Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

K222736 · Hologic, Inc. · QOF · May 16, 2023 · Microbiology

Device Facts

• Record ID: K222736
• Device Name: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
• Applicant: Hologic, Inc.
• Product Code: QOF · Microbiology
• Decision Date: May 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3981
• Device Class: Class 2

Intended Use

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This assay is intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B, and RSV infections in humans and is not intended to detect influenza C virus infections. Nucleic acids from the viral organisms identified by this test are generally detectable in NP specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus 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. Positive results do not rule out coinfection with other organisms. The organism(s) detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. This assay is designed for use on the Panther Fusion system. The Hologic RespDirect Collection Kit can be used to collect NP specimens for testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay. Additionally, other NP swabs (not provided with the Hologic RespDirect Collection Kit) may be used to collect NP specimens in 3mL of VTM or UTM.

Device Story

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a multiplexed RT-PCR test performed on the fully automated Panther Fusion system. It processes nasopharyngeal (NP) swab specimens collected in transport media (VTM/UTM or Hologic RespDirect). The system performs automated sample lysis, nucleic acid capture using magnetic particles, elution, and multiplex RT-PCR amplification. It detects SARS-CoV-2 (ORF1ab), Flu A (Matrix), Flu B (Matrix), and RSV (Matrix) using specific fluorescent channels. The system compares fluorescence signals against predetermined cut-offs to provide qualitative results and cycle threshold (Ct) values. Used in clinical laboratories by trained personnel, the output aids healthcare providers in the differential diagnosis of respiratory infections. It benefits patients by providing rapid, simultaneous identification of multiple common respiratory viruses, facilitating appropriate clinical management.

Clinical Evidence

Prospective clinical study (n=1900) compared Panther Fusion assay to composite comparator algorithm (SARS-CoV-2) or FDA-cleared molecular assay (Flu A/B/RSV). SARS-CoV-2 PPA 96.9%, NPA 98.5%. Flu A PPA 98.4%, NPA 99.7%. Flu B and RSV performance supplemented by retrospective study (n=95). Analytical studies included precision, reproducibility, inclusivity, cross-reactivity, and interference testing.

Technological Characteristics

Multiplex real-time RT-PCR; automated nucleic acid extraction using magnetic particles; fluorescent-labeled probes (ROX, FAM, RED647, HEX, RED677 channels). Platform: Panther Fusion system (software v7.2.5). Reagents: Panther Fusion SARS-CoV-2/Flu A/B/RSV assay cartridge. Specimen collection: NP swabs in VTM/UTM or eSTM (RespDirect Kit).

Indications for Use

Indicated for qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and RSV RNA in nasopharyngeal (NP) specimens from individuals with signs and symptoms of respiratory tract infection. For prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BioFire Respiratory Panel 2.1 (RP2.1) (DEN200031)

Submission Summary (Full Text)

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Hologic, Inc. Vlada Rudenko Regulatory Affairs Specialist 10210 Genetic Center Drive San Diego, California 92121

Re: K222736

Trade/Device Name: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay 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, OOI Dated: September 8, 2022 Received: September 9, 2022

Dear Vlada Rudenko:

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Joseph Briggs -S

Joseph Briggs, Ph.D. Deputy Branch Chief Viral Respiratory and HPV Branch 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) K222736

Device Name Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Indications for Use (Describe)

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in viro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This assay is intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B, and RSV infections in humans and is not intended to detect influenza C virus infections.

Nucleic acids from the viral organisms identified by this test are generally detectable in NP specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the identified virus 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 for diagnosis, treatment, or other patient management decisions.

Positive results do not rule out coinfection with other organism(s) detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. This assay is designed for use on the Panther Fusion system.

The Hologic RespDirect Collection Kit can be used to collect NP specimens for testing with the Panther Fusion

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

| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY

# K222736

# Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Hologic, Inc. I. 510(k) Owner: 10210 Genetic Center Drive San Diego, CA 92121

- Contact Person: Vlada Rudenko, MA Regulatory Affairs Specialist [e-mail] Phone: [phone] Fax: N/A
- Date Prepared: May 15, 2023

# II. DEVICE

| Proprietary Name: | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Classification Name: | Multi-Target Respiratory Specimen Nucleic Acid Test Including<br>SARS-CoV-2 And Other Microbial Agents |
| Regulation Number: | 21 CFR 866.3981 |
| Regulatory Class: | Class II |
| Product Code: | QOF |
| Secondary Product Code: | OOI |

# III. PREDICATE DEVICE

The predicate device for the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is the BioFire Respiratory Panel 2.1 (BioFire RP2.1) Assay (DEN200031; granted March 17, 2021, BioFire Diagnostics, LLC).

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# IV. DEVICE DESCRIPTION

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a multiplex real-time reverse transcriptase PCR (RT-PCR) in vitro diagnostic test developed for use on the fully automated Panther Fusion system to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) directly from nasopharyngeal (NP) swab specimens collected into UTM/VTM or with the Hologic RespDirect Collection Kit, from individuals exhibiting signs and symptoms of a respiratory tract infection.

The Hologic RespDirect Collection Kit is intended for the collection of NP swab specimens. Each individual collection kit is comprised of a single flocked NP swab and an enhanced Direct Load Tube (eDLT) containing 2.9mL of enhanced Specimen Transport Media (eSTM) which are flow wrapped together for customer convenience.

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay involves the following steps: a) Sample lysis; Prior to processing and testing on the Panther Fusion system, specimens are transferred to a tube containing specimen transport media (STM) that lyses the cells, releases target nucleic acid and protects them from degradation during storage. For specimens collected with the Hologic RespDirect Collection Kit, the swab is placed directly into the eDLT where the eSTM that lyses the cells, releases the nucleic acid and protects them from degradation during storage.

b) Nucleic acid capture and elution takes place in a single tube on the Panther Fusion system. The eluate is transferred to the Panther Fusion system reaction tube containing the assay reagents. The Internal Control-S (IC-S) is added to the Panther Fusion Capture Reagent-S (FCR-S) which gets added to each specimen. The IC-S in the reagent is used to monitor specimen processing, amplification, and detection. Magnetic particles with covalently bound oligonucleotides mediate the nucleic acid capture. Capture oligonucleotides hybridize to total nucleic acid in the test specimen. Hybridized nucleic acid is then separated from the lysed specimen in a magnetic field. Wash and aspiration steps remove extraneous components debris from the reaction tube. The elution step elutes purified nucleic acid.

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c) Elution transfer and multiplex RT-PCR; Eluted nucleic acid is transferred to a Panther Fusion reaction tube already containing oil and reconstituted master mix. A reverse transcriptase generates a DNA copy of the target sequence. Target specific forward and reverse primers and probes then amplify targets while simultaneously detecting and discriminating multiple target types via multiplex RT-PCR. The Panther Fusion system compares the fluorescence signal to a predetermined cut-off to produce a qualitative result for the presence or absence of the analyte. The positive result for each analyte will be accompanied by the cycle threshold (Ct value). The analytes and the channel used for their detection on the Panther Fusion system is summarized in the table below.

| Analyte | Gene Targeted | Instrument Channel |
|---------------------------------|----------------|--------------------|
| SARS-CoV-2 | ORF1ab | ROX |
| Influenza A Virus | Matrix | FAM |
| Respiratory Syncytial Virus A/B | Matrix | HEX |
| Influenza B Virus | Matrix | RED647 |
| Internal Control | Not applicable | RED677 |

*Internal Control is a non-infectious synthetic nucleic acid sequence that is extracted and detected through targeted primers and probes.

#### Assay Components

The reagents required to perform the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay are packaged and sold separately. There are 7 boxes containing 9 reagents which are required for sample processing. The Hologic RespDirect Collection Kit can be used to collect NP specimens for testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay. Additionally, other NP swabs (not provided with the Hologic RespDirect Collection Kit) may be used to collect NP specimens in 3mL of VTM or UTM. A description of the components that are required to perform the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and the Hologic RespDirect Collection kit is detailed in Table 1. Boxes 3 - 7 were cleared by FDA as part of K171963.

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## Table 1: Reagents Required to Perform the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assav

| Box | Components Description | Part Number |
|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 1 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Cartridges -<br>96 Tests<br>Panther Fusion SARS-CoV-2/Flu A/B/RSV assay cartridge, 12<br>tests, 8 per box | PRD-07400 |
| 2 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Controls<br>Positive Control tube, 5 per box<br>Panther Fusion Negative Control tube, 5 per box | PRD-07401 |
| 3 | Panther Fusion Extraction Reagent-S - 960 Tests<br>Panther Fusion Capture Reagent-S bottle, 240 tests, 4 per box<br>Panther Fusion Enhancer Reagent-S bottle, 240 tests, 4 per box | PRD-04331 |
| 4 | Panther Fusion Internal Control-S - 960 Tests<br>Panther Fusion Internal Control-S tube, 4 per box | PRD-04332 |
| 5 | Panther Fusion Reconstitution Buffer I - 1920 Tests<br>Panther Fusion Reconstitution Buffer I pack, 960 tests, 2 per box | PRD-04333 |
| 6 | Panther Fusion Elution Buffer - 2400 Tests<br>Panther Fusion Elution Buffer pack, 1200 tests, 2 per box | PRD-04334 |
| 7 | Panther Fusion Oil Reagent - 1920 Tests<br>Panther Fusion Oil Reagent pack, 960 tests, 2 per box | PRD-04335 |

# Ancillary Kits:

| 1 | Panther Fusion Specimen Lysis Tubes<br>(100 tubes) | PRD-04339 |
|---|------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 2 | Hologic RespDirect Collection Kit<br>Collection kit composed of 1 flocked NP swab and 1 tube<br>containing 2.9mL eSTM), 50 per box | PRD-07788 |

In addition, select components can also be ordered in the following bundles:

- Panther Fusion Universal Fluids Kit: (contains Panther Fusion Oil and Panther Fusion ● Elution Buffer).
- Panther Fusion Assay Fluids Kit I-S: (contains Panther Fusion Extraction Reagents-S, ● Panther Fusion Internal Control-S, and Panther Fusion Reconstitution Buffer I).

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#### Instrumentation

The Panther Fusion system integrates Hologic's commercialized Panther instrument system with an add-on sidecar, the Panther Fusion module, which extends the functionality of the Panther system by increasing the assay processing capabilities to include real-time PCR (RT-PCR). The Panther Fusion module includes instrument hardware and can be installed on existing Panther instruments or ordered with new Panther instruments.

The Panther Fusion system employs non-specific target capture (NSTC) for the purification of RNA and DNA from the sample, followed by nucleic acid amplification and real-time fluorescent detection. The process involves sample loading and preparation (i.e. nucleic acid extraction) on the Panther instrument using similar workflow and processing steps as for other commercialized Hologic Aptima TMA assays. The extracted nucleic acid for each sample is transferred to the Panther Fusion module where PCR amplification and detection occurs.

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay has been designed for and validated on the Panther Fusion system. The Panther Fusion system fully automates all the steps necessary to perform the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.

#### V. INDICATIONS FOR USE

#### Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

The Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed realtime polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A). influenza B virus (Flu B) and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and

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Image /page/8/Picture/0 description: The image is the logo for Hologic. The word "HOLOGIC" is written in large, bold, blue letters. To the right of the word is a registered trademark symbol. Below the word is a series of vertical blue lines, followed by the words "The Science of Sure" in a smaller font.

symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar. This assay is intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B and RSV infections in humans and is not intended to detect influenza C virus infections.

Nucleic acids from the viral organisms identified by this test are generally detectable in NP specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus 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.

Positive results do not rule out coinfection with other organisms. The organism(s) detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. This assay is designed for use on the Panther Fusion system.

The Hologic® RespDirect™ Collection Kit can be used to collect NP specimens for testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay. Additionally, other NP swabs (not provided with the Hologic RespDirect Collection Kit) may be used to collect NP specimens in 3mL of VTM or UTM.

# Ancillary Collection Kit:

#### Hologic RespDirect Collection Kit

The Hologic® RespDirect™ Collection Kit is intended to be used for the collection of nasopharyngeal (NP) swab specimens (collected by a healthcare provider) for testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay.

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Panther Fusion®

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

A comparison of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay to the predicate BioFire Respiratory Panel 2.1 (DEN200031) is summarized in Table 2.

# Table 2: Comparison of Similarities and Differences Between the Subject Device (Panther Fusion SARS-CoV-2/Flu AB/RSV Assay) and the Predicate Device (BioFire Respiratory Panel 2.1 (RP2.1))

| Item | Panther Fusion<br>SARS-CoV-2/Flu A/B/RSV Assay<br>(Subject Device) | BioFire Respiratory Panel 2.1 (RP2.1)<br>(Predicate Device)<br>DEN200031 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription<br>Use Only | Yes | Same |
| Specimen<br>Types | Nasopharyngeal (NP) swab specimens | Same |
| Intended User | Professional use | Same |
| Technology<br>Principle of<br>Operation | Reverse transcriptase multiplexed polymerase chain<br>reaction test | Same |
| Organisms<br>Detected | 4 targets including: | Same, however the BioFire RP 2.1 includes additional<br>targets (listed below) |
| | SARS-CoV-2 | Adenovirus |
| | Flu A | Coronavirus 229E |
| | Flu B | Coronavirus HKU1 |
| | RSV (A and B) | Coronavirus NL63 |
| | | Coronavirus OC43 |
| | | Severe Acute Respiratory Syndrome Coronavirus 2<br>(SARS-CoV-2) |
| | | Human Metapneumovirus |
| | | Human Rhinovirus/Enterovirus |
| | | Panther Fusion |
| | | Influenza A, including subtypes H1, H1-2009, and<br>H3 |
| | | Influenza B |
| | | Parainfluenza Virus 1 |
| | | Parainfluenza Virus 2 |
| | | Parainfluenza Virus 3 |
| | | Parainfluenza Virus 4 |
| | | Respiratory Syncytial Virus |
| | | Bordetella parapertussis (IS1001) |
| | | Bordetella pertussis (ptxP) |
| | | Chlamydia pneumoniae |
| | | Mycoplasma pneumoniae…