The BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini) is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® SPOTFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.

The following organism types and subtypes are identified and differentiated using the SPOTFIRE R Panel Mini:

Coronavirus SARS-CoV-2
· Human rhinovirus
· Influenza A virus
· Influenza B virus
· Respiratory syncytial virus

Nucleic acids from the viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. The detection of specific viral nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection are indicative of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient 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 may not be detected by an NPS specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by the SPOTFIRE R Panel Mini 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.

Device Description

The BIOFIRE SPOTFIRE Respiratory (R) Panel Mini simultaneously identifies five different respiratory viral pathogens in nasopharyngeal swabs (NPS) from individuals with signs and symptoms of respiratory tract infection (see Table 1). The SPOTFIRE R Panel Mini is compatible with the BIOFIRE® System, a polymerase chain reaction (PCR)-based in vitro diagnostic system for infectious disease testing. The BIOFIRE System Software executes the SPOTFIRE R Panel Mini test and interprets and reports the test results.

A test is initiated by loading Hydration into one port of the SPOTFIRE R Panel Mini pouch and NPS specimen mixed with the provided Sample Buffer into the other port of the SPOTFIRE R Panel Mini pouch and placing it in the SPOTFIRE System. The pouch contains all of the reagents required for speciment 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 SPOTFIRE System Software quides the user through the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

The SPOTFIRE System contains coordinated systems 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 liguid 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 multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier and cooling of the pouch to drive the PCR reactions and the melt curve analysis.

Nucleic acid extraction occurs within the SPOTFIRE R Panel Mini pouch using mechanical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the SPOTFIRE System performs a nested multiplex PCR that is executed in two stage, the SPOTFIRE System 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 doublestranded DNA binding dye (LC Green® Plus, BioFire Diagnostics). The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 2nd stage PCR, or nested PCR, is performed in singleplex fashion in each well of the array. At the conclusion of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.

The SPOTFIRE System Software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.

AI/ML Overview

The provided text describes the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini, a PCR test for detecting respiratory viral nucleic acids. However, the document, being a Special 510(k) Summary, focuses on demonstrating substantial equivalence to a predicate device (BIOFIRE® SPOTFIRE® Respiratory (R) Panel) rather than providing detailed, de novo performance study results against specific acceptance criteria.

The key statement regarding performance data is:
"The performance data for the SPOTFIRE R Panel Mini is identical to the SPOTFIRE R Panel (K213954), but only contains data for the five analytes detected by the SPOTFIRE R Panel Mini (Coronavirus SARS-CoV-2, human rhinovirus, influenza A virus, influenza B virus, and respiratory syncytial virus). Please see the BIOFIRE Respiratory Panel Mini Instructions for Use for performance tables."

This indicates that the performance of the Mini Panel relies on the studies conducted for the full Panel. To fully answer your request, the "BIOFIRE Respiratory Panel Mini Instructions for Use" would be needed, as that is where the detailed performance tables (which would contain acceptance criteria and reported performance) are referenced.

Based on the provided text, here's what can be extracted and what cannot be:

Since the document directly states that the performance data for the Mini Panel is identical to the full Panel for the relevant analytes, and directs to the Instructions for Use for details, it implies that no new, separate, full-scale clinical study was conducted for the Mini Panel. Instead, the justification for meeting acceptance criteria is based on the performance of the predicate device.

Extracted Information from the Provided Document:

1. A table of acceptance criteria and the reported device performance:

Cannot be fully provided from this document. The document states: "Please see the BIOFIRE Respiratory Panel Mini Instructions for Use for performance tables." This means the specific acceptance criteria and reported performance values (like sensitivity, specificity, accuracy) are not contained within this 510(k) summary directly.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Cannot be fully provided from this document. This information would be detailed in the performance study section of the predicate device's submission or its Instructions for Use, which is not included here. The document only states that the performance data for the Mini Panel is "identical" to the predicate for the five analytes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable / Cannot be provided. This device is an in vitro diagnostic (IVD) PCR test, not an imaging AI device. Ground truth for IVD tests is typically established through reference methods (e.g., highly sensitive PCR assays, culture, sequencing) on clinical samples, not by expert readers or adjudicators in the way it's done for medical imaging. The concept of "experts" as in radiologists is thus not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As stated above, this is an IVD PCR device. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation studies where human experts disagree. For PCR tests, discordance resolution might occur by running a different highly sensitive reference method, but it's not "adjudication" in the sense used for human image interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is an in vitro diagnostic (IVD) PCR test, not an AI medical imaging device that assists human readers. There are no "human readers" interpreting images to be assisted by this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, for the predicate device. The BIOFIRE SPOTFIRE system, including this Mini Panel, functions as a standalone diagnostic test providing a qualitative result (positive/negative for each pathogen). Its performance (sensitivity, specificity, accuracy) is inherently assessed in a standalone manner, separate from human interpretation of the raw PCR data/results. The "algorithm" here is the system's software that interprets the PCR melt curve analysis and internal controls to provide a final diagnostic result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Reference molecular methods / clinical diagnosis. For IVD PCR tests, ground truth for clinical samples is typically established by comparing the device's results to a highly sensitive and specific reference molecular method (e.g., another FDA-cleared or laboratory-developed PCR assay, often employing bi-directional sequencing for confirmation) applied to the same or split clinical samples. This is implicitly what happens for the predicate device's performance studies. The overall diagnosis for a patient would then integrate this with other clinical and epidemiological information. Clinical outcomes data or pathology are not typically the primary ground truth for direct pathogen detection performance of a PCR test.

8. The sample size for the training set:

Not explicitly stated in this document. For IVD PCR devices, the "training set" doesn't strictly apply in the sense of machine learning model training on large datasets. Instead, it refers to samples used during the development and optimization phases of the assay. This information is confidential and not typically disclosed in a 510(k) summary. The focus for this submission is on demonstrating that the modified software for the Mini Panel (which just filters results from the existing R Panel) has been "verified and validated to show no change in safety and effectiveness," implying no new large-scale training was needed.

9. How the ground truth for the training set was established:

Not explicitly stated/applicable in the ML sense. As above, "training set" for PCR development involves using characterized samples (e.g., spiked samples, clinical samples with known positivity/negativity determined by reference methods) to optimize assay parameters. The exact methodology would be part of the intellectual property of the manufacturer and documented internally.

Summary of Acceptance Criteria and Study Proof (as much as inferred from the document):

Given the nature of this submission as a "Special 510(k)," the core proof for the device meeting acceptance criteria is its substantial equivalence to the predicate BIOFIRE® SPOTFIRE® Respiratory (R) Panel (K213954). The acceptance criteria for the Mini Panel are, by this logic, implicitly met if the performance for the shared analytes (Coronavirus SARS-CoV-2, human rhinovirus, influenza A virus, influenza B virus, and respiratory syncytial virus) is identical to the already cleared predicate device.

The study that proves the device meets the acceptance criteria is effectively the original clinical performance study conducted for the predicate BIOFIRE® SPOTFIRE® Respiratory (R) Panel (K213954).
The specific data, including sensitivity, specificity, positive predictive value, and negative predictive value, along with the sample types and sizes from those studies, would be found in the Indications for Use or similar performance summary section of the K213954 submission or its final labeling.

The current document confirms that:

The Mini Panel is an identical product to the full Panel, with modified labeling and software to report only five of the 15 analytes.
The modified software has been "verified and validated to show no change in safety and effectiveness."
"The performance data for the SPOTFIRE R Panel Mini is identical to the SPOTFIRE R Panel (K213954), but only contains data for the five analytes detected by the SPOTFIRE R Panel Mini."

Therefore, the proof that the device meets acceptance criteria relies entirely on the previously conducted studies for the predicate device, which presumably demonstrated acceptable clinical performance for those five analytes.

Summary

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April 13, 2023

Biofire Diagnostics, LLC Kevin Bourzac Vice President, Regulatory and Clinical Affairs 515 Colorow Drive Salt Lake City, Utah 84108

Re: K230719

Trade/Device Name: BIOFIRE SPOTFIRE Respiratory (R) Panel Mini Regulation Number: 21 CFR 866.3981 Regulation Name: Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The SARS-Cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-Target Test Regulatory Class: Class II Product Code: QOF, OCC, OTG, OZE Dated: March 15, 2023 Received: March 15, 2023

Dear Kevin Bourzac:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Joseph Briggs -S

Joseph Briggs, Ph.D. Deputy Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230719

Device Name BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

Indications for Use (Describe)

The following organism types and subtypes are identified and differentiated using the SPOTFIRE R Panel Mini:

Coronavirus SARS-CoV-2
· Human rhinovirus
· Influenza A virus
· Influenza B virus
· Respiratory syncytial virus

Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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BIOFIRE® SPOTFIRE® Respiratory Panel Mini

Special 510(k) Summary BioFire Diagnostics, LLC

Introduction:

The purpose of this Special 510(k) submission is to obtain clearance for the BIOFIRE SPOTFIRE Respiratory (R) Panel Mini.

The SPOTFIRE R Panel Mini is an identical product to the BIOFIRE SPOTFIRE Respiratory (R) Panel (K213954) that uses modified labeling and modified software to report five of the 15 analytes available on the SPOTFIRE R Panel (see Table 1).

Additionally, the modified software collapses the result of Influenza A into a single call (reported as Influenza A Subtype H3 or Influenza A Subtype H1-2009 on the SPOTFIRE R Panel).

Modifications to the BIOFIRE R Panel labeling, which includes changes to the Instructions for Use and Quick Guide, have been made to reflect the change in panel name and reported analytes.

According to the requirements of 21 CFR 807.92, the information included with this submission provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitted by:

BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108

Contact: Kevin Bourzac. Ph.D. Telephone: 801-736-6354. ext. 1358 Fax: 801-588-0507 Email: Kevin.Bourzac@biomerieux.com

Date submitted: March 15, 2023

Device Name and Classification:

Trade name: BIOFIRE® SPOTFIRE® Respiratory Panel Mini

Regulation Number: 21 CFR 866.3981

Classification Name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Predicate Device:

K213954 – BIOFIRE® SPOTFIRE® Respiratory (R) Panel

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini Special 510(k)

March 15, 2023 BioFire Diagnostics, LLC

Page 1 510(k) Summary

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Intended Use:

The following organism types and subtypes are identified and differentiated using the SPOTFIRE R Panel Mini:

Coronavirus SARS-CoV-2 ●
Human rhinovirus
Influenza A virus
. Influenza B virus
Respiratory syncytial virus

Nucleic acids from the viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection are indicative of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

Device Description:

Image /page/5/Figure/13 description: The image shows the title of a table. The title is "Table 1. Analytes Detected by the SPOTFIRE R Panel Mini". The title is written in a clear, legible font.

Viruses
Coronavirus SARS-CoV-2
Human rhinovirus
Influenza A virus
Influenza B virus
Respiratory syncytial Virus

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini Special 510(k)

March 15, 2023 BioFire Diagnostics, LLC

Page 2 510(k) Summary

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to open or close a channel. In addition, electronically-controlled pneumatic pistons are multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier and cooling of the pouch to drive the PCR reactions and the melt curve analysis.

Substantial Equivalence:

The SPOTFIRE R Panel Mini is substantially equivalent to the SPOTFIRE R Panel (K213954), which was cleared on February 03, 2023, and determined to be a Class II device under the classification code 21 CFR 866.3981.

A table comparing the SPOTFIRE R Panel Mini to the SPOTFIRE R Panel is provided in Table 2.

Element	Predicate: SPOTFIRE R Panel (K213954)	New Device: SPOTFIRE R Panel Mini
	The BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE R Panel) is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® SPOTFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.	The BIOFIRE® SPOTFIRE® Respiratory ® Panel Mini (SPOTFIRE R Panel Mini) is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® SPOTFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.
Intended Use	The following organism types and subtypes are identified and differentiated using the SPOTFIRE R Panel:	The following organism types are identified and differentiated using the SPOTFIRE R Panel Mini:
	VirusesAdenovirus	• Coronavirus SARS-CoV-2
	Coronavirus (seasonal)	• Human rhinovirus
	Coronavirus SARS-CoV-2	• Influenza A virus
	Human metapneumovirus	• Influenza B virus
	Human rhinovirus/enterovirus	• Respiratory syncytial virus
	Influenza A virus	Nucleic acids from the viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection are indicative of the presence of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
	Influenza A virus A/H1-2009
	Influenza A virus A/H3
	Influenza B virus
	Parainfluenza virusRespiratory syncytial virus
	Bacteria
	Bordetella parapertussis
	Bordetella pertussis
	Chlamydia pneumoniaeMycoplasma pneumoniae	Negative results in the setting of a respiratory illness may be due to infection with pathogens
	Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. The detection and
BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniSpecial 510(k)	March 15, 2023BioFire Diagnostics, LLC	Page 3510(k) Summary
identification of specific viral and bacterial nucleicacids from individuals exhibiting signs and/orsymptoms of respiratory infection are indicative ofthe presence of the identified microorganism andaids in diagnosis if used in conjunction with otherclinical and epidemiological information, andlaboratory findings. The results of this test shouldnot be used as the sole basis for diagnosis,treatment, or other patient managementdecisions.Negative results in the setting of a respiratoryillness may be due to infection with pathogensthat are not detected by this test, or lowerrespiratory tract infection that may not bedetected by an NPS specimen. Positive resultsdo not rule out coinfection with other organisms.The agent(s) detected by the SPOTFIRE R Panelmay not be the definite cause of disease.Additional laboratory testing (e.g., bacterial andviral culture, immunofluorescence, andradiography) may be necessary when evaluatinga patient with possible respiratory tract infection.	that are not detected by this test, or lowerrespiratory tract infection that may not bedetected by an NPS specimen. Positive results donot rule out coinfection with other organisms. Theagent(s) detected by the SPOTFIRE R Panel Minimay not be the definite cause of disease.Additional laboratory testing (e.g., bacterial andviral culture, immunofluorescence, andradiography) may be necessary when evaluatinga patient with possible respiratory tract infection.
Specimen Types	Nasopharyngeal swab in transport media	Same
Organisms detected	VirusesAdenovirusCoronavirus (seasonal)Coronavirus SARS-CoV-2Human metapneumovirusHuman rhinovirus/enterovirusInfluenza A virusInfluenza A virus A/H1-2009Influenza A virus A/H3Influenza B virusParainfluenza virusRespiratory syncytial virusBacteriaChlamydia pneumoniaeMycoplasma pneumoniaeBordetella parapertussisBordetella pertussis	VirusesCoronavirus SARS-CoV-2Human rhinovirusInfluenza A virusInfluenza B virusRespiratory syncytial virus
Analytes	DNA/RNA	RNA
Technological Principles	Highly multiplexed nested nucleic acidamplification test with melt analysis	Same
Instrumentation	SPOTFIRE System	Same
Time to result	About 15 minutes	Same
Reagent Storage	Room Temperature	Same
Test Interpretation	Automated test interpretation and reporting.User cannot access raw data.	Same
Controls	Two controls are included in each reagentpouch to control for sample processing and bothstages of PCR and melt analysis.	Same
User complexity	Low (CLIA-waived)	Same
Panel Software Functions	Defines panel-specific parameters, instrumentprotocols and report requirements.Analyzes processed image data (fluorescenceand temperature data) and provides test results.	Same

Table 2. Similarities and differences between the SPOTFIRE R Panel and the SPOTFIRE R Panel Mini

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March 15, 2023 BioFire Diagnostics, LLC

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Summary of Performance Data:

The performance data for the SPOTFIRE R Panel Mini is identical to the SPOTFIRE R Panel (K213954), but only contains data for the five analytes detected by the SPOTFIRE R Panel Mini (Coronavirus SARS-CoV-2, human rhinovirus, influenza A virus, influenza B virus, and respiratory syncytial virus). Please see the BIOFIRE Respiratory Panel Mini Instructions for Use for performance tables.

Conclusion:

The fundamental scientific technology, performance, and risk of the SPOTFIRE R Panel Mini is unchanged from the legally marketed SPOTFIRE R Panel. There is no change to the product itself, except for modified software that has been verified and validated to show no change in safety and effectiveness. Therefore, the SPOTFIRE R Panel Mini performs as well as the predicate device.

Regulation Number and Section

§ 866.3981 Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.

(a)
Identification. A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: Analytes and targets the device detects and identifies, the specimen types tested, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), the intended use locations including testing location(s) where the device is to be used (if applicable), and other conditions of use as appropriate.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed descriptions of the performance characteristics of the device for each specimen type claimed in the intended use based on analytical studies including the following, as applicable: Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, precision, reproducibility, and clinical studies;
(iii) Detailed descriptions of the test procedure(s), the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) A warning statement that viral culture should not be attempted in cases of positive results for SARS-CoV-2 and/or any similar microbial agents unless a facility with an appropriate level of laboratory biosafety (
e.g., BSL 3 and BSL 3+, etc.) is available to receive and culture specimens; and(v) A prominent statement that device performance has not been established for specimens collected from individuals not identified in the intended use population (
e.g., when applicable, that device performance has not been established in individuals without signs or symptoms of respiratory infection).(vi) Limiting statements that indicate that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) There is a risk of incorrect results due to the presence of nucleic acid sequence variants in the targeted pathogens;
(D) That positive and negative predictive values are highly dependent on prevalence;
(E) Accurate results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(F) When applicable (
e.g., recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer-reviewed literature), that the clinical performance may be affected by testing a specific clinical subpopulation or for a specific claimed specimen type.(4) Design verification and validation must include:
(i) Detailed documentation, including performance results, from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, as appropriate, additional characterized clinical samples. The clinical study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator that FDA has determined is appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses.
(ii) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as Failure Modes Effects Analysis and/or Hazard Analysis. This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel respiratory pathogen isolates or strains (
e.g., regular review of published literature and periodic in silico analysis of target sequences to detect possible mismatches). All results of this protocol, including any findings, must be documented and must include any additional data analysis that is requested by FDA in response to any performance concerns identified under this section or identified by FDA during routine evaluation. Additionally, if requested by FDA, these evaluations must be submitted to FDA for FDA review within 48 hours of the request. Results that are reasonably interpreted to support the conclusion that novel respiratory pathogen strains or isolates impact the stated expected performance of the device must be sent to FDA immediately.(iii) A detailed description of the identity, phylogenetic relationship, and other recognized characterization of the respiratory pathogen(s) that the device is designed to detect. In addition, detailed documentation describing how to interpret the device results and other measures that might be needed for a laboratory diagnosis of respiratory infection.
(iv) A detailed device description, including device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including molecular target(s) for each analyte, design of target detection reagents, rationale for target selection, limiting factors of the device (
e.g., saturation level of hybridization and maximum amplification and detection cycle number, etc.), internal and external controls, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported signal and result), as applicable.(v) A detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(vi) For devices intended for the detection and identification of microbial agents for which an FDA recommended reference panel is available, design verification and validation must include the performance results of an analytical study testing the FDA recommended reference panel of characterized samples. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(vii) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens, the design verification and validation must include a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the Influenza A and B viruses that the device is designed to detect, a description of how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory identification of Influenza A or B virus and of specific Influenza A virus subtypes, and a description of the clinical and epidemiological parameters that are relevant to a patient case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. An evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(5) When applicable, performance results of the analytical study testing the FDA recommended reference panel described in paragraph (b)(4)(vi) of this section must be included in the device's labeling under § 809.10(b) of this chapter.
(6) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens in addition to detection of SARS-CoV-2 and similar microbial agents, the required labeling under § 809.10(b) of this chapter must include the following:
(i) Where applicable, a limiting statement that performance characteristics for Influenza A were established when Influenza A/H3 and A/H1-2009 (or other pertinent Influenza A subtypes) were the predominant Influenza A viruses in circulation.
(ii) Where applicable, a warning statement that reads 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.
(iii) Where the device results interpretation involves combining the outputs of several targets to get the final results, such as a device that both detects Influenza A and differentiates all known Influenza A subtypes that are currently circulating, the device's labeling must include a clear interpretation instruction for all valid and invalid output combinations, and recommendations for any required followup actions or retesting in the case of an unusual or unexpected device result.
(iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces negative test results for all specific influenza A subtypes intended to be differentiated (
i.e., H1-2009 and H3), this result requires notification of appropriate local, State, or Federal public health authorities to determine necessary measures for verification and to further determine whether the specimen represents a novel strain of Influenza A.(7) If one of the actions listed at section 564(b)(1)(A) through (D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those influenza viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized influenza viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's labeling required under § 809.10(b) of this chapter that accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's website, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the website containing this information and must allow unrestricted viewing access.