BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System

Q: Who is the manufacturer of BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System?

Bd Integrated Diagnostic Solutions / filed the 510(k) submission for BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System (K230956).

Q: What is the FDA product code for BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System?

QOF. It is classified under 21 CFR 866.3981 as a Class 2 device in the Microbiology panel.

Q: What is the regulatory pathway for BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System?

510(k) clearance (submission type: Traditional).

Q: Does BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System use AI or machine learning?

Yes. BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System (K230956) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Q: What are the predicate devices for BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System?

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

Q: Who can help prepare an FDA 510(k) submission like BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Q: Can an AI/ML device like BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

K230956 · Bd Integrated Diagnostic Solutions / · QOF · Jul 31, 2023 · Microbiology

Device Facts

Record ID	K230956
Device Name	BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System
Applicant	Bd Integrated Diagnostic Solutions /
Product Code	QOF · Microbiology
Decision Date	Jul 31, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3981
Device Class	Class 2
Attributes	AI/ML

Intended Use

BD Respiratory Viral Panel for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT- PCR) test intended for the simultaneous, qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza, and RSV can be similar. BD Respiratory Viral Panel for BD MAX™ System is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and/or RSV infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV- 2, influenza A, influenza B, and RSV viral nucleic acid are generally detectable in NPS and ANS specimens during the acute phase of infection. Positive results do not rule out co-infection with other organisms. The agent(s) detected by the BD Respiratory Viral Panel for BD MAX™ System may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza B, and/or RSV infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. BD Respiratory Viral Panel-SCV2 for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. SARS-CoV-2 viral RNA is generally detectable in NPS and ANS specimens during the acute phase of infection. The BD Respiratory Viral Panel-SCV2 for BD MAX™ System is intended for use as an aid in the diagnosis of SARS-CoV-2 infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. Positive results do not rule out co-infection with other organisms. The agent detected by the BD Respiratory Viral Panel-SCV2 for BD MAX™ System may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2 infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Device Story

The BD Respiratory Viral Panel (BD RVP) and BD RVP-SCV2 are automated, multiplexed, real-time RT-PCR assays performed on the BD MAX System. The system uses nasopharyngeal or anterior nasal swabs collected in transport media. The process is fully automated: sample lysis, total nucleic acid extraction/concentration, reagent rehydration, RT-PCR amplification, and detection. The system uses magnetic affinity beads for extraction and hydrolysis (TaqMan) probes for detection. The BD MAX software automatically interprets results (POS, NEG, UNR) based on amplification of targets and an internal Sample Processing Control (SPC). The device is used in clinical laboratory environments to aid in the differential diagnosis of respiratory infections. Results are provided to healthcare providers to assist in patient management decisions alongside clinical and epidemiological data.

Clinical Evidence

Prospective multi-center clinical study (N=1645 compliant subjects) compared BD RVP to composite comparator algorithms (SARS-CoV-2) or FDA-cleared molecular assays (Flu A/B, RSV). For NPS specimens, SARS-CoV-2 PPA was 98.9% (97.5-99.5%) and NPA 97.7% (96.6-98.5%). Flu A PPA was 96.7% (88.8-99.1%) and NPA 99.5% (99.0-99.8%). RSV PPA was 100% (75.8-100%) and NPA 100% (99.8-100%). Retrospective studies supplemented low-prevalence targets (Flu B, RSV).

Technological Characteristics

Automated system using real-time RT-PCR. Materials: disposable microfluidic cartridges, master mixes, unitized reagent strips, magnetic affinity beads. Detection: hydrolysis (TaqMan) probes with fluorescent reporter/quencher. Targets: SARS-CoV-2 (N1/N2), Flu A (M1), Flu B (M1/HA), RSV (N/M), RNase P (internal control). Connectivity: standalone instrument. Software: BD MAX System software (v5.14A) for automated interpretation.

Indications for Use

Indicated for individuals with signs and symptoms of respiratory tract infection to detect and differentiate SARS-CoV-2, influenza A, influenza B, and/or RSV (BD RVP) or SARS-CoV-2 (BD RVP-SCV2) in nasopharyngeal or anterior nasal swab specimens. 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)

Related Devices

K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay · Hologic, Inc. · Nov 15, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Date: July 31, 2023 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. BD Integrated Diagnostic Solutions/ Kathy Barnecut Staff Regulatory Affairs Specialist Becton, Dickinson & Company 7 Loveton Circle Sparks, Maryland 21152 ## Re: K230956 Trade/Device Name: BD Respiratory Viral Panel (BD RVP) for BD MAX System; BD Respiratory Viral Panel-SCV2 (BD RVP-SCV2) for BD MAX System 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, QQX Dated: April 4, 2023 Received: April 4, 2023 Dear Kathy Barnecut: 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. {1}------------------------------------------------ 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230956 #### Device Name BD Respiratory Viral Panel for BD MAXTM System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System Indications for Use (Describe) BD Respiratory Viral Panel for BD MAXTM System: BD Respiratory Viral Panel for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT- PCR) test intended for the simultaneous, qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza B, and/or respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-COV-2, influenza, and RSV can be similar. BD Respiratory Viral Panel for BD MAX™ System is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and/or RSV infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV- 2, influenza B, and RSV viral nucleic acid are generally detectable in NPS and ANS specimens during the acute phase of infection. Positive results do not rule out co-infection with other organisms. The agent(s) detected by the BD Respiratory Viral Panel for BD MAX™ System may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza B, and/or RSV infection. The results of this test should not be used as the sole basis for other patient management decisions. BD Respiratory Viral Panel-SCV2 for BD MAX™ System: BD Respiratory Viral Panel-SCV2 for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. SARS-CoV-2 viral RNA is generally detectable in NPS and ANS specimens during the acute phase of infection. The BD Respiratory Viral Panel-SCV2 for BD MAX™ System is intended for use as an aid in the diagnosis of SARS-CoV-2 infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. Positive results do not rule out co-infection with other organisms. The agent detected by the BD Respiratory Viral Panel-SCV2 for BD MAX™ System may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2 infection. The results of this test should not be used as the sole basis for diagnosis, treatment management decisions. {3}------------------------------------------------ X Prescription Use (Part 21 CFR 801 Subpart D) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary # BD Respiratory Viral Panel for BD MAX™ System & BD Respiratory Viral Panel-SCV2 for BD MAX™ System #### Summary Preparation Date: 06/30/2022 #### Submitted by: Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 ## Contact: Kathy Barnecut, RAC Staff Regulatory Affairs Specialist Tel: 858-210-2284 Email: kathy.barnecut(@bd.com #### Device Trade Names: BD Respiratory Viral Panel for BD MAX™ System (445373) BD Respiratory Viral Panel-SCV2 for BD MAX™ System (445361) #### Common Names: 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 Information #### Regulation 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 ## Classification: Class II {5}------------------------------------------------ # Panel: Microbiology # Product Code(s): QOF - Multi-Target Respiratory Specimen Nucleic Acid Test Including SARS-CoV-2 And Other Microbial Agents QQX - Respiratory Specimen Nucleic Acid SARS-CoV-2 Test # Predicate Device BioFire Respiratory Panel 2.1 (RP2.1) (DEN200031) ## Device Establishment Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Registration Number: 1119779 ## Performance Standards Class II Special Controls as per 21 CFR 866.3981 Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays, October 9, 2009. ## Intended Use # BD Respiratory Viral Panel for BD MAX™ System: BD Respiratory Viral Panel for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT- PCR) test intended for the simultaneous, qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza, and RSV can be similar. BD Respiratory Viral Panel for BD MAXTM System is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and/or RSV infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV- 2, influenza A, influenza B, and RSV viral nucleic acid are generally detectable in NPS and ANS specimens during the acute phase of infection. {6}------------------------------------------------ Positive results do not rule out co-infection with other organisms. The agent(s) detected by the BD Respiratory Viral Panel for BD MAX™ System may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza B, and/or RSV infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. # BD Respiratory Viral Panel-SCV2 for BD MAX™ System: BD Respiratory Viral Panel-SCV2 for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. SARS-CoV-2 viral RNA is generally detectable in NPS and ANS specimens during the acute phase of infection. The BD Respiratory Viral Panel-SCV2 for BD MAX™ System is intended for use as an aid in the diagnosis of SARS-CoV-2 infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. Positive results do not rule out co-infection with other organisms. The agent detected by the BD Respiratory Viral Panel-SCV2 for BD MAX™ System may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2 infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. ## Special Conditions for Use Statement: For Prescription Use Only For in vitro diagnostic use only ## Special Instrument Requirements: BD Respiratory Viral Panel for BD MAX™ System and BD Respiratory Viral Panel-SCV2 for BD MAXTM System are performed on the BD MAXTM System. ## Device Description The BD Respiratory Viral Panel (BD RVP) and BD Respiratory Viral Panel-SCV2 (BD RVP-SCV2) along with the BD MAXTM System are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, Total Nucleic Acid (TNA) extraction and concentration, reagent rehydration, target nucleic acid {7}------------------------------------------------ amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors RNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. For the BD Respiratory Viral Panel for BD MAX™ System and BD Respiratory Viral Panel-SCV2 for BD MAX™ System, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure. # Test Principle The BD Respiratory Viral Panel for BD MAX™ System and BD Respiratory Viral Panel-SCV2 for BD MAX™ System assays are designed for use with a nasopharyngeal or anterior nasal swabs collected in BD Universal Viral Transport System (UVT) or Copan Universal Transport Media System (UTM). Once collected, the UVT/UTM patient sample is vortexed and 750ul is transferred to the BD Molecular RVP Sample Buffer Tube (SBT) provided with the BD Respiratory Viral Panel for BD MAX™ System. placed in the BD MAX™ System. For all sample types the SBTs are vortexed and then loaded into the BD MAX system along with the Unitized Reagent Strips, Master Mix, Extraction Tubes, and PCR Cartridges. No further operator intervention is necessary. The BD RVP Unitized Reagent Strip contains a combination of lytic and extraction reagents designed to perform cell lysis and TNA extraction. Nucleic acids released from the target organisms are captured on magnetic affinity beads. The beads, together with the bound nucleic acids, are washed and the nucleic acids are eluted by a combination of heat and pH variation. Eluted TNA is added to neutralization buffer, mixed, and transferred to BD Respiratory Viral Panel master mix for rehydration. After reconstitution, the BD MAX™ System dispenses a fixed volume of RT-PCR-ready solution containing extracted nucleic acids into the PCR Cartridge. Microvalves on the cartridge are sealed by the system prior to initiating PCR in order to contain the amplification mixture and thus prevent evaporation and contamination. The amplified cDNA targets are detected using hydrolysis (TaqMan®) probes, labeled at one end with a fluorescent reporter dye (fluorophore), and at the other end, with a quencher moiety. Probes labeled with different fluorophores are used to detect the target analytes in different optical channels of the BD MAX™ System. When the probes are in their native state, the fluorescence of the fluorophore is quenched due to its proximity to the quencher. However, in the presence of target cDNA, the probes hybridize to their complementary sequences and are hydrolyzed by the 5'-3' exonuclease activity of the DNA polymerase as it synthesizes the nascent strand along the cDNA template. As a result, the fluorophores are separated from the quencher molecules and fluorescence is emitted. The amount of fluorescence detected in the optical channels is directly proportional to the quantity of the corresponding probe that is hydrolyzed. The BD MAX™ System monitors these signals at each cycle of the PCR and interprets the data at the end of the reaction to provide qualitative test results for each analyte. {8}------------------------------------------------ #### Substantial Equivalence1 #### Indication for Use Comparison: The BD Respiratory Viral Panel for BD MAX™ System and BD Respiratory Viral Panel-SCV2 for BD MAX™ System have a similar intended use as their predicate device, except for fewer targeted analytes in the BD Respiratory Viral Panel for BD MAX™ System as opposed to the BioFire Respiratory Panel 2.1 (RP2.1), DEN200031. All BD Respiratory Viral Panel for BD MAX™ System analytes are included in the BioFire Respiratory Panel 2.1 (RP2.1). The BD Respiratory Viral Panel-SCV2 for BD MAX™ System has the same analyte target as the BioFire COVID-19 Test 2, K211079/K221460. #### Technological Comparison: The BD MAX™ Assays have similar principle of operation as their predicate, the BioFire Respiratory Panel 2.1 (RP2.1), DEN200031, and BioFire COVID-19 Test 2, K211079/K221460. All assay reagent kits contain the materials required to complete tests and includes the hydration solution, sample buffer, and sample handling components such as transfer pipettes. All assays, subject devices and predicates, are used to test patient samples in a closed system that stores all the necessary reagents for sample preparation reverse transcription, polymerase chain reaction (PCR), and detection in order to isolate, amplify, and detect nucleic acid from multiple pathogens. Minor differences can be observed in the detection chemistry where the BD Respiratory Viral Panel for BD MAX™ System and the BD Respiratory Viral Panel-SCV2 for BD MAX™ System utilize paired reporter and quencher fluorescence labeled probes (TaqMan Technology) as opposed to the BioFire Respiratory Panel 2.1 (RP2.1) and BioFire COVID-19 Test 2 which utilize a two Step Nested multiplex PCR where sequences from the first RT-PCR/PCR are amplified using fluorescence double stranded binding dye. The minor differences between the subject and predicate devices do not raise any new questions of safety or effectiveness. Table 1 provides the similarities and differences between the BD Respiratory Viral Panel for BD MAX™ System and BD Respiratory Viral Panel-SCV2 for BD MAX™ System, respectively, in comparison to their predicate devices. The term "substantial equivalence" as used in this 510(1) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended ander 21 CFR 807, Subpatt E under which a device can be marketed without pre-market approval or reclassification of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws on the courts. {9}------------------------------------------------ | Device and Predicate Device | Subject Device (K230956) | DEN200031 (Predicate Device) | | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade Name | BD Respiratory Viral Panel for BD MAX TM System | BD Respiratory Viral Panel-SCV2 for BD MAX TM System | BioFire Respiratory Panel 2.1 (RP2.1) | | Regulation Number | 21 CFR 866.3981 | 21 CFR 866.3981 | Same | | Regulation Name | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Same | | Product Code | QOF | QQX | QOF | | Device and Device | Predicate | Subject Device (K230956) | DEN200031 (Predicate Device) | | Intended Use | | BD Respiratory Viral Panel for BD MAX™ BD Respiratory Viral Panel-SCV2 for BD System is an automated multiplexed real-MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the polymerase chain reaction (RT-PCR) test intended for the simultaneous, qualitative detection and intended for the simultaneous, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) nasopharyngeal swab (NPS) and anterior specimens from individuals with signs and nasal swab (ANS) specimens from symptoms of respiratory tract infection. individuals with signs and symptoms of SARS-CoV-2 viral RNA is generally respiratory tract infection. Clinical signs and detectable in NPS and ANS specimens symptoms of respiratory tract infection due during the acute phase of infection. to SARS-CoV-2, influenza, and RSV can be similar. The BD Respiratory Viral Panel-SCV2 for BD MAX™ System is intended for use as an aid in the diagnosis of SARS-CoV-2 BD Respiratory Viral Panel for BD MAX™ System is intended for use as an aid in the infection if used in conjunction with other differential diagnosis of SARS-CoV-2, clinical and epidemiological information, influenza A, influenza B, and/or RSV and laboratory findings. infection if used in conjunction with other clinical and epidemiological information, Positive results do not rule out co-infection with other organisms. The agent detected by and laboratory findings. SARS-CoV-2, with other organisms. The agent(s) detected by influenza A, influenza B, and RSV viral the BD Respiratory Viral Panel-SCV2 for nucleic acid are generally detectable in NPS BD MAX™ System may not be the and ANS specimens during the acute phase definitive cause of disease. of infection. Negative results do not preclude SARS-CoV-2 infection. Positive results do not rule out co-infection with other organisms. The agent(s) detected | The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR based multiplexed nucleic acid test intended for use with the BIOFIRE FilmArray 2.0 or BIOFIRE FilmArray Torch systems 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, including COVID-19. The following organism types and subtypes are identified using the BIOFIRE RP2.1: • Adenovirus • Coronavirus 229E • Coronavirus HKU1 • Coronavirus NL63 • Coronavirus OC43 • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) • Human Metapneumovirus • Human Rhinovirus/Enterovirus • Influenza A, including subtypes H1, H1-2009, and H3 • Influenza B • Parainfluenza Virus 1 • Parainfluenza Virus 2 • Parainfluenza Virus 3 • Parainfluenza Virus 4 • Respiratory Syncytial Virus • Bordetella parapertussis (IS1001) | | Device and Device | Predicate | Subject Device (K230956) | DEN200031 (Predicate Device) | | | | by the BD Respiratory Viral Panel for BD MAX™ System may not be the definitive cause of disease. | Bordetella pertussis (ptxP) Chlamydia pneumoniae, and Mycoplasma pneumoniae | | | | Negative results do not preclude SARS- CoV-2, influenza A, influenza B, and/or RSV infection. | Nucleic acids from the respiratory viral and bacterial organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. The detection and identification | | | | The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. | of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection is indicative of the presence of the identified microorganism and 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 patient management decisions. | | | | 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 BIOFIRE RP2 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 | | Device and Predicate | Subject Device (K230956) | DEN200031 (Predicate Device) | | | Device | | patient with possible respiratory tract infection. | | | | | | | | Condition for use | For prescription use For in vitro diagnostic use only. | Same | | | Sample Types | Nasopharyngeal swab specimen Nasal swab specimen | Nasopharyngeal swab specimen |…

BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System

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BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System