Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a multiplex nucleic acid test system using standard molecular biology techniques (PCR, melt analysis) and automated fluid handling. The software interprets results based on DNA melting curve analysis and internal controls, which is a deterministic process, not indicative of AI/ML. There is no mention of AI, ML, or related concepts in the document.

Therapeutic

No
The device is a diagnostic tool that identifies the presence of specific nucleic acids for respiratory infections. It aids in diagnosis but does not directly treat or manage a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device aids in the "diagnosis of respiratory infection" when used in conjunction with other clinical and epidemiological information.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the FilmArray RP System is composed of the FilmArray instrument, the FilmArray software, and the FilmArray RP pouch, indicating it is a system with significant hardware components (instrument and pouch) in addition to the software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section 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 and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections." This clearly describes a test performed in vitro (outside the body) on a biological specimen (nasopharyngeal swab) to aid in diagnosis.
Device Description: The description details a system that processes a biological sample (NPS) using reagents and instrumentation to detect specific analytes (viral and bacterial nucleic acids). This is characteristic of an IVD.
Performance Studies: The document includes detailed descriptions of clinical performance studies, testing of archived specimens, and testing of contrived specimens, all of which are standard evaluations for IVD devices to demonstrate their accuracy and reliability in a clinical setting.
Key Metrics: The reporting of metrics like sensitivity (PPA) and specificity (NPA) are crucial for evaluating the performance of an IVD.
Predicate Devices: The mention of predicate devices (K103175 and K110764 - FilmArray Respiratory Panel (RP) System) indicates that this device is being compared to previously cleared IVDs with similar intended uses.

All of these elements strongly support the classification of this device as an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the FilmArray RP: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms; the agent(s) detected by the Film Array RP may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.
Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis, Coronavirus 229E, Coronavirus OC43, Influenza A/H1, Influenza A/H3, Influenza A/2009 H1, Influenza B, Mycoplasma pneumoniae Parainfluenza Virus 1, Parainfluenza Virus 2, and Parainfluenza Virus 4 were established primarily with retrospective clinical specimens. Performance characteristics for Chlamydophila pneumoniae were established primarily using contrived clinical specimens.

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 2 and 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).

The FilmArray RP assay for Coronavirus OC43 may cross-react with some isolates of Coronavirus HKU1. A dual positive result may be due to cross-reactivity or may indicate a co-infection.

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

OCC, OEM, OOU, OEP, OTG, NXD, OOI, OZZ, OZY, OZX

Device Description

The FilmArray RP System is a 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 20 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 specimen/Sample Buffer Mix rehydrates the reagents. After the pouch is prepared, the FilmArray software guides the user though the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

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.

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nasopharyngeal swabs (NPS)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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: 1117 subjects (initially 1144 enrolled, 4 withdrawn, 20 omitted due to improper storage, 3 omitted due to external control failures).
Data source: Nasopharyngeal swabs (NPS) collected during a prospective study at 3 U.S. clinical sites (December 2009 - May 2010 and September 2010 - January 2011). Subjects exhibited signs and/or symptoms of respiratory infection.
Annotation protocol: FilmArray RP results compared to a predetermined algorithm using composite comparator methods consisting of two analytically validated PCR assays followed by bi-directional sequencing. "True" positives were samples with bi-directional sequencing data meeting quality acceptance criteria and matching NCBI GenBank sequences. "True" negatives were samples negative by both comparator PCR assays.

Testing of Preselected Archived Specimens:

Sample size: 305 archived clinical NPS specimens.
Data source: Archived clinical NPS specimens previously tested positive for B. pertussis, Coronavirus 229E, Coronavirus OC43, or M. pneumoniae.
Annotation protocol: Analyte content confirmed using analyte-specific PCR and bi-directional sequencing. Confirmation testing results were used for final analysis, overriding previous lab results. Specimens were organized into blinded "test panels" for FilmArray RP testing.

Testing of Contrived C. pneumoniae Specimens:

Sample size: 100 contrived C. pneumoniae specimens (50 spiked, 50 unspiked).
Data source: Residual NPS specimens from the prospective clinical evaluation, spiked with C. pneumoniae at clinically relevant levels.
Annotation protocol: Analyte status of each contrived specimen was blinded to users analyzing the specimens.

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

Clinical Performance Study (Prospective Clinical Study):

Study Type: Prospective clinical study.
Sample Size: 1117 subjects.
Standalone Performance (Agreement with Comparator Methods):
- Coronavirus 229E: PPA = 100% (12/12), NPA = 99.8% (1103/1105).
- Coronavirus OC43: PPA = 100% (14/14), NPA = 99.6% (1098/1103).
- B. pertussis: PPA = 100% (6/6), NPA = 99.9% (1110/1111).
- C. pneumoniae: PPA = 100% (1/1), NPA = 100% (1116/1116).
- M. pneumoniae: PPA = 100% (4/4), NPA = 100% (1113/1113).
Key Results: High positive and negative percent agreement for all additional organisms compared to composite comparator methods. Detected 121 co-infections (10.8% of all analyzed specimens), with 21 involving the newly added organisms. Cross-reactivity observed between Coronavirus OC43 and HKU1 was noted. Most detections (60%) were in children 5 years and younger.

Testing of Preselected Archived Specimens:

Study Type: Evaluation of preselected archived clinical NPS specimens.
Sample Size: 305 specimens.
Standalone Performance (Agreement with Confirmation Testing):
- B. pertussis: PPA = 94.6% (53/56), NPA = 96.5% (56/58).
- Coronavirus 229E: PPA = 100% (13/13), NPA = 95.7% (45/47).
- Coronavirus OC43: PPA = 100% (24/24), NPA = 91.7% (33/36).
- M. pneumoniae: PPA = 84.4% (54/64), NPA = 89.2% (58/56).
Key Results: Generally high agreement. Discrepancies were often investigated and resolved, with some false positives determined to be actual positives upon further investigation, and some false negatives attributed to low analyte levels in archived samples.

Testing of Contrived C. pneumoniae Specimens:

Study Type: Evaluation of contrived specimens.
Sample Size: 100 specimens (50 spiked, 50 unspiked).
Standalone Performance:
- C. pneumoniae: PPA = 100% (50/50), NPA = 100% (50/50).
Key Results: Demonstrated 100% positive and negative agreement for contrived C. pneumoniae specimens.

Limit of Detection (LoD) Study:

Study Type: Analytical sensitivity study.
Key Results:
- CoV OC43: 600 TCID50/mL
- CoV 229E: 4 TCID50/mL
- B. pertussis: 4000 CFU/mL
- C. pneumoniae: 3000 DNA copies/mL
- M. pneumoniae: 30 TCID50/mL

Analytical Reactivity (Inclusivity) Study:

Study Type: Analytical reactivity study for inclusivity.
Key Results: All tested strains/isolates of CoV OC43, CoV 229E, B. pertussis, C. pneumoniae, and M. pneumoniae were detected at or near their respective LoD concentrations.

Analytical Specificity (Cross-reactivity and Exclusivity) Study:

Study Type: Analytical specificity study for cross-reactivity and exclusivity.
Key Results: No cross-reactivity was observed with high concentrations of other respiratory panel viruses and bacteria. The FilmArray RP system did not cross-react with 25 bacteria, 8 viruses, and 1 fungus in the exclusivity panel, with one false positive for Adenovirus confirmed to be due to contamination in the viral stock.

Precision (Reproducibility and Repeatability) Study:

Study Type: Multicenter reproducibility study and repeatability study.
Sample Size: 60 tests per analyte per concentration at 3 sites (reproducibility); additional 7 days of testing at one site (repeatability).
Key Results:
- Reproducibility (Overall Sites):
  - CoV OC43: Medium Positive (100%), Low Positive (100%), High Negative (80.0%), Negative (99.8%).
  - CoV 229E: Medium Positive (100%), Low Positive (100%), High Negative (53.3%), Negative (100%).
  - B. pertussis: Medium Positive (100%), Low Positive (100%), High Negative (66.7%), Negative (100%).
  - C. pneumoniae: Medium Positive (100%), Low Positive (98.3%), High Negative (58.3%), Negative (100%).
  - M. pneumoniae: Medium Positive (100%), Low Positive (93.3%), High Negative (33.3%), Negative (100%).
- Repeatability (Overall Positive Agreement Results):
  - CoV OC43: Moderate Positive (100%), Low Positive (97.9%), High Negative (68.8%).
  - CoV 229E: Moderate Positive (100%), Low Positive (100%), High Negative (39.6%).
  - B. pertussis: Moderate Positive (100%), Low Positive (100%), High Negative (56.3%).
  - C. pneumoniae: Moderate Positive (100%), Low Positive (95.8%), High Negative (37.5%).
  - M. pneumoniae: Moderate Positive (100%), Low Positive (97.9%), High Negative (39.6%).
- Tm (Melting Temperature) results show low %CV for positive samples, indicating consistent results.

Interference Study:

Study Type: Evaluation of potential interfering substances.
Key Results: None of the tested endogenous, exogenous substances, laboratory reagents, viral transport media, or swabs were found to interfere with the FilmArray RP assays.

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

Clinical Study (Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)):

Analyte	PPA (TP/TP+FN)	Percent	NPA (TN/TN+FP)	Percent
Coronavirus 229E	12/12	100%	1103/1105	99.8%
Coronavirus OC43	14/14	100%	1098/1103	99.6%
B. pertussis	6/6	100%	1110/1111	99.9%
C. pneumoniae	1/1	100%	1116/1116	100%
M. pneumoniae	4/4	100%	1113/1113	100%

Archived Specimen Study (Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)):

Analyte	PPA (TP/TP+FN)	Percent	NPA (TN/TN+FP)	Percent
B. pertussis	53/56	94.6%	56/58	96.5%
Coronavirus 229E	13/13	100%	45/47	95.7%
Coronavirus OC43	24/24	100%	33/36	91.7%
M. pneumoniae	54/64	84.4%	58/56	89.2%

Contrived C. pneumoniae Specimens (Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)):

Analyte	PPA (TP/TP+FN)	Percent	NPA (TN/TN+FP)	Percent
C. pneumoniae	50/50	100%	50/50	100%

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.

K103175, K110764

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

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.

Summary

0

120267

MAY 1 5 2012

510(k) Summary

510(k) Summary Idaho Technology Inc.

Modification of FilmArray® Respiratory Panel (RP) to add assays for Coronavirus OC43, Coronavirus 229E, Bordetella pertussis, Mycoplasma pneumoniae and Chlamydophila pneumoniae

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: January 27, 2012

Device Name and Classification:

Trade Name: FilmArray® Respiratory Panel (RP)

Regulation Number: 21 CFR 866.3980, 21 CFR 866.3065, 21 CFR 866.3375, and 21 CFR.3120

Classification Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay, Bordetella spp. serologic reagents, Mycoplasma spp. serologic reagents, and Chlamydia serological reagents

Predicate Device:

K 103175 and K110764 - FilmArray Respiratory Panel (RP) System

1

Intended Use:

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 and bacterial nucleic acids in nasopharvngeal swabs (NPS) . . obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the FilmArray RP: Adenovirus. Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamvdophila pneumoniae, and Myconlasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms; the agent(s) detected by the Film Array RP may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.
Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis, Coronavirus 229E, Coronavirus OC43, Influenza A/H1, Influenza A/H3, Influenza A/2009 H1, Influenza B, Mycoplasma pneumoniae Parainfluenza Virus 1, Parainfluenza Virus 2, and Parainfluenza Virus 4 were established primarily with retrospective clinical specimens. Performance characteristics for Chlamydophila pneumoniae were established primarily using contrived clinical specimens.

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 2 and 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).

The FilmArray RP assay for Coronavirus OC43 may cross-react with some isolates of Coronavirus HKU1. A dual positive result may be due to cross-reactivity or may indicate a co-infection.

2

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. Performance of detecting influenza A may vary if other influenza A strains are circulating or a novel influenza A virus emerges. 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 a 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 20 common and emerging viral respiratory pathogens (see Table 1),

Viral Respiratory Pathogens
Influenza A
H1 subtype
H3 subtype
2009 H1 subtype
Influenza B
Adenovirus
Coronavirus 229E
Coronavirus HKU1
Coronavirus NL63
Coronavirus OC43
Human Metapneumovirus
Parainfluenza Virus 1
Parainfluenza Virus 2
Parainfluenza Virus 3
Parainfluenza Virus 4
Respiratory Syncytial Virus
Rhinovirus and Enterovirus
Bacterial Respiratory Pathogens
Bordetella pertussis
Chlamydophila pneumoniae
Mycoplasma pneumoniae

Table 1. Organisms Detected by the FilmArray Respiratory Panel

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 specimen/Sample Buffer Mix rehydrates the reagents. After the pouch is prepared, the

3

FilmArray software guides the user though the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

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.

Substantial Equivalence:

The FilmArray Respiratory Panel System is substantially equivalent to the FilmArray Respiratory Panel System K103175 (cleared on February 17, 2011) and K110764 (cleared on April 27, 2011). Both were determined to be class II devices.

The following tables compare the FilmArray RP to the previously cleared FilmArray RP (K103175 and K110764). The first table outlines the similarities between the two systems and the following table outlines the differences.

4

| Element | New Device:
FilmArray Respiratory Panel System | Predicate:
FilmArray Respiratory Panel System
(K103175 and K110764) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Analyte | RNA/DNA | Same |
| Technological
Principles | Multiplex nucleic acid | Same |
| Specimen Types | Nasopharyngeal swabs | Same |
| Technological
Principles | Nested multiplex RT-PCR followed by high
resolution melting analysis to confirm
identity of amplified product. | Same |
| Instrumentation | FilmArray Instrument | Same |
| Time to result | Less than 1 hour | Same |
| Test
Interpretation | Automated test interpretation and report
generation. User cannot access raw data. | Same |
| Sample
Preparation
Method | Sample Processing is automated in the
FilmArray instrument. | Same |
| Reagent Storage | Reagents are stored at room temperature. | Same |
| Controls | Two controls are included in each reagent
pouch to control for sample processing and
both stages of PCR and melt analysis. | Same |
| User
Complexity | Moderate/Low | Same |

Similarities between the New Device and the Predicate.

. Differences between the New Device and the Predicate.

,

·

| Element | New Device:
FilmArray Respiratory Panel System | Predicate:
FilmArray Respiratory Panel System
(K103175 and K110764) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Organisms
Detected | Same as predicate with additional
organisms: Mycoplasma pneumoniae,
Chlamydophila pneumoniae, Bordetella
pertussis, Coronavirus 229E, and
Coronavirus OC43. | Influenza A, Influenza A subtype H1,
Influenza A subtype H3, Influenza A
subtype 2009 H1, Influenza B, Respiratory
Syncytial Virus, Human Metapneumovirus,
Adenovirus, Parainfluenza 1, Parainfluenza
2, Parainfluenza virus 3, Parainfluenza 4,
Rhinovirus/Enterovirus, Coronavirus HKU1
and Coronavirus NL63. |

·

.

1

5

Summary of Performance Data for Coronavirus 229E, Coronavirus OC43, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae

Clinical Performance

The clinical performance of the FilmArray RP system for Coronavirus 229E, Coronavirus OC43, B. pertussis, C. pneumoniae, and M. pneumoniae was established during a prospective study at 3 U.S. clinical sites where enrollment spanned an 11 month time period encompassing two respiratory seasons (December 2009 - May 2010 and September 2010 - January 2011). 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 1144 subjects were initially enrolled in the study (857 between December 2009 and May 2010; 287 between September 2010 and January 2011) and four were withdrawn. Specimens from 20 subjects were omitted from analysis due to improper storage prior to testing, and three specimens were omitted due to external control failures on the day of testing. Table 2 provides a summary of demographic information for the remaining 1117 subjects that participated in the prospective study.

Sex	Number of Subjects
Male	600 (54%)
Female	517 (46%)
Age
≤5	719 (64%)
6-21	124 (11%)
22-49	190 (17%)
≥50	84 (8%)

Table 2. Demographic Summary for FilmArray RP Prospective Study

Each NPS specimen was tested with the FilmArray RP. The performance of the FilmArray RP for Coronavirus 229E, Coronavirus OC43, B. pertussis, C. pneumoniae, and M. pneumoniae was evaluated by comparing the FilmArray RP test result for each virus or bacteria with the appropriate comparator/reference methods shown in Table 3.

6

Organism/Virus	Reference/Comparator Method(s)
Coronavirus 229E
Coronavirus OC43
Bordetella pertussis	. 2 PCR tests of patient specimen with bi-
directional sequence confirmation'
Chlamydophila pneumoniae
Mycoplasma pneumoniae

Table 3. Reference/Comparator Methods Used to Assess FilmArray RP performance

Performance of the FilmArray RP system detecting Coronavirus OC43, Bordelella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae, respectively, was compared to a predecemined algorithm that used composite comparator 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" positives were considered as any sample that had bi-directional sequencing data meeting pre-defined quality acceptance criteria that matched sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.ncbi.nlm.nih.gov) with acceptable E-values. "True" negatives were considered as any sample that tested negative by both of the comparator PCR assays.

A total of 1117 specimens were evaluated for Coronavirus 229E, Coronavirus OC43, B. pertussis, C. pneumoniae, and M. pneumoniae 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 or negative percent agreement (NPA) 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 4.

	Positive Percent Agreement		Negative Percent Agreement
Analyte	TP/TP + FN	Percent	95% CI	TN/TN + FPª	Percent	95% CI
Coronavirus 229E	12/12	100%	73.5-100%	1103/1105ª	99.8%	99.4-100%
Coronavirus OC43	14/14	100%	76.8-100%	1098/1103b.c	99.6%	99.0-99.9%
B. pertussis	6/6	100%	54.1-100%	1110/1111	99.9%	99.5-100%
C. pneumoniae	1/1	100%	n/a	1116/1116	100%	99.7-100%
M. pneumoniae	4/4	100%	39.8-100%	1113/1113	100%	99.7-100%

Table 4. Clinical Sensitivity and Specificity for the Film Array RP Prospective Clinical Study

CoV-229E was identified by bi-directional sequence analysis in 1/2 false positive specimens using an alternate പ. assav.

CoV-OC43 was detected in 2/5 false positive specimens using an alternate assay with bi-directional sequence b. analysis.

2/5 false positives were determined to be cross-reactive products derived from amplification of CoV-HKU) virus с. nucleic acid with the CoV-OC43 assay primers.

7

A total of 121 co-infections (10.8% of all analyzed specimens; 121/117) were detected by FilmArray during this study. The FilmArray detected 21 co-infections involving Coronavirus 229E, Coronavirus OC43, B. pertussis, C. pneumoniae, and M. pneumoniae (Table 5), representing approximately 17.4% of all co-infections detected (21/121).

| Distinct Co-infection Combinations
Detected by FilmArray RP | | | Co-infections | Number of
Discrepant
Co-infectionsa | Discrepant Analyte(s)a |----------------------------------------------------------------|--------- | Analyte 1 | Analyte 2 | CoV OC43 | HRV/Enterob | - | CoV OC43 | RSV (2)c |
| CoV OC43 | CoV HKU1 | - | CoV OC43 | Adenovirus | - | CoV OC43 | hMPV | CoV 229E | Adenovirus | RSV | CoV 229E | CoV NL63 | CoV 229E | HRV/Entero | - | CoV 229E | RSV | B. pertussis | HRV/Enterob | - | B. pertussis | Adenovirus | HRV/Entero | C. pneumoniae | Adenovirus | - | M. pneumoniae | PIV 2 | - | | Discrepant Analytes = 12/46 | | Total
|
----|-------------------------|-----------|------------------------|-------------------------------------------|------------------------------------------------------------------------|
| Analyte 3 | Analyte 4 | | | |
| - | 5 | 0 | |
| - | - | 3 | 3 | CoV OC43 (2)c, RSV
| - | 2 | 2 | CoV OC43c,d |
| - | 1 | 0 | |
| - | - | 1 | 0 | |
| - | 1 | 1 | Adenoc, RSVc |
| HRV/Entero | RSV | 1 | 1 | CoV 229Ec, RSVc |
| - | 1 | 0 | |
| - | - | 1 | 0 | |
| - | 2 | 1 | HRV/Entero |
| - | 1 | 1 | Adenoc, B. pertussis c |
| - | 1 | 0 | |
| - | 1 | 0 | |
| Total Co-infections: 21 | | | | Total Analytes in 21 Co-infections = 46

Table 5. Co-infections Involving CoVs OC43, CoV 229E, B. pertussis, C. pneumoniae, and M. pneumoniae as Detected by FilmArray RP

A discrepant co-infection or discrepant analyte was defined as one that was detected by FilmArray RP but not ત. detected by the reference/comparator methods,

b. HRV/Entero was not analyzed by a comparator method for 1/2 of the B. pertussis + HRV/Entero, or any of the HRV/Entero CoV OC43 co-infections due to the HRV/Entero analyte being cleared (K103175) prior to testing of these specimens.

These 11 discrepant analytes were investigated using bi-directional sequence analysis; 6/11 analytes were c. detected. Those not detected included 1 Adenovirus and 1 B. pertussis (Adeno/B. pertussis/HRV-Entero infection), 1 RSV (1 COV-OC43/RSV infection) and 2 CoV-OC43 (2 CoV-HKU1/CoV-OC43 infections).

d. Both discrepant CoVOC43 results were false-positive due to cross-reactivity of the OC43 assay with HKU1 viruses in the specimens. Users will be notified of the possibility of cross-reactivity when both of these CoVs are reported as detected in the same specimen.

Table 6 provides a summary of the FilmArray RP test results for Coronavirus 229E, Coronavirus OC43, B. pertussis, C. pneumoniae, and M. pneumoniae obtained during this study, including the prevalence of each organism detected by the FilmArray RP System and distribution among the age groups. The majority of Coronavirus 229E, Coronavirus OC43, B. pertussis, C. pneumoniae, and M. pneumoniae organisms were detected in children five years and younger (60%; 27/45). Of the remaining organisms 11% (5/45) were detected in subjects 6-21 years of age, 20% (9/45) in subjects 22-49 years of age, and 9% (4/45) in subjects ≥ 50 years of age.

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| Analyte | Total
(Expected
Value) | ≤ 5 years | 6-21
years | 22-49
years | ≥ 50
years |
|------------------|------------------------------|-----------|---------------|----------------|---------------|
| Coronavirus 229E | 14 (1.2%) | 6 | 2 | 5 | 1 |
| Coronavirus OC43 | 19 (1.7%) | 13 | 2 | 2 | 2 |
| B. pertussis | 7 (0.6%) | 5 | 1 | 0 | 1 |
| C. pneumoniae | 1 (0.09%) | 1 | 0 | 0 | 0 |
| M. pneumoniae | 4 (0.4%) | 2 | 0 | 2 | 0 |

Table 6. Prevalence and Age Distribution of Analytes in the Clinical Study

All five organisms were of low prevalence during the clinical study (0.09 - 1.7%). 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 B. pertussis, Coronavirus 229E, Coronavirus OC43, or M. pneumoniae. The analyte content of each specimen was confirmed using analyte-specific PCR and bi-directional sequencing; the results of confirmation testing (positive or negative for a particular analyte) were used for the final analysis regardless of the previous laboratory test result.

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 7, and Table 8 shows the performance data summary for B. pertussis, Coronavirus 229E, Coronavirus OC43, and M. pneumoniae, and the results of confirmation testing for each analyte are detailed in the footnotes of Table 8.

Total Specimens	305
Sex	Female (%)	126 (41.3%)
	Male (%)	131 (43%)
	Unknowna	48 (15.7%)
Age	Avg	13
	Median	7
	Min	0.5

Table 7. Demographic Summary of FilmArray RP Archived Specimen Study
----------------------------------------------------------------------	--	--

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	Max	91
	≤5	141 (53%)
	6-21	76 (28.6%)
	22-49	19 (7.1%)
Age Range	≥50	27 (10.2%)
	≥5b	3 (1.1%)
	Unknowna	39 (12.8%)

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 B. pertussis | 53/56a | 94.6% | 85.1-98.9% | 56/58b | 96.5% | 88.1-99.6% |
| Coronavirus 229E | 13/13 | 100% | 75.3-100% | 45/47c | 95.7% | 85.5-99.5% |
| Coronavirus OC43 | 24/24 | 100% | 85.8-100% | 33/36d | 91.7% | 77.5-98.2% |
| M. pneumoniae | 54/64e | 84.4% | 73.1-92.2% | 58/56f | 89.2% | 79.1-95.6% |

a Two (2) B. pertussis-positive specimens were originally identified by the source lab as negative for B. pertussis but were unexpectedly found to be positive by analyte specific PCR followed by bidirectional sequencing. Both of these specimens were negative when tested with the FilmArray, and both were found to be negative for B. pertussis during discrepancy investigation of confirmation testing.

b Ten (10) B. pertussis-negative specimens were originally identified by the source lab as positive for B. pertussis but this could not be confirmed by analyte specific PCR followed by bidirectional sequencing. Two (2) of these specimens were positive when tested with the FilmArray and both of these specimens were found to be positive for B. pertussis during discrepancy investigation of confirmation testing. Two (2) source laboratory positive samples were found to contain B. holmesii, both of these samples gave the expected negative result when tested with the FilmArray RP.
& One (1) CoV 229E-negative specimen was originally identified by the source lab as positive for CoV 229E but this could not be confirmed by analyte specific PCR followed by bidirectional sequencing. This specimen was positive when tested with the FilmArray RP.
4 Four (4) CoV OC43-negative specimen were originally identified by the source lab as positive for CoV OC43 but this could not be confirmed by analyte specific PCR followed by bidirectional sequencing. Two (2) of these specimens were positive when tested with the FilmArray RP.
& The Ct results obtained during confirmation PCR testing for the 10 samples that were not detected by FilmArray indicated low analyte levels in the sample (Ct range 34.3-38.7) possible resulting from sample degradation during storage of these archived specimens.
f Twenty-two (22) M. pneumoniae-negative specimens were originally identified by the source lab as positive for M. pneumoniae but this could not be confirmed by analyte specific PCR followed by bidirectional sequencing. Seven (7) of these specimens were positive when tested with the FilmArray RP.

Testing of Contrived C. pneumoniae Specimens

Archived nasopharyngeal swab specimens that have previously tested positive for C. pneumoniae were unavailable for testing. Therefore, contrived C. pneumoniae specimens were used as surrogate clinical specimens to test the sensitivity and specificity of the

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FilmArray RP C. pneumoniae assay. Residual specimens that had been collected during the prospective clinical evaluation were spiked with C. pneumoniae at clinically relevant levels (or unspiked; 50 of each). The analyte status of each contrived specimen was blinded to the users analyzing the specimens. Results of FilmArray testing are presented in Table 9. 1

Table 9. FilmArray Performance Data Summary for contrived C. pneumoniae specimens.
------------------------------------------------------------------------------------	--

	Positive Percent Agreement (PPA)				Negative Percent Agreement (NPA)
	TP/TP+FN	Percent	95% CI	TN/TN+FP	Percent	95% CI
C. pneumoniae	50/50	100%	92.9 – 100%	50/50	100%	92.9 – 100%

Selected Analytic Studies

Limit of Detection

The analytical sensitivity or Limit of Detection (LoD) for each FilmArray RP analyte was determined by testing limiting dilutions of quantified cultures of virus or bacterium. 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 concentrations for the FilmArray RP analytes CoV OC43, CoV 229E, B. pertussis, C. pneumoniae, and M. pneumoniae are listed in Table 10.

Organism	Strain	LoD Concentration
CoV OC43	ATCC VR-759	600 TCID50/mL
CoV 229E	ATCC VR-740	4 TCID50/mL
B. pertussis	A639	4000 CFU/mL
C. pneumoniae	TW183	3000 DNA copies/mL
M. pneumoniae	M129 (Type 1)	30 TCID50/mL

Table 10. LoD for Analytes Detected by FilmArray RP

NOTE: CoV OC43. CoV 229E and M. vneumoniae were grown and quantified in TCID30150% Tissue Culture Infectious Dose). The unit TCID41 is a measure of infectivity rather than number of organisms or copies of nucleic acid. Variability in TCIDs /mL may not accurately reflect differences in the relative sensitivity of detection between different organisms or different strains of the same organism.

Analytical Reactivity (Inclusivity)

The analytical reactivity of the FilmArray RP system assays was evaluated with an inclusivity panel consisting of strains or isolates that represent the genetic, temporal, and geographic diversity of the FilmArray RP analytes. The tested organisms include: 2 Coronavirus (1 229E and 1 OC43), 9 B. pertussis, 4 C. pneumoniae, and 9 M. pneumoniae. Each strain 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.

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Results from inclusivity testing of CoV OC43, CoV 229E, B. pertussis, C. pneumoniae, and M. pneumoniae are presented in Table 11. The concentration and multiple of LoD at which each strain was detected by the FilmArray RP system is indicated.

| Organism | Strain / Isolate | Concentration
Detected | Multiple of
LoD Detected |
|---------------|-------------------------------------------------|---------------------------|-----------------------------|
| CoV OC43 | ATCC VR-759 | 600 TCID50/mL | 1x |
| CoV 229E | ATCC VR-740 | 4 TCID50/mL | 1x |
| B. pertussis | A639 | 4000 CFU/mL | 1x |
| | E341 | 4000 CFU/mL. | 1x |
| | F (ATCC 8467) | 4000 CFU/mL | 1x |
| | 5 [17921] (ATCC 9340) | 4000 CFU/mL | 1x |
| | 18323 [NCTC 10739] (ATCC 9797) | 4000 CFU/mL | 1x |
| | 10-536 (ATCC 10380) | 4000 CFU/mL | 1x |
| | CNCTC Hp 12/63 [623] (ATCC 51445) | 4000 CFU/mL | 1x |
| | Tohama I (ATCC BAA-589)
(vaccine strain) | 4000 CFU/mL | 1x |
| | MN2531 (ATCC BAA-1335) | 4000 CFU/mL | 1x |
| C. pneumoniae | AR-39 (ATCC 53592) | 3000 copies/mL | 1x |
| | CDC/CWL-029 (VR-1310) | 3000 copies/mL | 1x |
| | CM-1 (ATCC VR-1360) | 3000 copies/mL | 1x |
| | TW183 (ATCC VR-2282) | 3000 copies/mL | 1x |
| M. pneumoniae | M129 (Type 1) | 30 TCID50/mL | 1x |
| | M129-B7 (ATCC 29342) (Type 1) | 300 CCU/mL a | 10x b |
| | PI 1428 (ATCC 29085) (Type 1) | 3,000 CCU/mL a | 100x b |
| | FH strain [NCTC 10119] (ATCC 15531)
(Type 2) | 300 CFU/mL c | n/a c |
| | [Mac] (ATCC 15492) (Type 2) | 300 CCU/mL a | 10x b |
| | [M52] (ATCC 15293) | 300 CCU/mL a | 10x b |
| | [Bru] (ATCC 15377) | 30,000 CCU/mL a | 1,000x b |
| | Mutant 22 (ATCC 39505) | 30 CCU/mL a | 1x b |
| | UMTB-10G (ATCC 49894) | 300 CCU/mL a | 10x b |

		Table 11. Results of Inclusivity Testing
--	--	------------------------------------------

4 CCU = Color Changing Unit. Both TCIDs, and CCU were determined according to the Reed-Muench method. Quantification in CCU/mL was considered equivalent to quantification in TCID46 mL.

6 Following inclusivity testing, all M. pneumoniae isolates previously quantified in CCU/ml. were re-evaluated by realtime PCR against a standard curve of the LoD strain (M129, TCID-6/mL). Based on relative molecular quantification, all isolates were detected at levels Staphylococcus aureus | $1.0 \times 10^6$ CFU/mL |
| 20 ng/µL | Neisseria meningitidis | $1.0 \times 10^6$ CFU/mL |
| | Corynebacterium diptheriae | $1.0 \times 10^6$ 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) | FluMist® Nasal Influenza Vaccine (2009-2010) | |

Table 20. List of Potentially Interfering Substances Evaluated

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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

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21

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/21/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring a symbol that resembles a caduceus or a staff with a snake winding around it.

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

Idaho Technology Inc. c/o Beth Lingenfelter 390 Wakara Way Salt Lake City, UT 84108

AAY 1 5 2012

Re: K120267

Trade/Device Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Dated: Received:

FilmArray Respiratory Panel (RP) 21 CFR 866.3980 Respiratory Viral Panel Multiplex Nucleic Acid Assav Class II OCC, OEM, OOU, OEP, OTG, NXD, OOI, OZZ, OZY, OZX April 3, 2012 April 5, 2012

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

22

Page 2 – Beth Lingenfelter

will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,

Uwe Schuf 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

23

Indications for Use

510(k) Number: K120267

Device Name: FilmArray Respiratory Panel (RP)

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 and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the FilmArrav RP: Adenovirus, Coronavirus 229E. Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus. Influenza A. Influenza A subtype H1. Influenza A subtype H3. Influenza A subtype 2009 H1, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamvdophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the Film Array RP may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis, Coronavirus 229E, Coronavirus OC43, Influenza A/H1, Influenza A/H3, Influenza A/2009 H1, Influenza B. Mycoplasma pneumoniae Parainfluenza Virus 1, Parainfluenza Virus 2, and Parainfluenza Virus 4 were established primarily with retrospective clinical specimens. Performance characteristics for Chlamydophila pneumoniae were established primarily using contrived clinical specimens.

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 2 and 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).

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The FilmArray RP assay for Coronavirus OC43 may cross-react with some isolates of Coronavirus HKU1. A dual positive result may be due to cross-reactivity or may indicate a co-infection.

Performance characteristics for influenza A were established when influenza A/2009 HIN1, A/H1, and A/H3 were the predominant influenza A viruses in circulation. Performance of detecting influenza A may vary if other influenza A strains are circulating or a novel influenza A virus emerges. 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.

Prescription Use X (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 Device Evaluation (ODE) Jamor g Tillellal

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(K) K120267