27 (5870) ATCC VR-1137	1 TCID50/mL	1x
	B42 (56822) ATCC VR-338	10 TCID50/mL	10x
	B83 (Baylor 7) ATCC VR-1193	1 TCID50/mL	1x

ª The LoD for Enterovirus is 30,000 TCID50mL. The LoD for Rhinovirus is 1 TCID50mL.

b Strains were tested below the LoD concentration due to a lesser concentration of virus in the culture fluid.

Supplemental Human Rhinovirus/Enterovirus Reactivity Information

(clinical data and in silico analyses):

In addition to the analytical inclusivity testing, BLAST analysis was performed on sequence data (5' UTR) obtained from prospective and retrospective archived clinical specimens that were FilmArray positive for Human Rhinovirus/Enterovirus. The following species and subtypes were identified in clinical specimens:

Enterovirus Species A:	Enterovirus serotype 71Coxsackievirus A2 and A6
Enterovirus Species B:	Echovirus serotypes 3, 6, 7, 11, 15, 21 and 30Coxsackievirus B1, B3 and A9Enterovirus serotypes 81 and 88
Rhinovirus Species A:	Human Rhinovirus serotypes 1B, 8, 9,10, 13, 19, 21, 22, 23,28, 30, 32, 34, 38, 39, 40, 46, 47, 49, 51, 54, 56, 58, 59, 61, 62,66, 68, 75, 77, 78, 80, 82, 98 and 100
Rhinovirus Species B:	Human Rhinovirus serotypes 27, 69, 83 and 91
Rhinovirus Species C:	at least 3 individual strains and 12 distinct isolates

ªHuman Rhinovirus species C (also known as Enterovirus species D) has not been classified into serotypes.

{16}------------------------------------------------

Enterovirus species C includes Poliovirus types 1-3 (PV1, PV2, and PV3). Simulated reactivity of the FilmArray RP Human Rhinovirus/Enterovirus assays with Enterovirus Species C Poliovirus sequences was generated using a bioinformatics approach. Alignment of assay primer sequences with the GenBank sequences indicates the FilmArray RP assay will react with Poliovirus types 1, 2 and 3, giving a Human Rhinovirus/Enterovirus result.

Strain	GenBank ID	Simulated FilmArray RP Result
Human poliovirus 1 strainCHN8264c/GZ/CHN/2004	FJ769385	Human Rhinovirus/Enterovirus
Human poliovirus 2, complete genome	AY177685	Human Rhinovirus/Enterovirus
Human poliovirus 3 strain IRA10853, completegenome	EU684056	Human Rhinovirus/Enterovirus

Table 17. Simulated Reactivity of the FilmArray RP HRV and Entero Assays with Poliovirus Sequences

Type	Strain	Concentration	Multiple of LoD
Influenza A(H1N1)	A/Brisbane/59/07	200 TCID50/mL	1x
	A/Solomon Islands/3/2006	200 TCID50/mL	1x
	A/Hawaii/15/01CDC#2001701117	1:300 ª	n/a
	A/New Caledonia/20/99	200 TCID50/mL	1x
	A1/Denver/1/57	200 TCID50/mL	1x
	A/Mal/302/54	200 TCID50/mL	1x
	A1/FM/1/47	200 TCID50/mL	1x
	A/Weiss/43	200 TCID50/mL	1x
	A/PR/8/34	2000 TCID50/mL	10x
	A/NWS/33	200 TCID50/mL	1x
	Swine NY/01/2009	100 TCID50/mL	1x
Influenza A(H1N1-2009)	Swine NY/02/2009	100 TCID50/mL	1x
	Swine NY/03/2009	100 TCID50/mL	1x
	Swine NY/03/2009	100 TCID50/mL	1x
Influenza A(H3N2)	A/Brisbane/10/07	5 TCID50/mL	1x
	A/Wisconsin/67/2005	5 TCID50/mL	1x
	A/NewYork/55/2005CDC#2005705561	1:300,000 ª	n/a
	A/Victoria/3/75	5 TCID50/mL	1x

Table 18. Results of Inclusivity Testing for Influenza A

{17}------------------------------------------------

Strain	Concentration	Multiple of LoD
A/Port Chalmers/1/73	5 TCID50/mL	1x
A/Aichi/2/68	50 TCID50/mL	10x
A/Hong Kong/8/68	5 TCID50/mL	1x
Alice (vaccine) A/England/42/72ATCC VR-776	5 TCID50/mL	1x
MRC-2 Recombinant strainATCC VR-777	5 TCID50/mL	1x

4 Strain was not re-cultured and titered. Dilutions of the original culture/titer from the CDC were used. The HA titer for A/Hawaii/15/01 is unknown and the HA titer for A/NewYork/55/2005 was 256.

Supplemental Reactivity Information for Influenza Strains of Human, Swine and Avian Origin (analytical testing and in silico analyses):

Results of testing viral isolates or nucleic acid from viral culture indicate that the FilmArray RP pan-influenza and subtyping assays react with virus of swine and avian origin as expected (Table 19).

Host	Subtype	Isolate / Strain	TestConcentration	FilmArrayResult
Swine	H1N1	Influenza A/Swine/1976/31	~1 x 106 EID50/mL	Influenza A H1 a
	H1N1	Influenza A/Swine/Iowa/15/30	~1 x 107 EID50/mL
Avian	H1N2	Kilbourne F63A/NWS/34 (HA) x A/RockefellerInstitute/5/57 (NA)	14.8 ng RNA b	Influenza A H1

Table 19. Results of Inclusivity Testing with Swine and Avian Isolates of Influenza A

ª No reactivity was observed with the 2009 H1 subtyping assay or other FilmArray RP assays.

b Purified and quantified RNA from avian influenza culture was obtained from BEI Resources.

Laboratory testing of influenza A strains was supplemented with in silico predictions of reactivity using bioinformatics and sequence alignments between FilmArray RP assay primers and sequences for influenza A strains of human, swine, and avian origin. For each strain. multiple (3) GenBank IDs were evaluated, corresponding to the gene segments targeted by the FilmArray RP assays (matrix (MA), non-structural (NS) and hemagglutinin(HA)). Simulated reactivity was determined based on the number and location of mismatches in the targeted region. The strains listed in Table 20 are predicted to react with the FilmArray RP pan-influenza A and H1, H1-2009 or H3 subtyping assays as indicated.

{18}------------------------------------------------

Host	Subtype	Strain	GenBankID	SimulatedFilmArray RPReactivity
Human	H1N1	A/California/UR06-0393/2007(H1N1)	CY026540CY026543CY026539	Influenza A H1
	H1N1-2009	A/Aalborg/INS133/2009(H1N1)	CY063606CY063610CY063607	Influenza A H1-2009
	H1N2	A/New York/297/2003(H1N2)	CY002668CY002665CY002664	Influenza A H1
	H2N2	A/Albany/20/1957(H2N2)	CY022013CY022014CY022017	Influenza A(no subtypedetected)
	H3N2	A/Boston/38/2008(H3N2)	CY044581CY044584CY044580	Influenza A H3
	H5N1	A/Cambodia/R0405050/2007(H5N1)	HQ200572HQ200573FJ225472	Influenza A(no subtypedetected)
	H5N1	A/Hong Kong/486/97(H5N1)	AF084281AF255368AF115289	Influenza A(no subtypedetected)
	H7N2	A/New York/107/2003(H7N2)	EU587368EU587373EU587374	Influenza A(no subtypedetected)
	H7N3	A/Canada/rv504/2004(H7N3)	CY015006CY015007CY015010	Influenza A(no subtypedetected)
Swine	H7N7	A/Netherlands/219/03(H7N7)	AY340089AY342422AY338459	Influenza A(no subtypedetected)
	H9N2	A/Hong Kong/1073/99(H9N2)	AJ404626AJ278647AJ278649	Influenza A(no subtypedetected)
	H1N1	A/swine/Wisconsin/1/1971(H1N1)	CY022414CY022417CY022413	Influenza A H1
	H1N2	A/swine/Hong Kong/NS857/2001(H1N2)A/swine/Sweden/1021/2009(H1N2)	GQ229348GQ229350GQ229347GQ495135GQ495136GQ495132	Influenza A H1Influenza A(no subtypedetected)
Avian	H5N1	A/swine/East Java/UT6010/2007(H5N1)	HM440124HM440111HM440123	Influenza A(no subtypedetected)
	H2N2	A/chicken/New York/13828-3/1995(H2N2)A/Japan/305/1957(H2N2)	CY014822CY014825CY014821CY045804CY014977CY014980	Influenza A(no subtypedetected)
Host	Subtype	Strain	GenBankID	SimulatedFilmArray RPReactivity
		A/Korea/426/1968(H2N2)	CY031595	Influenza A
			CY031596	(no subtypedetected)
			CY031599
	H3N1	A/blue-winged teal/ALB/452/1983(H3N1)	CY004635
			CY004638	Influenza A H3
			CY005940
	H3N2	A/American black duck/North Carolina/675-075/2004(H3N2)	GU051135	Influenza A
			GU051136	(no subtypedetected)
			GU051137
	H3N5	A/mallard/Netherlands/2/1999(H3N5)	CY060261
			CY060264	Influenza A H3
			CY060265
	H3N6	A/American black duck/NewBrunswick/25182/2007(H3N6)	CY047696	Influenza A
			CY047697	(no subtypedetected)
			CY047700
	H3N7	A/northernshoveler/California/HKWF1367/2007(H3N7)	CY033372
			CY033375	Influenza A H3
			CY033376
	H3N8	A/American blackduck/Washington/699/1978(H3N8)	GU052299
			GU052302	Influenza A H3
			GU052300
	H4N6	A/blue-winged teal/Minnesota/Sg-00043/2007(H4N6)	CY063977	Influenza A
			CY063978	(no subtypedetected)
			CY063981
		A/rook/Rostov-on-Don/26/2007(H5N1)	EU814503	Influenza A(no subtypedetected)
			EU814504
			EU814507
	H5N1	A/turkey/VA/505477-18/2007(H5N1)	GU186509	Influenza A
			GU186510	(no subtypedetected)
			GU186513
		A/chicken/Bangladesh/1151-10/2010(H5N1)	HQ156765	Influenza A
			HQ156766	(no subtypedetected)
			HQ156764
	H5N2	A/duck/Pennsylvania/10218/1984(H5N2)	AB295603	Influenza A
			AB286120	(no subtypedetected)
			AB286652
	H5N3	A/duck/Singapore/F119/3/1997(H5N3)	GU052802	Influenza A
			GU052803	(no subtypedetected)
			GU052805
	H6N1	A/duck/PA/486/1969(H6N1)	EU743286	Influenza A
			EU743287	(no subtypedetected)
			EU743289
	H6N2	A/mallard/Czech Republic/15902-17K/2009(H6N2)	HQ244430	Influenza A
			HQ244433	(no subtypedetected)
			HQ244434
	H7N7	A/mallard/Korea/GH171/2007(H7N7)	FJ750872	Influenza A(no subtypedetected)
			FJ959087
			FJ959090
Host	Subtype	Strain	GenBankID	SimulatedFilmArray RPReactivity
			CY014664	(no subtypedetected)
			CY014667
	H10N7	A/chicken/Germany/N/1949(H10N7)	GQ176136	Influenza A
			GQ176135	(no subtypedetected)
			GQ176132
	H11N9	A/duck/Memphis/546/1974(H11N9)	CY014691	Influenza A
			GQ257441	(no subtypedetected)
			CY014687

Table 20. Simulated Reactivity of FilmArray Influenza A Assays with Human, Swine, and Avian Influenza Strains ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ -

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Table 20. Simulated Reactivity of FilmArray Influenza A Assays with Human, Swine, and Avian Influenza Strains

{20}------------------------------------------------

Table 20. Simulated Reactivity of FilmArray Influenza A Assays with Human, Swine, and Avian Influenza Strains

Table 21. Results of Inclusivity Testing for Influenza B

Strain	Concentration	Multiple of LoD
B/FL/04/06	60 TCID50/mL	1x
B/Ohio/01/2005CDC#2005743348	1:3,000,000 a	n/a
B/Florida/07/04	60 TCID50/mL	1x
B/Malaysia/2506/04	600 TCID50/mL	10x
B/Hong Kong/5/72 ATCC VR-823	60 TCID50/mL	1x
B/Taiwan/2/62 ATCC VR-295	60 TCID50/mL	1x
B/Maryland/1/59 ATCC VR-296	600 TCID50/mL	10x
B/GL/1739/54 ATCC VR-103	60 TCID50/mL	1x
B/Allen/45 ATCC VR-102	6,000 EID50/mL	n/a
B/Lee/40ATCC VR-101	60 TCID50/mL	1x
B/Brigit RecombinantATCC VR-786	60 TCID50/mL	1x

a Strain was not re-cultured and titered. Dilutions of the original culture/titer from the CDC were used. The HA titer for B/Ohio/01/2005 was 128.

				Table 22. Results of Inclusivity Testing for Parainfluenza Virus 3
--	--	--	--	--------------------------------------------------------------------	--

Type	Strain or Source	Concentration	Multiple of LoD
	Zeptometrix#0810016CF	10 TCID50/mL	X
3	C-243500 TCID50/mLATCC VR-93	50x
	NIH 47885BEI NR-3233	100 TCID50/mL	1 0x

{21}------------------------------------------------

Type	Strain or Source	Concentration	Multiple of LoD
	Zeptometrix#0810040ACF	2 TCID50/mL	1x
A	A/A2ATCC VR-1540	2 TCID50/mL	1x
	A/LongATCC VR-26	2 TCID50/mL	1x
	B/9320ATCC VR-955	2 TCID50/mL	1x
B	B/Wash18537/62ATCC VR-1580	2 TCID50/mL	1x
	B/WV/14617/85ATCC VR-1400	2 TCID50/mL	1x

Table 23. Results of Inclusivity Testing for Respiratory Syncytial Virus

Analytical Specificity (Cross-reactivity and Exclusivity)

The potential for cross-reactivity between assays contained in the FilmArray RP system was evaluated by testing simulated NPS samples containing high concentrations of respiratory panel viruses (tens to thousands-fold higher than LoD). No cross-reactivity was observed at the concentrations listed in Error! Reference source not found.24.

Virus or Bacterium	Type / Strain	Test Concentration	Multiple of LoD
Adenovirus	Serotype 1(Species C)	1.00x105 TCIDsc/mL	333 x
Coronavirus	HKU1 - Type BClinical specimen	2.78x109 copies/mL	1,463 x
	NL63NR-470	5.67x103 TCID50/mL	1,134 x
HumanMetapneumovirus	Type A1 - hMPV-16IA10-2003 A1	8.17x103 TCID50/mL	4.085 x
Human Rhinovirus /Enterovirus	Echovirus 6	3.40x106 TCID50/mL	113 x
	Rhinovirus Al	5.67x103 TCID50/mL	5,670 x
Influenza A	A/Brisbane/59/07	1.00x105 TCID50/mL	500 x
HINI	A/New Caledonia/20/99	1.00x105 TCID50/mL	500 x
	A/PR/8/34	1.00x106 TCID50/mL	5,000 x
	A1/FM/1/47	4.70x103 TCID50/mL	24 x
	A/NWS/33	4.70x103 TCID50/mL	24 x
	A1/Denver/1/57	4.70x103 TCID50/mL	24 x
	A/Solomon Islands/3/2006	1.39x104 TCID50/mL	70 x

Table 24. Results of Testing for Cross-Reactivity with FilmArray RP Analytes

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Virus or Bacterium	Type / Strain	Test Concentration	Multiple of LoD
Influenza AH1N1-2009	A/Weiss/43	4.70x103 TCID50/mL	24 x
	A/Mal/302/54	1.39x104 TCID50/mL	70 x
	A/SwineNY/03/2009	4.00x105 TCID50/mL	4,000 x
Influenza AH3N2	A/Wisconsin/67/2005	8.17x103 TCID50/mL	1634 x
	A/Victoria/3/75	4.70x103 TCID50/mL	940 x
	A/Port Chalmers/1/73	5.67x103 TCID50/mL	1,134 x
	A/Aichi/2/68	1.00x105 TCID50/mL	20,000 x
	A/Hong Kong/8/68	1.00x105 TCID50/mL	20,000 x
	A/Alice	4.70x103 TCID50/mL	940 x
	A/MRC 2	8.17x103 TCID50/mL	1,634 x
	A/Brisbane/10/07	8.17x103 TCID50/mL	1,634 x
Influenza B	B/FL/04/06	1.67x104 TCID50/mL	278 x
	B/Lee/40	8.17x103 TCID50/mL	136 x
	B/Taiwan/2/62	5.03x104 TCID50/mL	838 x
	B/GL/1739/54	8.17x103 TCID50/mL	136 x
	B/Maryland/1/59	8.17x103 TCID50/mL	136 x
	B/Florida/07/04	1.00x105 TCID50/mL	1,667 x
	B/Malaysia/2506/04	5.67x103 TCID50/mL	95 x
	B/Allen/45	1.00x105 TCID50/mL	1,667 x
	B/HongKong/5/72	8.17x103 TCID50/mL	136 x
Parainfluenza Virus	Type 3	1.00x105 TCID50/mL	10,000 x
Respiratory SyncytialVirus	A	1.39x104 TCID50/mL	6,950 x
	B	2.14x104 TCID50/mL	10,700 x

The potential for the FilmArray RP system to cross-react with non-FilmArray RP organisms was evaluated by testing an exclusivity panel consisting of 45 bacteria, 13 viruses, and 1 fungus. These organisms were selected based on their relatedness to FilmArray RP analytes, clinical relevance (cause respiratory symptoms or represent nasopharyngeal flora), or high prevalence within the population (e.g. Herpes Simplex Virus). Negative sample matrix was spiked with bacteria or fungi at a concentration of 106 CFU/mL and viruses at a concentration between 104 - 105 TCID50/mL, or the highest concentration possible. The FilmArray RP system did not cross-react with the exclusivity panel organisms listed in Table 25. One measles virus strain was found to contain Adenovirus, which was detected by the FilmArray RP.

Idaho Technology Inc. 510(k) FilmArray Respiratory Panel System

{23}------------------------------------------------

Bacteria	Strain / Isolate	Viruses	Strain / Isolate
Bordetella bronchiseptica	clinical isolate	Bocavirus	Type 1 - Clinical specimen
Bordetella holmesii	F061	Coronavirus 229E	ATCC VR-740
Bordetella parapertussis	A747	Coronavirus SARS	Zeptometrix - Nucleic Acid
Bordetella pertussis	E431	Coronavirus OC43	ATCC VR-759
Bordetella pertussis	A639	Cytomegalovirus (CMV)	AD-169 (VR-538)
Bordetella pertussis	ATCC 8467	Epstein-Barr Virus(EBV)	B95-8
Bordetella pertussis	ATCC 9797	Herpes Simplex Virus	Type 1
Bordetella pertussis	ATCC 51445	Parainfluenza Virus 1	Zeptometrix # 0810014CF
Bordetella pertussis	ATCC BAA-589	Parainfluenza Virus 2	Zeptometrix # 0810015CF
Bordetella pertussis	ATCC 9340	Parainfluenza Virus 4	Zeptometrix #0810060CF
Bordetella pertussis	ATCC 10380	Measles Virus	Edmonston
Bordetella pertussis	ATCC BAA-1335	Measles Virus	Zeptometrix # 0810025CFª
Chlamydia trachomatis	D-UW3	Mumps	Zeptometrix # 0810079CF
Chlamydophilapneumoniae	TW183	Fungi	Strain / Isolate
Corynebacteriumdiptheriae	ATCC14779	Candida albicans	Zeptometrix #0801504
Escherichia coli	O157:H7
Haemophilus influenzae	MinnA
Lactobacillus acidophilus	Type strain
Lactobacillus plantarum	17-5
Legionella longbeacheae	Long Beach 4
Legionella micdadei	Tatlock
Legionella pneumophilia	Philadelphia
Moraxella catarrhalis	Ne 11 (type strain)
Mycobacteriumtuberculosis	H37Ra-1
Mycoplasma hominis	ATCC 23114
Mycoplasma genitalium	ATCC 33530
Mycoplasma pneumoniae	M129
Mycoplasma pneumoniae	ATCC 15531
Mycoplasma pneumoniae	ATCC 15293
Mycoplasma pneumoniae	ATCC 15377
Mycoplasma pneumoniae	ATCC 15492
Mycoplasma pneumoniae	ATCC 29085
Mycoplasma pneumoniae	ATCC 29342
Mycoplasma pneumoniae	ATCC 39505
Mycoplasma pneumoniae	ATCC 49894

Table 25. Non-FilmArray RP Exclusivity Panel

{24}------------------------------------------------

Neisseria elongata	type strain
Neisseria gonorrhoeae	ATCC 700825
Neisseria meningitidis	M1027 (typestrain)
Pseudomonas aeruginosa	Zeptometrix#0801519
Staphylococcus aureus	COL
Staphylococcus epidermidis	RP62A
Streptococcus pneumoniae	type 59
Streptococcus pyogenes	Zeptometrix#0801512
Streptococcus salivarius	ATCC 13419
Ureaplasma urealyticum	ATCC 27618

4This viral stock produced one false positive Adenovirus result. The false positive was confirmed to be caused by Adenovirus contamination of the viral stock and was not due to cross-reactivity between the Adenovirus assay and Measles virus.

Supplemental Analytical Exclusivity Testing for Influenza Strains of Avian Origin:

Additional analytical exclusivity testing was carried out with either live isolates or purified genomic RNA of avian host influenza A strains with the following results:

Host	Subtype	Isolate / Strain	Test Concentrationa	FilmArray Result
Avian	H2N2	A/Japan/305/57	3.3 ng RNA	Influenza A(no subtype detected)
	H2N2	Kilbourne F38	6.3 ng RNA
	H2N2	A/Korea/426/68 (HA, NA) x A/Puerto Rico/8/34	6.3 ng RNA
	H5N1	A/Vietnam/1203/2004 R-H5	N/Ab
	H5N2	A/duck/Pennsylvania/10218/84	2.5 ng RNA
	H5N3	Kilbourne F181A/duck/Singapore/645/97	247 ng RNA
	H7N2	A/NewYork/107/2003	N/Ab
	H7N3	A/Mallard/Netherlands/12/2000	N/Ab
	H10N7	A/chicken/Germany/N/49	68 ng RNA

Table 26. Results of Exclusivity Testing of Virus or Nucleic Acid from Culture of Avian Influenza A

4 Purified and quantified RNA from avian influenza cultures was obtained from BEI Resources

6 Stock virus HA titre from CDC = 128. Twenty microliters of virus stock tested.

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Precision (Reproducibility)

A multicenter reproducibility study was performed to determine between-site and overall reproducibility of the FilmArray RP system.

Reproducibility testing occurred at three test sites utilizing a panel of twelve simulated NPS specimens spiked with various combinations of live respiratory pathogens (analytes) at three different test levels (high negative (LoD/10), low positive (1X LoD), and medium positive (3X LoD)). On each testing day, two operators at each site tested two aliquots of specimens on two different FilmArray instruments (six specimens per operator per instrument per day). Every specimen was tested four times a day on five days at the three testing sites. for a total of 60 tests per analyte per concentration. A total of 26 lots of reagents and 20 FilmArray instruments were utilized in the reproducibility study. Summary results for each analyte are summarized below.

Results for each analyte are summarized below:

AdenovirusSpecies C Serotype 1		#Positive	#Negative	% AgreementwithExpectedResulta	95%CI	MeanTm	%CVTm	ObservedTm Range
Medium Positive	Site A	20/20	0/20	100%	83.2% - 100%	83.74	0.24	83.33 - 84.26
(3X LoD)	Site B	20/20	0/20	100%	83.2% - 100%	84.23	0.21	83.95 - 84.60
	Site C	20/20	0/20	100%	83.2% - 100%	83.76	0.28	83.03 - 84.13
900 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%	83.93	0.36	83.03 - 84.60
Low Positive	Site A	20/20	0/20	100%	83.2% - 100%	83.42	0.28	83.01 - 83.98
(1X LoD)	Site B	20/20	0/20	100%	83.2% - 100%	83.90	0.26	83.54 - 84.30
	Site C	20/20	0/20	100%	83.2% - 100%	83.62	0.38	83.05 - 84.64
300 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%	83.64	0.39	83.01 - 84.64
High Negativeb	Site A	18/20	2/20	90.0%	68.3% - 98.8%	83.33	0.26	83.02 - 83.76
(LoD/10)	Site B	16/20	4/20	80.0%	56.3%-94.3%	83.71	0.30	82.93 - 84.29
	Site C	10/20	10/20	50.0%	27.2%-72.8%	83.26	0.31	82.61 - 83.86
30 TCID50/mL	All Sites	44/60	16/60	73.3%	60.3% - 83.9%	83.43	0.38	82.61 - 84.29
Negative	Site A	0/180	180/180	100.0%	98.0% - 100%
	Site B	0/180	180/180	100.0%	98.0% - 100%
	Site C	0/180	180/180	100.0%	98.0% - 100%
	All Sites	0/540	540/540	100.0%	99.3% - 100%

Summary of Positive Agreement, Negative Agreement, and Tm Reproducibility Testing of Single Assay Analytes

4 Expected results for the "Medium Positive", and the "High Negative" panel members are positive. Expected result for the "Negative" panel member is negative.

{26}------------------------------------------------

Coronavirus HKU1Type BClinical Specimen 6123		#Positive	#Negative	%AgreementwithExpectedResult *	95%CI	MeanTm	%CVTm	ObservedTm Range
Medium Positive	Site A	20/20	0/20	100%	83.2% - 100%	75.61	0.23	75.37 - 76.02
(3X LoD)	Site B	20/20	0/20	100%	83.2% - 100%	76.02	0.26	75.58 - 76.33
	Site C	20/20	0/20	100%	83.2% - 100%	75.49	0.32	74.96 - 75.90
5.7 x 10 6 RNAcopies/mL	All Sites	60/60	0/60	100%	94.0% - 100%	75.69	0.41	74.96 - 76.33
Low Positive	Site A	20/20	0/20	100%	83.2% - 100%	75.47	0.22	74.96 - 75.79
(1X LoD)	Site B	20/20	0/20	100%	83.2% - 100%	75.89	0.20	75.59 - 76.12
	Site C	20/20	0/20	100%	83.2% - 100%	75.35	0.30	74.83 - 75.81
1.9 x 10 6 RNAcopies/mL	All Sites	60/60	0/60	100%	94.0% - 100%	75.55	0.40	74.83 - 76.12
High Negativeb	Site A	15/20	5/20	75.0%	50.9% - 91.3%	75.51	0.28	75.06 - 75.90
(LoD/10)	Site B	17/20	3/20	85.0%	62.1% - 96.8%	75.85	0.22	75.26 - 76.23
	Site C	19/20	1/20	95.0%	75.1% - 99.9%	75.33	0.22	74.98 - 75.59
1.9 x 105 RNAcopies/mL	All Sites	51/60	9/60	85.0%	73.4% - 92.9%	75.55	0.38	74.98 - 76.23
	Site A	0/180	180/180	100%	98.0% - 100%
	Site B	0/180	180/180	100%	98.0% - 100%
Negative	Site C	0/180	180/180	100%	98.0% - 100%
	All Sites	0/540	540/540	100%	99.3% - 100%

4 Expected results for the "Medium Positive", the "Low Positive", and the "High Negative" panel members are possive. Expected result for the "Negative" panel member is negative.

6 High negative samples are targeted to be positive 20-80% of the time.

Coronavirus NL63BEI Resources NR-470		#Positive	#Negative	%AgreementwithExpectedResulta	95%CI	MeanTm	%CVTm	ObservedTm Range
Medium Positive	Site A	20/20	0/20	100%	83.2% - 100%	80.21	0.31	79.64 - 80.90
(3X LoD)	Site B	20/20	0/20	100%	83.2%-100%	80.55	0.33	79.99 - 81.03
	Site C	20/20	0/20	100%	83.2%-100%	80.04	0.25	79.67 - 80.62
15 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%	80.29	0.40	79.64 - 81.03
Low Positive	Site A	20/20	0/20	100%	83.2%-100%	80.08	0.25	79.57 - 80.42
(1X LoD)	Site B	20/20	0/20	100%	83.2%-100%	80.40	0.24	79.98 - 80.89
	Site C	20/20	0/20	100%	83.2%-100%	79.88	0.27	79.36 - 80.40
5 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%	80.12	0.38	79.14 - 80.89
High Negativeb	Site A	13/20	7/20	65.0%	40.8% - 84.6%	80.08	0.34	79.21 - 80.82
(LoD/10)	Site B	14/20	6/20	70.0%	45.7% - 88.1%	80.36	0.30	79.98 - 80.91
	Site C	10/20	10/20	50.0%	27.2% - 72.8%	79.91	0.26	79.24 - 80.30
0.5 TCID50/mL	All Sites	37/60	23/60	61.7%	48.2% - 73.9%	80.11	0.39	79.21 - 80.91
Negative	Site A	0/180	180/180	100%	98.0% - 100%
	Site B	0/180	180/180	100%	98.0% - 100%
	Site C	0/180	180/180	100%	98.0% - 100%
	All Sites	0/540	540/540	100%	99.3% - 100%

4 Expected results for the "Medium Positive", the "Low Positive", and the "High Negative" panel members are positive. Expected result for the "Negative" panel member is negative.

{27}------------------------------------------------

Human MetapneumovirushMPV-16 (A1)		#Positive	#Negative	%AgreementwithExpectedResulta	95%CI	MeanTm	%CVTm	ObservedTm Range
Medium Positive(3X LoD)	Site A	20/20	0/20	100%	83.2%-100%	77.61	0.23	77.06-77.90
	Site B	20/20	0/20	100%	83.2%-100%	78.07	0.28	77.67-78.61
	Site C	19/20	1/20	95.0%	75.1%-99.9%	77.73	0.21	77.45-78.11
6 TCID50/mL	All Sites	59/60	1/60	98.3%	91.1%-100%	77.82	0.36	77.06-78.61
Low Positive(1X LoD)	Site A	20/20	0/20	100%	83.2%-100%	77.39	0.21	77.04-77.79
	Site B	20/20	0/20	100%	83.2%-100%	77.88	0.22	77.37-78.11
	Site C	20/20	0/20	100%	83.2%-100%	77.60	0.24	77.16-77.99
2 TCID50/mL	All Sites	60/60	0/60	100%	94.0%-100%	77.62	0.35	77.04-78.11
High Negativeb(LoD/10)	Site A	17/20	2/20	85.0%	62.1%-96.8%	77.34	0.20	77.05-77.59
	Site B	19/20	6/20	95.0%	75.1%-99.9%	77.76	0.22	77.06-78.11
	Site C	12/20	4/20	60.0%	36.1%-80.9%	77.37	0.29	76.74-77.79
0.2 TCID50/mL	All Sites	48/60	12/60	80.0%	67.7%-89.2%	77.50	0.35	76.74-78.11
	Site A	0/180	180/180	100%	98.0%-100%
	Site B	0/180	180/180	100%	98.0%-100%
Negative	Site C	0/180	180/180	100%	98.0%-100%
	All Sites	0/540	540/540	100%	99.3%-100%

ª Expected results for the "Medium Positive", the "Low Positive", and the "High Negative" panel members are positive. Expected result for the "Negative" panel member is negative.

b High negative samples are targeted to be positive 20-80% of the time.

Influenza BB/FL/04/06	#Positive	#Negative	%AgreementwithExpectedResulta	95%CI	MeanTm	%CVTm	ObservedTm Range
Medium Positive(3X LoD)	Site A	20/20	0/20	100%	83.2% - 100%	80.47	0.26	79.88 - 80.93
	Site B	20/20	0/20	100%	83.2%-100%	80.88	0.31	80.30 - 81.30
	Site C	20/20	0/20	100%	83.2%-100%	80.36	0.32	79.78 - 80.80
180 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%	80.56	0.40	79.78 - 81.30
Low Positive(1X LoD)	Site A	20/20	0/20	100%	83.2%-100%	80.44	0.27	80.00 - 80.92
	Site B	20/20	0/20	100%	83.2%-100%	80.79	0.29	80.40 - 81.33
	Site C	20/20	0/20	100%	83.2% - 100%	80.34	0.22	79.77 - 80.81
60 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%	80.51	0.37	79.77 - 81.33
High Negativeb(LoD/10)	Site A	12/20	8/20	60.0%	36.1% - 80.9%	80.42	0.32	79.84 - 80.90
	Site B	10/20	10/20	50.0%	27.2% - 72.8%	80.78	0.25	80.40 - 81.17
	Site C	8/20	12/20	40.0%	19.1% - 64.0%	80.30	0.21	79.79 - 80.69
6 TCID50/mL	All Sites	30/60	30/60	50.0%	36.8% - 63.2%	80.50	0.36	79.79 - 81.17
Negative	Site A	0/180	180/180	100%	98.0% - 100%
	Site B	0/180	180/180	100%	98.0% - 100%
	Site C	0/180	180/180	100%	98.0% - 100%
	All Sites	0/540	540/540	100%	99.3% - 100%

ª Expected results for the "Medium Positive", the "Low Positive", and the "High Negative" pancl members are possive. Expected result for the "Negative" panel member is negative.

{28}------------------------------------------------

Parainfluenza Virus 3Zeptometrix #0810016CF		#Positive	#Negative	%AgreementwithExpectedResult *	95%CI	MeanTm	%CVTm	ObservedTm Range
Medium Positive	Site A	20/20	0/20	100%	83.2% - 100%	81.17	0.36	80.71 - 81.86
(3X LoD)	Site B	20/20	0/20	100%	83.2% - 100%	81.48	0.35	81.03 - 81.89
	Site C	20/20	0/20	100%	83.2% - 100%	80.94	0.28	80.63 - 81.37
30 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%	81.22	0.41	80.63 - 81.89
Low Positive	Site A	20/20	0/20	100%	83.2%-100%	80.97	0.36	80.36 - 81.52
(1X LoD)	Site B	20/20	0/20	100%	83.2% - 100%	81.35	0.26	80.93 - 81.79
	Site C	17/20	3/20	85.0%	62.1% - 96.8%	80.86	0.28	80.10 - 81.21
10 TCID50/mL	All Sites	57/60	3/60	95.0%	86.1% - 99.0%	81.08	0.40	80.10 - 81.79
High Negative®	Site A	10/20	10/20	50.0%	27.2% - 72.8%	80.99	0.26	80.30 - 81.34
(LoD/10)	Site B	7/20	13/20	35.0%	15.4% - 59.2%	81.29	0.28	80.61 - 81.77
	Site C	5/20	15/20	25.0%	8.7% - 49.1%	80.84	0.24	80.41 - 81.24
1 TCID50/mL	All Sites	22/60	38/60	36.7%	24.6% - 50.1%	81.05	0.34	80.30 - 81.77
	Site A	0/180	180/180	100%	98.0% - 100%
Negative	Site B	0/180	180/180	100%	98.0% - 100%
	Site C	0/180	180/180	100%	98.0% - 100%
	All Sites	0/540	540/540	100%	99.3% - 100%

4 Expected results for the "Medium Positive", the "Low Positive", and the "High Negative" panel members are positive. Expected result for the "Negative" panel member is negative.

b High negative samples are targeted to be positive 20-80% of the time.

Respiratory Syncytial VirusType A		#Positive	#Negative	%AgreementwithExpectedResult a	95%CI	MeanTm	%CVTm	ObservedTm Range
Medium Positive(3X LoD)	Site A	60/60	0/60	100%	94.0% - 100%	80.44	0.35	79.46 - 80.83
	Site B	60/60	0/60	100%	94.0% - 100%	80.86	0.25	80.41 - 81.56
	Site C	60/60	0/60	100%	94.0% - 100%	80.39	0.33	80.08 - 80.91
6 TCID50/mL	All Sites	180/180	0/180	100%	97.8% - 100%	80.58	0.40	79.46 - 81.56
Low Positive(1X LoD)	Site A	40/40	0/40	100%	91.2% - 100%	79.82	0.50	78.93 - 80.62
	Site B	40/40	0/40	100%	91.2% - 100%	80.40	0.46	79.47 - 81.03
	Site C	40/40	0/40	100%	91.2% - 100%	80.13	0.47	79.13 - 80.79
2 TCID50/mL	All Sites	120/120	0/120	100%	97.0% - 100%	80.10	0.57	78.93 - 81.03
High Negativeb(LoD/10)	Site A	18/20	2/20	90.0%	68.3% - 98.8%	79.63	0.50	78.72 - 80.72
	Site B	17/20	3/20	85.0%	62.1% - 96.8%	80.12	0.50	79.26 - 80.89
	Site C	11/20	9/20	55.0%	31.5% - 76.9%	79.97	0.57	78.83 - 80.84
0.2 TCID50/mL	All Sites	46/60	14/60	76.7%	64.0% - 86.6%	79.90	0.58	78.72 - 80.89
Negative	Site A	0/120	120/120	100%	97.0% - 100%
	Site B	0/120	120/120	100%	97.0% - 100%
	Site C	0/120	120/120	100%	97.0% - 100%
	All Sites	0/360	360/360	100%	99.0% - 100%

ª Expected results for the "Medium Positive", the "Low Positive", and the "High Negative" panel members are positive. Expected result for the "Negative" panel member is negative.

{29}------------------------------------------------

Summary of Positive Agreement, Negative Agreement, and Tm Reproducibility Testing of Multi-Assay Analytes

EnterovirusEchovirus 6 (Species B)		#Positive	#Negative	%Agreement withExpected Result *	95%CI
Medium Positive	Site A	20/20	0/20	100%	83.2% - 100%
(3X LoD)	Site B	20/20	0/20	100%	83.2% - 100%
	Site C	20/20	0/20	100%	83.2%-100%
90,000 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%
Low Positive	Site A	20/20	0/20	100%	83.2% - 100%
(1X LoD)	Site B	20/20	0/20	100%	83.2% - 100%
	Site C	20/20	0/20	100%	83.2%-100%
30,000 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%
High Negativeb	Site A	20/20	0/20	100%	83.2% - 100%
(LoD/10)	Site B	20/20	0/20	100%	83.2%-100%
	Site C	20/20	0/20	100%	83.2% - 100%
3,000 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%
	Site A	0/60	60/60	100%	94.0% - 100%
Negative	Site B	0/60	60/60	100%	94.0% - 100%
	Site C	0/60	60/60	100%	94.0% - 100%
	All Sites	0/180	180/180	100%	97.8% - 100%

Reproducibility Agreement Summary for Enterovirus (Human Rhinovirus/Enterovirus)

Expected results for the "Medium Positive", the "Low Positive", and the "High Negative" panel members are positive. Expected result for the "Negative" panel member is negative.

b High negative samples are targeted to be positive 20-80% of the time.

Reproducibility Tm Summary (by Assay) for Enterovirus

Assay	EnterovirusEchovirus 6 (Species B)		MeanTm	% CVTm	ObservedTm Range
	Medium Positive	Site A	87.12	0.24	86.79 - 87.73
	3x LoD	Site B	87.51	0.30	86.99 - 88.05
		Site C	86.98	0.33	86.37 - 87.64
	90,000 TCID50/mL	All Sites	87.18	0.39	86.37 - 88.05
	Low Positive	Site A	87.00	0.33	86.17 - 87.64
	1x LoD	Site B	87.36	0.29	86.80 - 87.85
Entero 1		Site C	86.81	0.35	86.15 - 87.41
	30,000 TCID50/mL	All Sites	87.05	0.42	86.15 - 87.85
	High Negative	Site A	86.89	0.29	86.06 - 87.40
	0.1x LoD	Site B	87.34	0.31	86.67 - 87.86
		Site C	86.67	0.29	85.97 - 87.30
	3,000 TCID50/mL	All Sites	86.96	0.44	85.97 - 87.86
Entero 2	Medium Positive	Site A	87.09	0.28	86.68 - 87.73
	3x LoD	Site B	87.47	0.30	86.82 - 88.00
		Site C	86.93	0.36	86.16 - 87.64
	90,000 TCID50/mL	All Sites	87.14	0.41	86.16 - 88.00
	Low Positive	Site A	86.98	0.30	86.28 - 87.53
	1x LoD	Site B	87.34	0.28	86.89 - 87.82
		Site C	86.77	0.35	86.05 - 87.52
	30,000 TCID50/mL	All Sites	87.02	0.41	86.05 - 87.82

Idaho Technology Inc. 510(k) FilmArray Respiratory Panel System

{30}------------------------------------------------

Assay	EnterovirusEchovirus 6 (Species B)		MeanTm	% CVTm	ObservedTm Range
	High Negative0.1x LoD	Site A	86.86	0.29	86.17 - 87.54
		Site B	87.26	0.35	86.59 - 87.94
		Site C	86.65	0.27	86.27 - 87.20
	3,000 TCID50/mL	All Sites	86.92	0.42	86.17 - 87.94
	Medium Positive3x LoD	Site A	85.70	0.31	85.21 - 86.18
		Site B	86.19	0.30	85.35 - 86.77
		Site C	85.59	0.34	84.91 - 86.19
	90,000 TCID50/mL	All Sites	85.81	0.44	84.91 - 86.77
HRV4	Low Positive1x LoD	Site A	85.45	0.26	84.81 - 86.06
		Site B	85.87	0.24	85.44 - 86.36
		Site C	85.32	0.40	84.69 - 86.26
	30,000 TCID50/mL	All Sites	85.54	0.40	84.69 - 86.36
	High Negative0.1x LoD	Site A	85.37	0.26	84.80 - 86.04
		Site B	85.82	0.23	85.43 - 86.23
		Site C	85.22	0.22	84.82 - 85.58
	3,000 TCID50/mL	All Sites	85.46	0.39	84.80 - 86.23

Reproducibility Agreement Summary for Rhinovirus (Human Rhinovirus/Enterovirus)

Human RhinovirusA1		#Positive	#Negative	%Agreement withExpected Resulta	95%CI
Medium Positive	Site A	60/60	0/60	100%	94.0% - 100%
(3X LoD)	Site B	60/60	0/60	100%	94.0% - 100%
	Site C	60/60	0/60	100%	94.0% - 100%
3 TCID50/mL	All Sites	180/180	0/180	100%	97.8% - 100%
Low Positive	Site A	20/20	0/20	100%	83.2%-100%
(1X LoD)	Site B	20/20	0/20	100%	83.2%-100%
	Site C	20/20	0/20	100%	83.2%-100%
1 TCID50/mL	All Sites	60/60	0/60	100%	94.0% - 100%
High Negativeb	Site A	40/40	0/40	100%	91.2% - 100%
(LoD/10)	Site B	40/40	0/40	100%	91.2% - 100%
	Site C	32/40	8/40	80.0%	64.4% - 91.0%
0.1 TCID50/mL	All Sites	112/120	8/120	93.3%	87.3% - 97.1%
	Site A	0/60	60/60	100%	94.0% - 100%
	Site B	0/60	60/60	100%	94.0% - 100%
Negative	Site C	0/60	60/60	100%	94.0% - 100%
	All Sites	0/180	180/180	100%	97.8% - 100%

" Expected results for the "Medium Positive", and the "High Negative" panel members are positive. Expected
result for the "Negative" panel member is negative.
" High negativ

^bHigh negative samples are targeted to be positive 20-80% of the time.

{31}------------------------------------------------

Reproducibility Tm Summary (by Assay) for Rhinovirus

Assay	Human Rhinovirus A1		Mean Tm	% CV Tm	Observed Tm Range
HRV1	Medium Positive 3x LoD	Site A	83.79	0.44	83.25 - 85.09
		Site B	84.06	0.31	83.43 - 84.56
		Site C	83.68	0.23	83.22 - 84.09
	3 TCID50/mL	All Sites	83.84	0.38	83.22 - 85.09
HRV1	Low Positive 1x LoD	Site A	83.71	0.29	83.07 - 84.35
		Site B	84.07	0.34	83.44 - 84.66
		Site C	83.93	0.34	83.24 - 84.71
	1 TCID50/mL	All Sites	83.90	0.37	83.07 - 84.71
HRV1	High Negative 0.1x LoD	Site A	83.56	0.28	83.02 - 84.26
		Site B	83.91	0.34	83.22 - 84.52
		Site C	83.76	0.31	83.04 - 84.48
	0.1 TCID50/mL	All Sites	83.74	0.36	83.02 - 84.52
HRV2	Medium Positive 3x LoD	Site A	83.33	0.48	82.55 - 84.67
		Site B	83.65	0.29	83.11 - 84.17
		Site C	83.30	0.28	82.70 - 83.77
	3 TCID50/mL	All Sites	83.42	0.41	82.55 - 84.67
HRV2	Low Positive 1x LoD	Site A	83.28	0.31	82.57 - 83.86
		Site B	83.66	0.36	83.02 - 84.37
		Site C	83.52	0.39	82.82 - 84.29
	1 TCID50/mL	All Sites	83.48	0.40	82.57 - 84.37
HRV2	High Negative 0.1x LoD	Site A	83.17	0.34	82.42 - 83.88
		Site B	83.58	0.36	82.80 - 84.31
		Site C	83.37	0.33	82.51 - 83.92
	0.1 TCID50/mL	All Sites	83.37	0.40	82.42 - 84.31
HRV3	Medium Positive 3x LoD	Site A	82.73	0.53	81.99 - 83.94
		Site B	83.25	0.36	82.49 - 83.88
		Site C	82.89	0.43	82.10 - 83.88
	3 TCID50/mL	All Sites	82.96	0.51	81.99 - 83.94
HRV3	Low Positive 1x LoD	Site A	82.67	0.49	81.76 - 83.65
		Site B	83.24	0.44	82.40 - 84.08
		Site C	83.07	0.41	82.13 - 83.76
	1 TCID50/mL	All Sites	82.98	0.54	81.76 - 84.08
HRV3	High Negative 0.1x LoD	Site A	82.68	0.50	81.78 - 83.67
		Site B	83.21	0.46	82.18 - 84.37
		Site C	82.97	0.42	81.85 - 83.64
	0.1 TCID50/mL	All Sites	82.96	0.52	81.78 - 84.37
HRV4	Medium Positive 3x LoD	Site A	83.81	0.38	83.28 - 84.98
		Site B	84.14	0.34	83.43 - 84.83
		Site C	83.80	0.25	83.44 - 84.20
	3 TCID50/mL	All Sites	83.90	0.37	83.28 - 84.98
HRV4	Low Positive 1x LoD	Site A	83.79	0.31	83.18 - 84.45
		Site B	84.08	0.31	83.55 - 84.61
		Site C	84.04	0.38	83.35 - 84.93
	1 TCID50/mL	All Sites	83.94	0.37	83.18 - 84.93
HRV4	High Negative 0.1x LoD	Site A	83.58	0.26	83.11 - 84.05
		Site B	83.88	0.31	83.34 - 84.49
		Site C	83.86	0.27	83.24 - 84.58
	0.1 TCID50/mL	All Sites	83.76	0.33	83.11 - 84.58

Idaho Technology Inc. 510(k)
FilmArray Respiratory Panel System

{32}------------------------------------------------

Influenza A H1N1A/Brisbane/59/07		#Positive	#Equivocal	#Negative	%Agreement withExpected Result a	95%CI
Medium Positive	Site A	20/20	0/20	0/20	100%	83.2%-100%
(3X LoD)	Site B	20/20	0/20	0/20	100%	83.2%-100%
	Site C	20/20	0/20	0/20	100%	83.2%-100%
600 TCID50/mL	All Sites	60/60	0/60	0/60	100%	94.0% - 100%
Low Positive	Site A	20/20	0/20	0/20	100%	83.2%-100%
(1X LoD)	Site B	19/20	1/20	0/20	95.0%	75.1% - 99.9%
	Site C	17/20	2/20	1/20	85.0%	62.1%-96.8%
200 TCID50/mL	All Sites	56/60	3/60	1/60	93%	83.8% - 98.2%
High Negativeb	Site A	20/20	0/20	0/20	100%	83.2%-100%
(LoD/10)	Site B	17/20	2/20	1/20	85.0%	62.1%-96.8%
	Site C	14/20	5/20	1/20	70.0%	45.7% - 88.1%
20 TCID50/mL	All Sites	51/60	7/60	2/60	85.0%	73.4% - 92.9%
	Site A	0/180	0/180	180/180	100%	98.0% - 100%
Negative	Site B	0/180	0/180	180/180	100%	98.0% - 100%
	Site C	0/180	0/180	180/180	100%	98.0% - 100%
	All Sites	0/540	0/540	540/540	100%	99.3% - 100%

Reproducibility Agreement Summary for Influenza A/H1

4 Expected results for the "Medium Positive", and the "High Negative" panel members are positive. Expected result for the "Negative" panel member is negative.

6 High negative samples are targeted to be positive 20-80% of the time.

Reproducibility Tm Summary (by Assay) for Influenza A/H1

Assay	Influenza A H1N1A/Brisbane/59/07		MeanTm	% CVTm	ObservedTm Range
FluApan1	Moderate Positive3x LoD	Site A	84.67	0.24	84.27-85.12
		Site B	85.10	0.24	84.78-85.56
		Site C	84.64	0.34	83.76-85.23
	600 TCID50/mL	All Sites	84.80	0.37	83.76-85.56
FluApan1	Low Positive1x LoD	Site A	84.57	0.27	84.17-85.31
		Site B	85.01	0.28	84.59-85.75
		Site C	84.68	0.26	84.16-85.18
	200 TCID50/mL	All Sites	84.75	0.34	84.16-85.75
FluApan1	High Negative0.1x LoD	Site A	84.27	0.26	83.85-84.81
		Site B	84.75	0.23	84.29-85.32
		Site C	84.46	0.35	83.89-85.48
	20 TCID50/mL	All Sites	84.48	0.37	83.85-85.48
FluApan2	Moderate Positive3x LoD	Site A	80.42	0.25	79.78-80.63
		Site B	80.85	0.27	80.39-81.26
		Site C	80.31	0.28	79.89-80.72
	600 TCID50/mL	All Sites	80.52	0.39	79.78-81.26
FluApan2	Low Positive1x LoD	Site A	80.36	0.23	79.99-80.73
		Site B	80.80	0.21	80.42-81.15
		Site C	80.52	0.22	80.19-80.89
	200 TCID50/mL	All Sites	80.57	0.32	79.99-81.15
FluApan2	High Negative0.1x LoD	Site A	79.91	0.37	79.15-80.41
		Site B	80.49	0.30	79.67-80.83
		Site C	80.10	0.35	79.56-80.73
	20 TCID50/mL	All Sites	80.17	0.45	79.15-80.83
FluAH1-pan	Moderate Positive3x LoD	Site A	78.79	0.25	78.31-79.25
		Site B	79.20	0.31	78.30-79.57
		Site C	78.76	0.39	77.79-79.25
	600 TCID50/mL	All Sites	78.91	0.42	77.67-79.57

{33}------------------------------------------------

Influenza A H1N1A/Brisbane/59/07	MeanTm	% CVTm	ObservedTm Range
Low Positive1x LoDSite A	78.77	0.25	78.42 - 79.34
Site B	79.20	0.27	78.72 - 79.67
Site C	78.80	0.25	78.30 - 79.26
200 TCID50/mLAll Sites	78.93	0.36	78.30 - 79.67
High Negative0.1x LoDSite A	77.65	0.33	77.15 - 78.21
Site B	78.18	0.45	77.47 - 79.26
Site C	77.93	0.49	77.43 - 79.04
20 TCID50/mLAll Sites	77.92	0.51	77.15 - 79.26

Reproducibility Agreement Summary for Influenza A/2009 H1

Influenza A 2009 H1N1A/Swine NY/03/2009		#Positive	#Equivocal	#Negative	% Agreement withExpected Resulta	95%CI
Medium Positive(3X LoD)	Site A	20/20	0/20	0/20	100%	83.2%-100%
	Site B	20/20	0/20	0/20	100%	83.2%-100%
	Site C	20/20	0/20	0/20	100%	83.2%-100%
300 TCID50/mL	All Sites	60/60	0/60	0/60	100%	94.0%-100%
Low Positive(1X LoD)	Site A	20/20	0/20	0/20	100%	83.2%-100%
	Site B	20/20	0/20	0/20	100%	83.2%-100%
	Site C	20/20	0/20	0/20	100%	83.2%-100%
100 TCID50/mL	All Sites	60/60	0/60	0/60	100%	94.0%-100%
High Negativeb(LoD/10)	Site A	20/20	0/20	0/20	100%	83.2%-100%
	Site B	19/20	1/20	0/20	95.0%	75.1%-99.9%
	Site C	20/20	0/20	0/20	100%	83.2%-100%
10 TCID50/mL	All Sites	59/60	1/60	0/60	98.3%	91.1%-100%
Negative	Site A	0/180	0/180	180/180	100%	98.0%-100%
	Site B	0/180	0/180	180/180	100%	98.0%-100%
	Site C	0/180	0/180	180/180	100%	98.0%-100%
	All Sites	0/540	0/540	540/540	100%	99.3%-100%

4 Expected results for the "Medium Positive", the "Low Positive", and the "High Negative" panel members are positive. Expected result for the "Negative" panel member is negative.

b High negative samples are targeted to be positive 20-80% of the time.

Reproducibility Tm Summary (by Assay) for Influenza A/2009 H1

Assay	Influenza A 2009 H1N1A/Swine NY/03/2009	MeanTm	% CVTm	ObservedTm Range
FluApan1	Moderate Positive3x LoD Site A	84.67	0.24	84.27 - 85.12
	Site B	85.10	0.24	84.78 - 85.56
	Site C	84.64	0.34	83.76 - 85.23
	300 TCID50/mL All Sites	84.80	0.37	83.76 - 85.56
	Low Positive1x LoD Site A	84.57	0.27	84.17 - 85.31
	Site B	85.01	0.28	84.59 - 85.75
	Site C	84.68	0.26	84.16 - 85.18
	100 TCID50/mL All Sites	84.75	0.34	84.16 - 85.75
	High Negative0.1x LoD Site A	84.27	0.26	83.85 - 84.81
	Site B	84.75	0.23	84.29 - 85.32
	Site C	84.46	0.35	83.89 - 85.48
	10 TCID50/mL All Sites	84.48	0.37	83.85 - 85.48
FluApan2	Moderate Positive3x LoD Site A	80.62	0.20	80.31 - 80.83
	Site B	81.01	0.17	80.70 - 81.36
	Site C	80.69	0.23	80.19 - 81.02
	300 TCID50/mL All Sites	80.81	0.32	80.19 - 81.36

{34}------------------------------------------------

	Influenza A 2009 H1N1A/Swine NY/03/2009		MeanTm	% CVTm	ObservedTm Range
Assay
	Low Positive1x LoD	Site A	80.39	0.29	79.87 - 80.73
		Site B	80.91	0.27	80.20 - 81.24
		Site C	80.30	0.17	80.05 - 80.61
	100 TCID50/mL	All Sites	80.62	0.44	79.87 - 81.24
	High Negative0.1x LoD	Site A	80.43	0.27	80.08 - 81.03
		Site B	80.72	0.27	80.11 - 81.14
		Site C	80.41	0.34	79.86 - 80.82
	10 TCID50/mL	All Sites	80.54	0.34	79.86 - 81.14
	Moderate Positive3x LoD	Site A	78.87	0.40	78.20 - 79.56
		Site B	79.44	0.35	78.94 - 79.99
		Site C	78.62	0.43	77.92 - 79.44
	300 TCID50/mL	All Sites	78.97	0.58	77.92 - 79.99
FluAH1-pan	Low Positive1x LoD	Site A	78.37	0.30	77.89 - 79.24
		Site B	78.90	0.37	78.21 - 79.76
		Site C	78.16	0.25	77.83 - 78.69
	100 TCID50/mL	All Sites	78.47	0.51	77.78 - 79.76
	High Negative0.1x LoD	Site A	78.34	0.37	77.90 - 79.37
		Site B	78.83	0.37	77.99 - 79.68
		Site C	78.08	0.27	77.68 - 78.51
	10 TCID50/mL	All Sites	78.40	0.53	77.68 - 79.68
	Moderate Positive3x LoD	Site A	78.73	0.24	78.31 - 79.14
		Site B	79.20	0.24	78.84 - 79.67
		Site C	78.54	0.30	77.89 - 78.92
	300 TCID50/mL	All Sites	78.81	0.44	77.89 - 79.67
FluAH1-2009	Low Positive1x LoD	Site A	78.64	0.26	78.10 - 79.14
		Site B	79.03	0.25	78.53 - 79.48
		Site C	78.49	0.24	78.12 - 78.82
	100 TCID50/mL	All Sites	78.71	0.39	78.10 - 79.48
	High Negative0.1x LoD	Site A	78.60	0.28	77.90 - 79.04
		Site B	79.00	0.23	78.52 - 79.36
		Site C	78.52	0.28	78.10 - 78.93
	10 TCID50/mL	All Sites	78.70	0.38	77.90 - 79.36

Reproducibility Agreement Summary for Influenza A/H3

Influenza A H3N2A/Wisconsin/67/2005		#Positive	#Equivocal	#Negative	%Agreement withExpected Result a	95%CI
Medium Positive(3X LoD)	Site A	20/20	0/20	0/20	100%	83.2%-100%
	Site B	20/20	0/20	0/20	100%	83.2%-100%
	Site C	20/20	0/20	0/20	100%	83.2%-100%
15 TCID50/mL	All Sites	60/60	0/60	0/60	100%	94.0%-100%
Low Positive(1X LoD)	Site A	20/20	0/20	0/20	100%	83.2%-100%
	Site B	20/20	0/20	0/20	100%	83.2%-100%
	Site C	20/20	0/20	0/20	100%	83.2%-100%
5 TCID50/mL	All Sites	60/60	0/60	0/60	100%	94.0%-100%
High Negativeb(LoD/10)	Site A	3/20	11/20	6/20	15.0%	3.2% - 37.9%
	Site B	4/20	12/20	4/20	20.0%	5.7%-43.7%
	Site C	3/20	8/20	9/20	15.0%	3.2% - 37.9%
0.5 TCID50/mL	All Sites	10/60	31/60	19/60	16.7%	8.3%-28.5%
	Site A	0/180	0/180	180/180	100%	98.0%-100%
	Site B	0/180	0/180	180/180	100%	98.0%-100%
Negative	Site C	0/180	0/180	180/180	100%	98.0%-100%
	All Sites	0/540	0/540	540/540	100%	99.3%-100%

ª Expected results for the "Medium Positive", the "Low Positive", and the "High Negative" panel members are positive. Expected result for the "Negative" panel member is negative.

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Assay	Influenza A H3N2A/Wisconsin/67/2005		MeanTm	% CVTm	ObservedTm Range
FluApan1	Moderate Positive3x LoD	Site A	85.33	0.26	84.79 - 85.73
		Site B	85.48	0.42	84.91 - 86.27
		Site C	85.06	0.38	84.50 - 85.40
	15 TCID50/mL	All Sites	85.36	0.38	84.50 - 86.27
	Low Positive1x LoD	Site A	84.95	0.41	84.19 - 86.03
		Site B	85.31	0.31	84.79 - 86.02
		Site C	84.83	0.26	84.37 - 85.25
	5 TCID50/mL	All Sites	85.03	0.41	84.19 - 86.03
	High Negative0.1x LoD	Site A	84.91	0.39	84.22 - 85.60
		Site B	85.24	0.30	84.78 - 85.77
		Site C	84.86	0.27	84.48 - 85.33
	0.5 TCID50/mL	All Sites	85.01	0.37	84.22 - 85.77
FluApan2	Moderate Positive3x LoD	Site A	79.75	0.25	79.51 - 79.99
		Site B	79.94	0.30	79.40 - 80.37
		Site C	79.60	0.24	79.14 - 79.86
	15 TCID50/mL	All Sites	79.81	0.33	79.14 - 80.37
	Low Positive1x LoD	Site A	79.42	0.31	79.00 - 80.30
		Site B	79.69	0.35	79.14 - 80.29
		Site C	79.25	0.20	78.82 - 79.59
	5 TCID50/mL	All Sites	79.45	0.37	78.82 - 80.30
	High Negative0.1x LoD	Site A	79.22	0.35	78.64 - 79.75
		Site B	79.59	0.29	79.05 - 79.99
		Site C	79.24	0.20	78.84 - 79.54
	0.5 TCID50/mL	All Sites	79.35	0.36	78.64 - 79.99
FluAH3	Moderate Positive3x LoD	Site A	82.58	0.35	81.87 - 83.01
		Site B	82.89	0.19	82.60 - 83.11
		Site C	82.44	0.33	81.98 - 82.81
	15 TCID50/mL	All Sites	82.62	0.39	81.87 - 83.11
	Low Positive1x LoD	Site A	82.32	0.29	81.88 - 82.69
		Site B	82.69	0.34	82.16 - 83.32
		Site C	82.21	0.25	81.76 - 82.73
	5 TCID50/mL	All Sites	82.39	0.41	81.67 - 83.32
	High Negative0.1x LoD	Site A	82.28	0.36	81.71 - 82.91
		Site B	82.61	0.29	82.17 - 83.05
		Site C	82.20	0.23	81.87 - 82.57
	0.5 TCID50/mL	All Sites	82.37	0.36	81.71 - 83.05

Reproducibility Tm Summary (by Assay) for Influenza A/H3

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Precision (Repeatability)

The repeatability of the FilmArray RP System results was evaluated by repeated testing of the same 12 specimens tested in the reproducibility study while minimizing as many sources of variability as possible. The in-house repeatabilty testing was performed at Site C over the course of 12 testing days for a total of 48 test results per specimen. On each day, all 12 specimens were tested 4 times by two operators on two FilmArray instruments.

Spiked Organism	Moderate Positive(3x LoD)		Low Positive(1x LoD)		High Negative(0.1x LoD)
	# Positive /Total	% PositiveResults	# Positive /Total	% PositiveResults	# Positive /Total	% PositiveResults
Adenovirus	48/48	100.0%	48/48	100.0%	34/48	70.8%
Coronavirus HKU1	48/48	100.0%	48/48	100.0%	44/48	91.7%
Coronavirus NL63	48/48	100.0%	48/48	100.0%	27/48	56.3%
Human Metapneumovirus	47/48	97.9%	48/48	100.0%	32/48	66.7%
Enterovirus	48/48	100.0%	48/48	100.0%	48/48	100%
Human Rhinovirus	144/144	100.0%	47/48	97.9%	83/96	86.5%
Influenza A/H1	48/48	100.0%	43/48a	89.6%a	39/48b	81.3%b
Influenza A/2009 H1N1	48/48	100.0%	48/48	100.0%	47/48c	97.9%c
Influenza A/H3	48/48	100.0%	48/48	100.0%	7/48d	14.6%d
Influenza B	48/48	100.0%	48/48	100.0%	25/48	52.1%
Parainfluenza Virus 3	48/48	100.0%	41/48	85.4%	14/48	29.2%
Respiratory Syncytial Virus	144/144	100.0%	96/96	100.0%	32/48	66.7%
% positive (all analytes)per test level	767/76899.9%		611/62497.9%		432/62469.2%

Table 27. Summary of Positive Agreement Results for Repeatability Testing

4 The five (5) non-positive results for Influenza A/H1 at LoD include: (1) Influenza A/H1 equivocal and (3) Influenza A equivocal results.

6 The nine (9) non-positive results for Influenza A/H1 at 0.1 x LoD include: (1) Negative, (3) Influenza A (no subtype detected), (1) Influenza A/H1 equivocal, and (4) Influenza A equivocal results.

€ One (1) equivocal Influenza A/H1-2009 result at the 0.1 x LoD test level.

d The 42 non-positive results for Influenza A/H3 at 0.1 x LoD include: (18) Negative, (2) Influenza A (no subtype detected) (15) Influenza A H3 equivocal, and (7) Influenza A equivocal results.

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Interference

Substances that could be present in NPS samples or introduced during sample handling were evaluated for their potential to interfere with assay performance. Four different organism mixes containing FilmArray RP analytes were spiked into a simulated NPS (sNPS) sample matrix (human epithelial cells in VTM) at 5 x their respective LoDs. The 5x LoD organism concentration was chosen to be near the analyte LoD but also to provide consistent results for sample-to-sample comparison. Each FilmArray RP analyte was tested in the presence of each potentially interfering substance listed in Table . None of the substances tested were found to compete or interfere with the control or analyte assays in the FilmArray RP.

Endogenous Substances	Competitive / Interfering Microorganisms
Human Blood (with Na Citrate) (1% v/v)	Respiratory Syncytial Virus A $2.8 x 10^4$ TCID50/mL
Mucin (bovine submaxillary gland) (1% v/v)	Human Rhinovirus $1.1 x 10^4$ TCID50/mL
Human Genomic DNA: 0.2 ng/µL	Influenza A 2009 H1N1 $1.0 x 10^5$ TCID50/mL
2 ng/µL	Staphylococcus aureus $1.0 x 10^6$ CFU/mL
20 ng/µL	Neisseria meningitides $1.0 x 10^6$ CFU/mL
	Corynebacterium diptheriae $1.0 x 10^6$ CFU/mL
Exogenous Substances
Saline Nasal Spray with Preservatives (1% v/v)	Analgesic ointment (1% w/v)
Nasal Decongestant Spray (Oxymetazoline HCl) (1%v/v)	Petroleum Jelly (1% w/v)
Tobramycin (0.6 mg/mL)	Smokeless Tobacco (1% w/v)
Mupirocin (2% w/v)
Technique Specific Substances
Laboratory Reagents:	Viral Transport Media:	Swabs:
Bleach (1%, 2%, 5% v/v)	Remel M4	Copan 168C (rayon / twisted aluminum shaft)
Disinfecting wipes	Remel M4-RT	Copan FloQ (flocked nylon / plastic shaft)
Ethanol (7% v/v)	Remel M5	Copan 175KS01 (polyester / aluminum shaft)
DNAzap (1% v/v)	Remel M6	Millipore 519CS01M (flocked nylon / plastic shaft)
RNaseOut (1% v/v)	Copan UTM

	Table 28. List of Potentially Interfering Substances Evaluated
--	----------------------------------------------------------------	--	--	--

Evaluation of the FilmArray RP system was not performed using clinical NPS specimens obtained from individuals who had recently received the FluMist® nasal influenza vaccine (MedImmune). However, analytical testing was performed with simulated samples containing various concentrations of the 2009-2010 formulation of the vaccine material. The FilmArray RP assays react with the Influenza A H1, Influenza A H3 and Influenza B viral material contained in the vaccine (Table 29). No cross-reactivity was observed with other, non-influenza FilmArray RP assays.

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FluMist®2009-2010(% v/v)	Adenovirus	CoronavirusHKUI	CoronavirusNL63	HumanMetapneumovirus	Human Rhinovirus /Enterovirus	Influenza A			Influenza B	Parainfluenzavirus 3	Respiratory SyncytialVirus
						H1	H1-2009	H3
10%	-	-	-	-	-	+	-	+	+	-	-
1%	-	-	-	-	-	+	-	+	+	-	-
0.1%	-	-	-	-	-	+	-	+	+	-	-
0.01%	-	-	-	-	-	+	-	+	+	-	-
0.001%	-	-	-	-	-	+	-	+	+	-	-
0.0001%	-	-	-	-	-	-	-	Equiva	+	-	-
0.00001%	-	-	-	-	-	-	-	-	+	-	-
0.000001%	-	-	-	-	-	-	-	-	-	-	-

Table 29. Evaluation of FluMist® Nasal Vaccine as a Potentially Interfering Substance

ª Equivocal Influenza A/H3 result

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Image /page/39/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. To the left of the bird, there is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Beth Lingenfelter, M.S.
Director, Regulated Products
Idaho Technology Inc.
390 Wakara Way
Salt Lake City, UT 84108

FEB 17 2011

Re:	K103175
Trade/Device Name:	FilmArray Respiratory Panel (RP) System
Regulation Number:	21 CFR §866.3980
Regulation Name:	Respiratory Viral Panel Multiplex Nucleic Acid Assay
Regulatory Class:	Class II
Product Codes:	OCC, OEM, OOU, OEP, OTG, NXD, OOI
Dated:	February 2, 2011
Received:	February 3, 2011

Dear Ms. Lingenfelter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{40}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.1.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Uwe Schif for

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K103175 Device Name: FilmArray Respiratory Panel (RP) System

Indications for Use:

Due to seasonal prevalence, performance characteristics for Influenza A/H1, Influenza A/H3, Influenza A/2009 H1, and Influenza B were established primarily with retrospective clinical specimens.

{42}------------------------------------------------

A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Districting Officer

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) < 103175

Regulation Number and Section

§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.

(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.