FilmArray Respiratory Panel EZ (RP EZ)

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K152579 B. Purpose for Submission: New device 510k clearance for the FilmArray® Respiratory Panel EZ (RP EZ). C. Measurand: Adenovirus, Bordetella pertussis, Chlamydophila pneumoniae, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Coronavirus 229E, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, Influenza B, Mycoplasma pneumoniae, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, and Respiratory Syncytial Virus nucleic acid target sequences in nasopharyngeal swabs. D. Type of Test: A multiplexed nucleic acid test intended for the qualitative in vitro detection and identification of multiple respiratory pathogen nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray® Respiratory Panel EZ (RP EZ) G. Regulatory Information: 1. Regulation section: 21 CFR section 866.3980, Respiratory Viral Panel Multiplex Nucleic Acid Assay 2. Classification: Class II {1} 3. Product code(s): OCC, OEM, OOU, OEP, OTG, OOI, OZX, OQW, OZY, OZZ, 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): FilmArray Respiratory Panel EZ (RP EZ) is a multiplexed nucleic acid test intended for use with the FilmArray 2.0 EZ Configuration 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 EZ: Adenovirus, Coronavirus, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B, Parainfluenza Virus, Human Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or, lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the FilmArray RP EZ 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, Influenza A H1, Influenza A H3, Influenza A H1-2009, Influenza B, Mycoplasma pneumoniae, and Parainfluenza Virus 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 EZ cannot reliably differentiate them. A positive FilmArray RP EZ Rhinovirus/Enterovirus result should be followed-up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. 2 {2} Performance characteristics for Influenza A were established when Influenza A H1-2009, 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. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: FilmArray 2.0 EZ Configuration instrument I. Device Description: The FilmArray Respiratory Panel EZ (RP EZ) consists of two basic components: the FilmArray RP EZ pouch and the FilmArray 2.0 EZ Configuration instrument. The description of this device is essentially the same as that of the FDA-cleared FilmArray Respiratory Panel (RP), except for the software modifications and the control reagent modifications described below. Please refer to FDA cleared 510(k) submissions k103175, k110764, k120267, k123620, and k143080 for detailed device descriptions. Software Modifications: 1. Implemented a simplified EZ version of the software running on FilmArray 2.0 EZ Configuration instrument. This version includes updates/changes to the workflow, error handling, run browsing, instrument control, database management, notes and tags dialogue, report content, and software architecture. For example, this version removes the ability to use more than one FilmArray 2.0 instrument from a single connected laptop computer, the availability of the "FilmArray Dashboard", and user access to the "PCR Evaluator". 2. Introduced a new FilmArray RP EZ pouch module, which modified the test results from reporting the four Coronavirus types (i.e., Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, and Coronavirus OC43) and the four Parainfluenza virus types (i.e., Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, and Parainfluenza Virus 4) separately and independently to reporting a single 'combined' Coronavirus result and a single 'combined' Parainfluenza virus. {3} Control Reagent Modification: A new external control panel that is available from Maine Molecular Quality Controls, Inc., Scarborough, ME (online at www.mmqci.com) was recommended for use with the FilmArray RP EZ. This external control panel consists of a set of ready-to-use positive and negative control solutions, along with a package insert explaining the expected results. This external control panel should be tested when receiving a new shipment of test pouches and when training a new user. # J. Substantial Equivalence Information: 1. Predicate device name(s): FilmArray Respiratory Panel (RP) (for use with the FilmArray 2.0 and FilmArray Injection Vials) 2. Predicate 510(k) number: K143080 3. Comparison with predicate: | Similarities and Differences | | | | --- | --- | --- | | Item | Device | Predicate | | | FilmArray Respiratory Panel EZ (RP EZ) (K152579) | FilmArray Respiratory Panel (RP) (K143080) | | Organisms Reported | Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, Influenza B, Respiratory Syncytial Virus, Human Metapneumovirus, Adenovirus, Parainfluenza, Human Rhinovirus/Enterovirus, Coronavirus, Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Bordetella pertussis | 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, Human Rhinovirus/Enterovirus, Coronavirus HKU1, Coronavirus NL63, Coronavirus 229E, Coronavirus OC43, Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Bordetella pertussis. | | Analyte | RNA/DNA | Same | | Specimen Type | Nasopharyngeal swab | Same | | Technological Principles | Nested multiplex RT-PCR followed by high resolution melting analysis to confirm identity of amplified product. | Same | | Instrumentation | FilmArray 2.0 EZ Configuration | FilmArray or FilmArray 2.0 | | Time to Result | About 1 hour | Same | {4} | Similarities and Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Test Interpretation | FilmArray Respiratory Panel EZ (RP EZ) (K152579) | FilmArray Respiratory Panel (RP) (K143080) | | | Automated test interpretation and report generation | Same | | User Access to Raw Data | User cannot access raw data (melt analysis data and individual assay results) | User can access raw data (melt analysis data and individual assay results) | | Reagent Hydration and Sample Loading | FilmArray Injection Vial-based loading procedure. | Same | | Sample Preparation Method | Sample Processing is automated in the FilmArray RP pouch | Same | | Reagent Storage | Reagents are stored at room temperature | Same | | On-board Controls | Two controls are included in each reagent pouch to control for sample processing and both stages of PCR and melt analysis | Same | | External Controls | External control panel that is available from Maine Molecular Quality Controls, Inc. (online at www.mmqci.com) | Use viral transport medium as the external negative control, and previously characterized positive samples or negative samples spiked with well characterized organisms as external positive controls | | User Complexity | Low | Moderate | K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The FilmArray RP EZ is multiplex nucleic acid test system composed of the FilmArray RP EZ pouch and the FilmArray 2.0 EZ Configuration instrument. The FilmArray RP EZ pouch contains freeze-dried reagents to perform nucleic acid purification, reverse transcription, and nested multiplex PCR with DNA melt analysis. Please refer to previously FDA-cleared 510(k) Premarket Notifications k103175, k110764, k120267, k123620, and k143080 for additional information. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: {5} There are no changes to the reagent pouch. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for precision/reproducibility performance information. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): ## Controls External Positive and Negative Controls A new external control panel that is available from Maine Molecular Quality Controls, Inc., Scarborough, ME (online at www.mmqci.com) is recommended to be used with the FilmArray RP EZ: FilmArray RP EZ Control Panel M265, Part number M265 - RP EZ Positive M266, Part number M266 - RP EZ Negative M267, Part number M267 This external control panel is also available as BioFire Diagnostics Part Number CHEM-CTL-0001. The external control panel consists of a set of ready-to-use positive and negative control solutions, along with a package insert explaining the expected results. The external control panel should be tested when receiving a new shipment of test pouches and when training a new user. This external control panel is the subject of separate 510(k) Premarket Notification K161573 from Maine Molecular Quality Controls, Inc., Scarborough, ME. A field study was performed to assess the ability of the intended user to perform external control testing using the recommended control materials and testing procedure for the FilmArray Respiratory Panel EZ (RP EZ) in a CLIA-waived setting. The primary metric evaluated by this study was the ability of these users to acquire and accurately interpret FilmArray RP EZ results when testing the provided external control materials. The FilmArray RP EZ test was performed according to the manufacturer's instructions by users with training and educational backgrounds consistent with those in the CLIA-waived testing environment (i.e., the intended users). User training on use of the FilmArray RP EZ was limited to the training video and the quick guide provided with the FilmArray RP EZ system. The external control panel tested in this study consisted of a positive mix containing synthetic targets for all FilmArray RP EZ analytes and a negative mix that contains no analytes. Multiple operators participated in this study at each of the three sites (a total of 16 different FilmArray RP EZ operators across the three sites). Testing 6 {6} consisted of three positive and three negative controls run per day, and spanned a period of 10 days (total of 60 control runs per site). Three lots each of the external control panel and three lots of FilmArray RP EZ pouches were tested across all sites. A total of 182 external controls were tested (91 positive and 91 negative) by FilmArray RP EZ users at two CLIA-waived clinical settings and one simulated testing setting (BioFire Diagnostics). Two test runs were excluded from final data analysis due to invalid results caused by internal pouch control failures. Data for the remaining 180 control tests are shown below in Table 1. Table 1. Summary of FilmArray RP EZ External Controls Testing Results | Site | Positive | Negative | Total | | --- | --- | --- | --- | | #1 | 30/30 (100%) | 28/30 (93.3%) | 58/60 (96.7%) | | #2 | 30/30 (100%) | 30/30 (100%) | 60/60 (100%) | | #3 | 30/30 (100%) | 30/30 (100%) | 60/60 (100%) | | Total | 90/90 (100%) | 88/90 (97.8%) | 178/180 (98.9%) | The control material testing in this study produced an unexpected result in two test runs. In both cases, expected negative control mixes produced Coronavirus detections. Retrospective analysis of the two instances did not lead to any correlation between the two events, other than the fact that both of these tests were performed at the same site. The day of testing, operator, instrument, pouch lot, control mix lot, and species of Coronavirus detected (i.e., NL63 vs 229E) were all different. After examining the workflow, the timeline of events and the details of the runs, the most likely cause of both instances is determined to be due to carryover from a positive control that was loaded within close time proximity to the negative control. It is possible that the users disregarded the instructions to only handle one sample and pouch at a time. As a way of introducing further mitigation measures to guard against potential carry-over contamination from the positive control material, additional warnings and guidelines (e.g., "the negative control test should be run before the positive control test" and "change gloves and clean the work area between preparation of each sample", etc.) have been added to the product labeling and the training video. Overall, these data demonstrate that the intended user can accurately perform external control testing using the FilmArray RP EZ in a CLIA-waived setting. # d. Detection Limit: The FilmArray RP EZ pouch is exactly the same as the FilmArray RP pouch. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for Limit of Detection performance. {7} e. Analytical Reactivity: The FilmArray RP EZ pouch is exactly the same as the FilmArray RP pouch. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for Analytical Reactivity performance. No additional testing was conducted. f. Analytical Specificity: The FilmArray RP EZ pouch is exactly the same as the FilmArray RP pouch. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for Analytical Specificity performance. No additional testing was conducted. g. Potentially Interfering Substances: The FilmArray RP EZ pouch is exactly the same as the FilmArray RP pouch. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for Potentially Interfering Substances study information and results. No additional testing was conducted. h. Potential Microbial Interference Study: The FilmArray RP EZ pouch is exactly the same as the FilmArray RP pouch. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for Potential Microbial Interference study information and results. No additional testing was conducted. i. Carry-Over Study: The FilmArray RP EZ pouch is exactly the same as the FilmArray RP pouch, and the workflow for the FilmArray RP EZ is also the same as that of the FilmArray RP. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for Carry-over study information and results. No additional testing was conducted. j. Assay cut-off: The FilmArray RP EZ assay cut-offs are exactly the same as the FilmArray RP assay cut-offs. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for assay cut-off information. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. {8} b. Matrix comparison: Not applicable. # 3. Clinical Studies: The FilmArray RP EZ pouch is exactly the same as the FilmArray RP pouch, and the workflow for the FilmArray RP EZ is also the same as that of the FilmArray RP. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for clinical studies information and results. # 4. Clinical cut-off: Not applicable. # 5. Expected values: The FilmArray RP EZ pouch is exactly the same as the FilmArray RP pouch, and the workflow for the FilmArray RP EZ is also the same as that of the FilmArray RP. Please refer to previously FDA-cleared 510(k) Premarket Notifications, k103175, k110764, k120267, k123620, and k143080 for expected values of the FilmArray RP. In addition, the number and percentage of positive cases, as well as co-detections, as determined by FilmArray RP EZ at five geographically distinct US locations during the 2014/2015 respiratory season (November 2014 – July 2015) calculated by age group are presented in the following tables: Table 2. Expected Value (as Determined by FilmArray RP EZ) Summary by Age Group (November 2014 – July 2015) | Organism | Overall (n=1049) | | ≤ 5 (n=353) | | 6-21 (n=176) | | 22-49 (n=364) | | 50+ (n=156) | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | #* | EV** | #* | EV** | #* | EV** | #* | EV** | #* | EV** | | Adenovirus | 26 | 2.5% | 22 | 6.2% | 3 | 1.7% | 1 | 0.3% | 0 | 0% | | Coronavirus | 65 | 6.2% | 28 | 7.9% | 7 | 4.0% | 21 | 5.8% | 9 | 5.8% | | Human Metapneumovirus | 56 | 5.3% | 39 | 11.0% | 9 | 5.1% | 7 | 1.9% | 1 | 0.6% | | Human Rhinovirus/Enterovirus | 240 | 22.9% | 110 | 31.2% | 40 | 22.7% | 70 | 19.2% | 20 | 12.8% | | Influenza A (total) | 38 | 3.6% | 10 | 2.8% | 16 | 9.1% | 8 | 2.2% | 4 | 2.6% | | Influenza A H1 | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% | | Influenza A H1-2009 | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% | | Influenza A H3 | 38 | 3.6% | 10 | 2.8% | 16 | 9.1% | 8 | 2.2% | 4 | 2.6% | | Influenza B | 26 | 2.5% | 5 | 1.4% | 8 | 4.5% | 5 | 1.4% | 8 | 5.1% | | Parainfluenza Virus | 87 | 8.3% | 55 | 15.6% | 8 | 4.5% | 14 | 3.8% | 10 | 6.4% | | Respiratory Syncytial Virus | 78 | 7.4% | 49 | 13.9% | 13 | 7.4% | 10 | 2.7% | 6 | 3.8% | | Bordetella pertussis | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% | | Chlamydophila pneumoniae | 2 | 0.2% | 1 | 0.3% | 1 | 0.6% | 0 | 0% | 0 | 0% | {9} Table 3. Co-Detections (as Determined by FilmArray RP EZ) Summary by Age Group (November 2014 – July 2015) | Co-Detection *** | Overall (n=1049) | | ≤ 5 (n=353) | | 6-21 (n=176) | | 22-49 (n=364) | | 50+ (n=156) | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | #* | EV** | #* | EV** | #* | EV** | #* | EV** | #* | EV** | | HRV/EV + PIV | 12 | 1.1% | 9 | 2.5% | 1 | 0.6% | 0 | 0% | 2 | 1.3% | | hMPV + HRV/EV | 6 | 0.6% | 5 | 1.4% | 1 | 0.6% | 0 | 0% | 0 | 0% | | Adenovirus + HRV/EV | 5 | 0.5% | 4 | 1.1% | 1 | 0.6% | 0 | 0% | 0 | 0% | | CoV + HRV/EV | 5 | 0.5% | 2 | 0.6% | 1 | 0.6% | 2 | 0.5% | 0 | 0% | | CoV + RSV | 4 | 0.4% | 3 | 0.8% | 0 | 0% | 0 | 0% | 1 | 0.6% | | HRV/EV + RSV | 4 | 0.4% | 3 | 0.8% | 0 | 0% | 1 | 0.3% | 0 | 0% | | Adenovirus + PIV | 3 | 0.3% | 3 | 0.8% | 0 | 0% | 0 | 0% | 0 | 0% | | Adenovirus + CoV | 2 | 0.2% | 2 | 0.6% | 0 | 0% | 0 | 0% | 0 | 0% | | hMPV + PIV | 2 | 0.2% | 2 | 0.6% | 0 | 0% | 0 | 0% | 0 | 0% | | Adenovirus + hMPV + HRV/EV | 1 | 0.1% | 1 | 0.3% | 0 | 0% | 0 | 0% | 0 | 0% | | Adenovirus + hMPV | 1 | 0.1% | 1 | 0.3% | 0 | 0% | 0 | 0% | 0 | 0% | | CoV + hMPV + HRV/EV | 1 | 0.1% | 1 | 0.3% | 0 | 0% | 0 | 0% | 0 | 0% | | CoV + HRV/EV + RSV | 1 | 0.1% | 1 | 0.3% | 0 | 0% | 0 | 0% | 0 | 0% | | CoV + Influenza A H3 | 1 | 0.1% | 0 | 0% | 1 | 0.6% | 0 | 0% | 0 | 0% | | CoV + PIV | 1 | 0.1% | 1 | 0.3% | 0 | 0% | 0 | 0% | 0 | 0% | | HRV/EV + Influenza A H3 | 1 | 0.1% | 1 | 0.3% | 0 | 0% | 0 | 0% | 0 | 0% | | HRV/EV + Influenza B | 1 | 0.1% | 0 | 0% | 0 | 0% | 0 | 0% | 1 | 0.6% | | Influenza A H3 + RSV | 1 | 0.1% | 0 | 0% | 1 | 0.6% | 0 | 0% | 0 | 0% | | PIV + M. pneumoniae | 1 | 0.1% | 1 | 0.3% | 0 | 0% | 0 | 0% | 0 | 0% | | PIV + RSV | 1 | 0.1% | 0 | 0% | 0 | 0% | 1 | 0.3% | 0 | 0% | * # = number of prospective specimens ** EV = expected value as determined by FilmArray RP EZ *** CoV = Coronavirus; hMPV = human Metapneumovirus; HRV/EV = human Rhinovirus/Enterovirus; PIV = Parainfluenza Virus; RSV = Respiratory Syncytial Virus # N. Instrument Name: FilmArray 2.0 EZ Configuration {10} O. System Descriptions: 1. Modes of Operation: See Section, I. Device Description 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ X or No ☐ a. Level of Concern: The Level of Concern was established as moderate during the initial clearance for the FilmArray RP under k103175. The level has not changed. b. Software Description: The software description was updated. The changes from the last cleared version of the software include updates to the workflow, error handling, run browsing, instrument control, database management, notes and tags dialogue, report content, software architecture, introduction of the EZ pouch module (along with associated documentation), the combination of coronavirus assays into a single call and the combination of parainfluenza virus assays into single call for the CLIA-waived pouch module. The FilmArray EZ Pouch Module, as defined in the software, contains all the information that is needed to analyze and interpret the data from a FilmArray 2.0 instrument run. The fundamental elements of the pouch definition are the assays, array layout, controls, and interpretations. Of note, the FilmArray RP EZ software removes the ability to use more than one instrument, removes the availability of the “Dashboard” and removes access to the “PCR Evaluator”. The FilmArray RP EZ software is controlled by Windows-based software running on a laptop that is connected to one FilmArray 2.0 Instrument. The software has been designed to be simple to ensure that tests are correctly performed and test results are not misinterpreted. The descriptions provided appear to be acceptable. c. Device Hazard Analysis (DHA): The DHA was updated to reflect the risks of both Off-The-Shelf and FilmArray software in the context of the FilmArray RP EZ system. A tabular list of potential hazards and an assessment of risk posed by the software and any interactive components was provided. Risks were calculated and categorized as High, Medium, Low or Zero. Risks were deemed acceptable after appropriate mitigations were put in place to address each risk. 11 {11} d. Software Design Specification (SDS): SDS documentation was referenced and referenced accordingly. During software and firmware development, detailed development documents were produced under the Quality System. The design specifications drove the software and firmware development, dictated the behavior of the modules, and formed the basis of design verification. The documentation provided appears to be acceptable. e. Software Requirements Specifications (SRS): Updates were provided to the SRS documentation, produced under the Quality System. The SRS includes a summary list of the fundamental hardware and software components necessary to functionally implement the software changes for the FilmArray RP EZ. The submitted documentation appears to be acceptable. f. Traceability: Updates were provided to the trace matrix from design input to output, providing information showing traceability for hardware and software requirements, risk assessment, and validation, as applicable. The submitted traceability appears to be acceptable. g. Verification and Validation (V&V): Updates were provided to the V&V documentation. This information included a detailed description of validation activities, test protocol, pass/fail criteria and results of those activities. These V&V activities were tied through a trace matrix to system requirements and a risk assessment, where appropriate. These activities included verification that features that were originally available to the end user remained available and functional after the modifications were made. The submitted documentation appears to be acceptable. h. Revision Level History (RLH): An update was provided to the RLH. The latest version of the FilmArray RP EZ software is v2.100.16. The latest version removes the ability to use more than one instrument, and removes availability of the "Dashboard" and access to the "PCR Evaluator". The submitted RLH appears to be acceptable. i. Architecture Design Chart: An update was provided to the Architecture Design Chart including diagrams and charts describing workflow, general structure, available utilities and assay and instrumentation control/management from beginning of an assay run to data analysis to result output. This appears to be acceptable. j. Unresolved Anomalies (UA): An update was provided to the Unresolved Anomalies. One unresolved anomaly was identified that can have a minimal impact on the pre-production process, but cannot impact the released version of the software for the FilmArray RP EZ. Therefore, the statement and documentation appear to be acceptable. 12 {12} k. Instrument User Manual: BioFire Diagnostics, LLC provided a copy of the FilmArray 2.0 EZ Configuration Operators Manual. The submitted instrumentation labeling appears to be acceptable. 3. Specimen Identification: User enters Patient ID/Sample ID by typing it in. 4. Specimen Sampling and Handling: Not Applicable 5. Calibration: Not required. 6. Quality Control: Quality control is addressed for each specific FDA-cleared assay to be run on the instrument (separately cleared). P. Other Supportive Instrument Performance Characteristics Data Not Covered In the "Performance Characteristics" Section above: Not applicable. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 13