K Number
K103175
Device Name
FILMARRAY RESPIRATORY PANEL (RP)
Date Cleared
2011-02-17

(112 days)

Product Code
Regulation Number
866.3980
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The description focuses on the biochemical and mechanical processes of the device (nucleic acid purification, PCR, melt analysis) and the software's role in interpreting these results based on predefined criteria (DNA melting curve analysis, internal controls). There is no mention of the software learning from data or using algorithms that adapt over time, which are hallmarks of AI/ML.

No
This device is a diagnostic tool used to detect and identify multiple respiratory viral nucleic acids, aiding in the diagnosis of respiratory infections. It does not provide treatment or therapy.

Yes

This device is a diagnostic device as its intended use is to detect and identify multiple respiratory viral nucleic acids to aid in the diagnosis of respiratory infection, when used in conjunction with other clinical and epidemiological information.

No

The device description clearly states that the FilmArray RP System is composed of the FilmArray instrument, the FilmArray software, and the FilmArray RP pouch, indicating it includes hardware components (instrument and pouch) in addition to software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states that the device 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." This describes a test performed on a biological sample (nasopharyngeal swab) outside of the body (in vitro) to aid in diagnosis.
  • Purpose: The purpose is to "aid in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information." This directly aligns with the definition of an IVD, which is used to provide information for diagnosis, monitoring, or treatment.
  • Sample Type: The device uses "nasopharyngeal swabs (NPS)," which are biological specimens.
  • Methodology: The device performs "multiplexed nucleic acid test," "nucleic acid purification, reverse transcription, and nested, multiplex PCR with DNA melt analysis." These are laboratory techniques performed on biological samples.
  • Device Description: The description details a system involving an instrument, software, and a pouch containing reagents to perform the testing. This is characteristic of an IVD system.

The information provided clearly indicates that the FilmArray Respiratory Panel is a test performed on biological samples outside of the body to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

OCC, OEM, OOU, OEP, OTG, NXD, OOI

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.

Mentions image processing

A digital camera placed in front of the second stage PCR captures fluorescent images of the PCR reactions in real time.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasopharyngeal swabs (NPS)

Indicated Patient Age Range

The summary indicates subjects studied were across all age groups, specifically: ≤5 years, 6-21 years, 22-49 years, and ≥50 years.

Intended User / Care Setting

The device is intended for prescription use, but the summary does not explicitly state the intended user or care setting. However it mentions 'clinical sites' for the performance study.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Clinical Performance Study:

  • Sample Size: 853 subjects in the prospective study.
  • Data Source: Nasopharyngeal swabs (NPS) collected from individuals suspected of respiratory tract infections at 3 U.S. clinical sites. A second respiratory sample was collected for viral culture reference testing.
  • Annotation Protocol:
    • Performance evaluated by comparing FilmArray RP results with comparator/reference methods (Viral culture followed by DFA identification, PCR test with bi-directional sequence confirmation, or an algorithm using composite comparator methods with two analytically validated PCR assays followed by bi-directional sequencing).
    • "True" positives and negatives were defined based on the comparator methods.

Testing of Preselected Archived Specimens:

  • Sample Size: 349 confirmed specimens out of 400 initially.
  • Data Source: Archived clinical NPS specimens previously tested positive for specific organisms (Adenovirus, Enterovirus, Influenza A/H1, 2009 H1N1, H3, Influenza B, Parainfluenza Virus 3) or negative by previous methods.
  • Annotation Protocol: Presence or absence of the analyte of interest was confirmed using analyte specific PCR and bi-directional sequencing. Users testing with FilmArray RP were blinded to expected results.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Performance Study:

  • Study Type: Prospective clinical study.
  • Sample Size: 853 subjects.
  • Standalone Performance: The study evaluated the FilmArray RP's ability to detect various viruses in nasopharyngeal swabs compared to reference methods.
  • Key Results:
    • High sensitivity and specificity for most analytes. For example, Respiratory Syncytial Virus showed 100% sensitivity (52/52) and 89.1% specificity (714/801).
    • Detected 81 mixed infections (16.1% of total positive specimens), with Human Rhinovirus/Enterovirus and Respiratory Syncytial Virus being the most common co-infection.
    • Most positive results were detected in children 5 years or younger.
    • Performance for Influenza A/H1, A/H3, A/2009 H1, and Influenza B was established primarily with retrospective clinical specimens due to seasonal prevalence.

Testing of Preselected Archived Specimens:

  • Study Type: Evaluation of archived clinical specimens.
  • Sample Size: 349 confirmed specimens.
  • Standalone Performance: The study evaluated the positive percent agreement (PPA) and negative percent agreement (NPA) of the FilmArray RP against pre-confirmed analytes.
  • Key Results: Achieved 100% PPA for Adenovirus, FluA/H1, FluA/H1-2009, FluA/H3, Influenza B, and PIV3 where tested; and 100% NPA for all tested analytes. Enterovirus showed 95.7% PPA (22/23).

Selected Analytic Studies:

  • Limit of Detection (LoD): Determined for each analyte by testing limiting dilutions of live, quantified viruses (or clinical specimen for Coronavirus HKU1). LoD is defined as the lowest concentration consistently detected (≥95% detection).
  • Analytical Reactivity (Inclusivity): Evaluated with a panel of 99 strains/isolates representing genetic, temporal, and geographic diversity. All 99 strains were reactive. Adenovirus C serotype 6 showed 10,000-fold less reactivity than expected LoD.
  • Analytical Specificity (Cross-reactivity and Exclusivity):
    • Evaluated by testing simulated NPS samples with high concentrations of other respiratory panel viruses (no cross-reactivity observed).
    • Evaluated against an exclusivity panel of 45 bacteria, 13 viruses, and 1 fungus (no cross-reactivity observed, except for Adenovirus contamination in one measles virus strain).
  • Precision (Reproducibility): Multicenter study (3 sites) using panels of simulated NPS specimens spiked at high negative (LoD/10), low positive (1X LoD), and medium positive (3X LoD) levels. Overall agreement and Tm reproducibility were summarized for each analyte. Most analytes showed high positive and negative agreement.
  • Precision (Repeatability): In-house repeatability testing (Site C) over 12 days for 48 test results per specimen. Showed high positive agreement, especially at higher concentrations.
  • Interference: Evaluated potential interference from endogenous substances, competitive/interfering microorganisms, exogenous substances, and technique-specific substances. No interference observed. FluMist® nasal influenza vaccine was also tested, showing reactivity for Influenza A H1, A H3, and Influenza B, but no cross-reactivity with non-influenza assays.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Clinical Study (Table 6):

  • Adenovirus: Sensitivity 88.9% (24/27), Specificity 98.3% (812/826)
  • Influenza A: Sensitivity 90.0% (9/10), Specificity 99.8% (841/843)
  • Influenza A/H1: Sensitivity n/a (0/0), Specificity 100% (853/853)
  • Influenza A/H3: Sensitivity n/a (0/0), Specificity 100% (853/853)
  • Influenza A/2009 H1: Sensitivity 88.9% (8/9), Specificity 99.6% (841/844)
  • Influenza B: Sensitivity n/a (0/0), Specificity 100% (853/853)
  • Parainfluenza Virus 3: Sensitivity 95.8% (23/24), Specificity 98.8% (819/829)
  • Respiratory Syncytial Virus: Sensitivity 100% (52/52), Specificity 89.1% (714/801)
  • Coronavirus HKU1: PPA 95.8% (23/24), NPA 99.8% (827/829)
  • Coronavirus NL63: PPA 95.8% (23/24), NPA 100% (829/829)
  • Human Metapneumovirus: PPA 94.6% (88/93), NPA 99.2% (754/760)
  • Human Rhinovirus/Enterovirus: PPA 92.7% (190/205), NPA 94.6% (613/648)

Archived Specimen Study (Table 10):

  • Adenovirus: PPA 100.0% (27/27), NPA 100.0% (28/28)
  • Enterovirus: PPA 95.7% (22/23), NPA 100.0% (90/90)
  • FluA/H1: PPA 100.0% (32/32), NPA 100.0% (127/127)
  • FluA/H1-2009: PPA 100.0% (34/34), NPA 100.0% (125/125)
  • FluA/H3: PPA 100.0% (54/54), NPA 100.0% (105/105)
  • Influenza B: PPA 100.0% (30/30), NPA 100.0% (129/129)
  • PIV3: PPA 100.0% (36/36), NPA 100.0% (93/93)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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:

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

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

1

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.

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).

2

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

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.

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

3

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.

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 Test
System | Luminex® xTAG™ RVP |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Organisms
Detected | Influenza A, Influenza A subtype H1,
Influenza A subtype H3, Influenza B,
Respiratory Syncytial Virus, human
Metapneumovirus, Adenovirus,
Parainfluenza 3, and
Rhinovirus/Enterovirus | Same
See below for differences |
| Analyte | RNA/DNA | Same |
| Technological
Principles | multiplex nucleic acid | Same
See below for differences |
| Specimen
Types | 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 Test
System | Luminex® xTAG™ RVP |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Organisms
Detected | Can distinguish Influenza A subtype 2009
H1 from Influenza A subtype H1.
Also detects Coronavirus NL63 and
Coronavirus HKU1. | Can distinguish Respiratory Syncytial Virus
Type A from Respiratory Syncytial Virus
Type B. Detects Parainfluenza virus 1 and
Parainfluenza virus 2. |
| Technological
Principles | Nested multiplex RT-PCR followed by high
resolution melting analysis to confirm
identity of amplified product. | Multiplex RT-PCR and multiplex TSPE
followed by Fluorescence-activated sorting
of labeled beads coupled to streptavidin-
conjugated biotinylated products |
| Instrumentation | FilmArray Instrument | PCR Thermocycler
Luminex® 100 IS or 200 system |
| Time to result | Less than 1 hour | Approximately 8 hours |
| Test
Interpretation | Automated test interpretation and report
generation. User cannot access raw data. | Semi-automated test interpretation. User
must review all "no call" results to
determine cause and retesting strategy. |
| Sample
Preparation
Method | Sample Processing is automated in the
FilmArray instrument. | Up front sample processing is required to
extract nucleic acid. |

4

| Element | FilmArray Respiratory Panel Test
System | Luminex® xTAG™ RVP |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Reagent
Storage | Reagents are stored at room temperature. | Reagents stored at 4°C and -20°C. |
| Controls | Two controls are included in each reagent
pouch to control for sample processing and
both stages of PCR and melt analysis. | Internal control added to each sample.
External control processed with each batch
of samples. |
| User
Complexity | 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.

SexNumber of Subjects
Male449 (53%)
Female404 (47%)
Age
≤5484 (57%)
6-2195 (11%)
22-49190 (22%)
≥5084 (10%)

Table 4. Demographic Summary for FilmArray RP Prospective Study

5

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/VirusReference/Comparator Method(s)
Adenovirus
Influenza AViral culture followed by DFA
identification1
Influenza B
Parainfluenza virus 3
Respiratory Syncytial Virus
FluA/H1 subtyping1 PCR test of influenza A positive viral
FluA/H3 subtypingculture with bi-directional sequence
FluA/2009 H1subtypingconfirmation2
Human Rhinovirus
Enterovirus2 PCR tests of patient specimen with bi-
Coronavirus NL63directional 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.

6

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.

Sensitivity95% CISpecificity95% CI
Adenovirus24/27a88.9%70.8 - 97.7%812/826b98.3%97.2 - 99.1%
Influenza A9/1090.0%55.5 - 99.8%841/843d99.8%99.2 - 100%
Influenza A/H10/0n/an/a853/853100%99.6 - 100%
Influenza A/H30/0n/an/a853/853100%99.6 - 100%
Influenza A/2009 H18/988.9%51.8 - 99.7%841/844d99.6%99.0 - 99.9%
Influenza B0/0n/an/a853/853100%99.6 - 100%
Parainfluenza Virus 323/24e95.8%78.9 - 99.9%819/829f98.8%97.8 - 99.4%
Respiratory Syncytial Virus52/52100%93.2 - 100%714/801g89.1%86.8 - 91.2%
PPA95% CINPA95% CI
Coronavirus HKU123/2495.8%78.9 - 99.9%827/829c99.8%99.1 - 100%
Coronavirus NL6323/2495.8%78.9 - 99.9%829/829100%99.6 - 100%
Human Metapneumovirus88/9394.6%87.9 - 98.2%754/76099.2%98.3 - 99.7%
Human Rhinovirus/Enterovirus190/20592.7%88.2 - 95.8%613/64894.6%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.

7

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 | Number
of
Positive
Samples | Percentage
of Total
Samples
Tested | Organism | Number of
Mixed
Infections | Prevalence
in Mixed
Infections |
|-----------------------------------|-------------------------------------|---------------------------------------------|--------------|----------------------------------|--------------------------------------|
| 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

8

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 | 6-21
years | 22-49
years | ≥ 50
years |
|------------------------------|-----------------------|-----------|---------------|----------------|---------------|
| 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 Specimens349
SexFemale (%)82 (23.5%)
Male (%)79 (22.6%)
Unknown188(53.9%)
AgeAvg14.1
Median4.0
Min0.5
Max83.0
Age Range≤589 (25.5%)
6-2135 (10.0%)
22-4923 (6.6%)
≥5014 (4.0%)
Unknowna188(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 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.

38

| FluMist®
2009-2010
(% v/v) | Adenovirus | Coronavirus
HKUI | Coronavirus
NL63 | Human
Metapneumovirus | Human Rhinovirus /
Enterovirus | Influenza A | | | Influenza B | Parainfluenza
virus 3 | Respiratory Syncytial
Virus |
|----------------------------------|------------|---------------------|---------------------|--------------------------|-----------------------------------|-------------|-------------|--------|-------------|--------------------------|--------------------------------|
| | | | | | | 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

.

39

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

41

Indications for Use

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

Indications for Use:

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

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)