The BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

Device Description

The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal and nasal swabs of symptomatic patients. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. It is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single test device. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other management decisions. All negative test results should be confirmed by another methodology, such as a nucleic acid-based method.

BD Veritor™ System Flu A+B test devices are interpreted by a BD Veritor™ Plus Analyzer. When using the BD Veritor™ Plus Analyzer, workflow steps depend on the selected operational mode and the Analyzer configuration settings. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Depending on the configuration chosen by the operator, the instrument communicates status and results to the operator via a liquid crystal display (LCD) on the instrument, a connected printer, or through a secure connection to the facility's information system.

AI/ML Overview

This document (K223016) is a 510(k) Premarket Notification for a modified version of the BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit. The core assay (the rapid immunoassay for Influenza A and B detection) remains unchanged from previous clearances (K180438 and earlier). The modifications focus on the accompanying instrument, the BD Veritor™ Plus Analyzer.

Therefore, the document explicitly states "There have been no changes to the analytical performance of the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit since the assay was last cleared in K180438. The modifications to the Analyzer do not have an impact on the assay-specific analytical performance. " and "There have been no changes to the clinical performance of the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit since the assay was last cleared in K180438. The modifications to the Analyzer do not have an impact on the assay-specific clinical performance."

This means that no new performance studies (analytical or clinical) were conducted for the assay itself as part of this specific 510(k) submission. The acceptance criteria and performance data for the assay would refer to the studies presented in the previous 510(k)s, most recently K180438.

The testing performed for this K223016 submission focuses solely on the modifications made to the BD Veritor™ Plus Analyzer:

Overvoltage Protection Circuitry: Testing confirms that the added circuitry does not affect the function of the trigger board (recognition of a cartridge and USB connection).
Extended Lifetime: Verification that the Analyzer performs up to 10,000 cycles (tests) within current specifications (increased from 3,500 tests).
InfoWiFi Module Functionality: Verification of the general functionalities of the new InfoWiFi module, which provides wireless communication capabilities.

Since the provided document does not contain the details of the analytical and clinical performance studies for the assay, and instead refers to previous submissions, I cannot extract the specific acceptance criteria and detailed study data for the assay itself from this text.

Assuming the request is for the acceptance criteria and study proving the changes to the analyzer meet the criteria, the following applies:

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

Feature Modified	Acceptance Criteria (Implicit from testing purpose)	Reported Device Performance (as stated in document)
Analyzer Trigger Board (Overvoltage Protection)	The added overvoltage protection circuitry must not affect the function of the trigger board, meaning it must still properly recognize an inserted cartridge and maintain USB connection functionality.	Testing was performed to confirm that the added overprotection circuitry does not affect the function of the trigger board (recognition of a cartridge and the USB connection).
Analyzer Lifetime	The Analyzer must perform up to 10,000 cycles (tests) while maintaining current specifications (an increase from the previous 3,500 test specified lifetime).	Testing was performed to confirm that the Analyzer performs up to 10,000 cycles within the current specifications.
InfoWiFi Module	The InfoWiFi module must operate according to its intended design, providing general functionalities such as wireless communication capability (same functional features as InfoScan, plus wireless).	Testing was performed to verify general functionalities of the InfoWiFi module.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the document for any of the new tests. The document refers to "testing was performed."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would typically be non-clinical, in-house verification testing by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a device modification verification, not a clinical study requiring expert ground truth for diagnostic accuracy. The "truth" here is engineering functionality.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of diagnostic results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study is for evaluating human reader performance with or without AI assistance. The modifications here are to the hardware of an automated test reader, not an AI diagnostic algorithm.

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

The BD Veritor System itself operates as a standalone diagnostic device interpreted by the analyzer. However, the algorithm for interpreting the test results (analyzing line intensity) was established in previous submissions (K180438) and is stated as "Same" and "Original" in the comparison table, meaning it was not changed or re-evaluated in this submission. The testing done for this 510(k) relates to the hardware modifications of the analyzer, not a new or modified interpretation algorithm.

7. The type of ground truth used:

For the hardware modifications, the "ground truth" is defined by engineering specifications and expected functionality. For example, for "overvoltage protection," the ground truth is "does the circuit protect against overvoltage without impairing core function?" For "lifetime," the ground truth is "does the device successfully complete 10,000 tests?" For "InfoWiFi," the ground truth is "does it perform the specified wireless functionalities?"

8. The sample size for the training set:

Not applicable. This is hardware verification, not a machine learning model.

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

Not applicable.

Summary

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January 27, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

BD Dung Nguyen Senior Staff, Regulatory Affairs 7 Loveton Cir Sparks, Maryland 21152

Re: K223016

Trade/Device Name: BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit Regulation Number: 21 CFR 866.3328 Regulation Name: Influenza Virus Antigen Detection Test System Regulatory Class: Class II Product Code: PSZ Dated: September 27, 2022 Received: September 29, 2022

Dear Dung Nguyen:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Himani Bisht -S

Himani Bisht, Ph.D. Assistant Director 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) K223016

Device Name

BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit

Indications for Use (Describe)

Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation according to the Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses.

If infection with a novel influenza 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 virulenza viruses and sent to the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

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)

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510(k) Summary

BD Veritor 114 System for Rapid Detection of Flu A+B CLIA-Waived Kit

Summary Preparation Date:

9/27/2022

Submitted by:

BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Cir. Sparks, MD 21152 Establishment Registration Number: 1119779

Primary Contact:

Dung Nguyen Sr. Staff, Regulatory Affairs Tel: 424-452-8128 Email: dung.nguyen3@bd.com

Alternate Contact:

Michelle Bowerman Director, Regulatory Affairs Tel: 269-254-4802 Email: michelle.bowerman@bd.com

Proprietary Names:

BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit

Common Names:

Devices Detecting Influenza A, B, and C Virus Antigens

Regulatory Information

Regulation section: 21 CFR 866.3328 Classification Name: Devices Detecting Influenza A, B, and C Virus Antigens Classification: Class 2 Panel: Microbiology Product Code(s): PSZ

Predicate Device

BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit (K112277, K132692, K151291, K160161, K180438)

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BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit 510(k) BD Diagnostic Systems Becton, Dickinson and Company

Device Establishment

Becton, Dickinson and Company 7 Loveton Cir. Sparks, MD 21152 Registration Number: 1119779

Performance Standards

Not applicable.

Intended Use

The BD Veritor™ System for Rapid Detection of Flu A+B CLIA waived assay is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation according to the Morbidity Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011- 2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses.

If infection with a novel influenza 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 the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Special Instrument Requirements:

The BD Veritor "M System for Rapid Detection of Flu A+B CLIA Waived Kit is intended for use with the BD Veritor™ Plus Analyzer.

Device Description

A. Summary

The BD Veritor"M System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from

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nasopharyngeal and nasal swabs of symptomatic patients. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. It is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single test device. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other management decisions. All negative test results should be confirmed by another methodology, such as a nucleic acid-based method.

B. Test Principle

The BD Veritor™ Flu A+B test is an immuno-chromatographic assay for detection of influenza A and B viral antigens in samples processed from respiratory specimens. The viral antigens detected by the BD Flu A+B test are nucleoprotein, not hemagglutinin (HA) or neuraminidase (NA) proteins. Flu viruses are prone to minor point mutations (i.e., antigenic drift) in either one or both of the surface proteins (i.e., HA or NA). The BD Flu A+B test is not affected by antigenic drift or shift because it detects the highly conserved nucleoprotein of the influenza viruses. To perform the test, the patient specimen swab is treated in a supplied reaction tube prefilled with a lysing agent that serves to expose the target viral antigens, and then expressed through a filter tip into the sample well on a BD Veritor™ Flu A+B test device. Any influenza A or influenza B viral antigens present in the specimen bind to antiinfluenza antibodies conjugated to colloidal gold micro-particles on the Veritor™ Flu A+B test strip. The antigen-conjugate complex then migrates across the test strip to the capture zone and reacts with either Anti-Flu A or Anti-Flu B antibodies that are immobilized on the two test lines on the membrane.

The BD Flu A+B test device shown in Figure 1 is designed with five spatially distinct zones including positive and negative control line positions, separate test line positions for the target analytes, and a background zone. The test lines for the target analytes are labeled on the test device as 'A' for flu A position, and 'B' for flu B position. The onboard positive control ensures the sample has flowed correctly and is indicated on the test device as 'C'. Two of the five distinct zones on the test device are not labeled. These two zones are an onboard negative control line and an assay background zone. The active negative control feature in each test identifies and compensates for specimen-related, nonspecific signal generation. The remaining zone is used to measure the assay background.

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	Positive Ctrl	C
	Flu B test line	L4
	Flu A test line	L3
	Negative Ctrl	L2
	Background

Figure 1. BD Veritor™ System Flu A+B Test Device

C. System Components

The Veritor™ System is made up of assay kits with analyte specific reagents and a portable optoelectronic interpretation instrument.

D. Flu A+B CLIA-Waived Kit Contents

The components included in the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived test kit (Catalog # 256045) are detailed in Table 1.

Component	Quantity	Description of Component
BD Veritor™ SystemFlu A+B TestDevices	30 Test Devices	Foil pouched device containing one reactivestrip. Each strip has two test lines of antibodiesspecific to either influenza A or influenza B viralantigen, and positive and negative control lines.
RV Reagent D	30 tubes with 400 µLreagent	Detergent with < 0.1% sodium azide (preservative).
Flexible minitipflocked swab	30 each	Swab for nasopharyngeal or nasal collection.
Control A+/B-	1 each	Flu A positive and Flu B negative control swab,influenza A antigen (inactive recombinantnucleoprotein) with < 0.1% sodium azide.
Control B+/A-	1 each	Flu B positive and Flu A negative control swab,influenza B antigen (inactive recombinantnucleoprotein) with < 0.1% sodium azide.

Table 1: Contents of the Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit

E. Instrument

The instrument used with the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit is the BD Veritor™ Plus Analyzer (also referred to as the Analyzer).

The Analyzer is a digital immunoassay instrument that uses a reflectance-based measurement method and applies assay specific algorithms to determine the presence of the target analyte. The Analyzer supports the use of different assays by reading an assay-specific barcode on the test device. Depending on the configuration chosen by the operator, the instrument communicates status and results to the operator via a liquid crystal display (LCD) on the instrument, a connected printer, or through a secure connection to the facility's information system.

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In the case of the Flu A + B test, the BD Veritor™ Plus Analyzer subtracts nonspecific signal at the negative control line from the signal present at both the Flu B test lines. If the resultant line signal is above a pre-selected assay cutoff, the specimen scores as positive. If the resultant line signal is below the cutoff, the specimen scores as negative. Use of the active control feature allows the BD Veritor™ Plus Analyzer to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal. The measurement of the assay background zone is an important factor during test interpretation as the reflectance is compared to that of the control and test zones. A background area that is white to light pink indicates the device has performed correctly. The instrument does not require calibration. A BD Veritor™ Plus Analyzer can be identified by the image in Figure 2.

Image /page/7/Figure/2 description: The image shows a BD Veritor Plus Analyzer. The analyzer is white and has a screen on top. There is a slot on the side of the analyzer for inserting a test strip. The analyzer is used to test for infectious diseases.

Figure 2. BD Veritor™ Plus Analyzer

The BD Veritor™ Plus Analyzer has the flexibility of an optional bar code scanning module and connectivity module designed to facilitate record keeping as well as the addition of a "Walk Away" workflow mode. Depending on the configuration chosen by the operator, the BD Veritor™ Plus Analyzer communicates status and results to the operator via a liquid crystal display (LCD) on the instrument, a connected printer, or through a secure connection to the facility's information system.

Table 2 lists the components that are included with the BD Veritor™ Plus Analyzer, which is purchased separately from the BD Veritor™ assays.

BD VeritorTM Plus Analyzer	1 each	Portable, rechargeable instrument for interpretation ofBD VeritorTM System test devices
Instructions for Use	1 each	Printed instructions for use
USB Port Unlock Label	1 each	Adhesive label used to unlock the USB port
Compact AC power adapterwith blades for USA, Japan,UK, and EU	1 each	Used to charge the internal rechargeable battery powersource.
BD VeritorTM VerificationCartridge	1 each	Used to verify the proper functionality of theAnalyzer.

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The BD Veritor™ Plus system features a modular architecture that allows users to customize the system to meet their needs. Operators who wish to include data capture and/or secure transmission features may expand the functionality of the system by using optional accessories as described below.

BD Veritor™ InfoScan Module

The BD Veritor™ InfoScan module is inserted into the BD Veritor™ Plus Analyzer to add the capability of reading specimen identification, operator identification, reagent lot information, reagent expiration date, and modifying the on-screen display language of the BD Veritor™ Plus Analyzer. With the BD Veritor™ InfoScan module, users can unlock the unit's data storage to download test information to a connected computer over a USB connection. A BD Veritor™ Plus Analyzer configured with a BD Veritor™ InfoScan module can be identified by the label on its underside, shown in Figure 3.

Image /page/8/Picture/4 description: The image shows a close-up of a device with labels and serial numbers. The top label has a serial number of 012345678901 and a code of 256066. The bottom label has a REF number of 264368 and a serial number of 12345678901.

Figure 3. BD Veritor™ Plus Analyzer Configured with BD Veritor™ InfoScan

BD Veritor™ Plus Connect

When implemented with BD Synapsys TM Informatics Solution, BD Veritor™ Plus Connect enables BD Veritor™ Plus Analyzers equipped with a BD Veritor™ barcode scanning module to securely transmit test results to a facility's information system via an Ethernet connection. The Connect software runs on a separate dedicated computer networked to the BD Veritor™ Plus Analyzer with the USB cable provided with the BD Veritor™ barcode scanning module. This is shown schematically in Figure 4.

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Image /page/9/Figure/1 description: The image shows two electronic devices connected by a cable. The device on the left is a rectangular box with a slot and a USB port on the front. The device on the right is a docking station with a USB port on the back. The cable is plugged into the USB ports on both devices, creating a connection between them. The cable is coiled in the middle.

Figure 4: BD Veritor™ Plus Analyzer Connected to BD Veritor™ Plus Barcode Scanning Module

BD Veritor™ InfoWiFi Module

The BD Veritor™ InfoWiFi module provides the same functional features as the BD Veritor™ InfoScan module and adds wireless communication capability. Once configured, the BD Veritor™ InfoWiFi module can connect to a local wireless network and transmit test results to the BD Synapsys™ Informatics Solution. An additional BD Synapsys™ Informatics subscription is required. A BD Veritor™ Plus Analyzer configured with a BD Veritor™ InfoWiFi module can be identified by the label on its underside, shown Figure 5.

Image /page/9/Picture/5 description: The image shows the back of a device with several labels and markings. There are serial numbers "012345678901" on the top and "12345678901" on the bottom. The bottom label also contains "BD InfoWiFi REF 445010" and the address of Becton, Dickinson and Company in Co. Dublin, Ireland.

Figure 5. BD Veritor™ Plus Analyzer Configured with BD Veritor™ InfoWiFi Module

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Substantial Equivalence -

The subject device, BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit is a modified version of the current legally marketed device, BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit. The predicate 510(k) numbers are K112277, K132259, K132692, K151291, K160161, K180438.

Table 3 provides a comparison between the two versions. In accordance with FDA's Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (July 28, 2014), the modified device is substantially equivalent to the predicate device as described in K180438. There are no changes to the device kit components. The following changes have been made to the VeritorI™ Plus Analyzer:

. The Analyzer's trigger board was modified to incorporate additional circuitry for protection against overvoltage conditions which can occur when a non-BD power supply is used. The trigger board is a secondary board, separate from the main board where all assay-related functionality of the Analyzer is located. The trigger board supports a trigger switch for detection of an inserted assay cartridge and supplies DC power to the Analyzer.
The lifetime number of tests that can be performed on the Veritor™ Plus Analyzer was . extended from 3,500 tests to 10,000 tests.
The optional InfoWiFi module was added to operate as part of the Veritor™ -to-BD ● Synapsys™ Informatics connectivity solution. Previously, the BD Veritor™ InfoScan module was available as an optional module to add the capability of reading specimen identification, operator identification, reagent lot information, reagent expiration date, and modifying the on-screen display language of the Analyzer. The BD Veritor™ InfoWiFi module was developed as an optional module to provide the same functional features as the previously available BD Veritor™ InfoScan module and adds wireless communication capability.

The claim of substantial equivalence is based on the determination that the predicate device is a legally marketed device; the modifications to the Analyzer do not result in a new intended use or different technological characteristics; and the changes do not raise different questions of safety and effectiveness. Non-clinical testing was performed to verify overvoltage protection. lifetime number of tests extension. and the functionalities of the BD Veritor™ InfoWiFi module.

Feature	BD Veritor™ System for RapidDetection of Flu A+B CLIA-WaivedKit (K180438)	Modified BD Veritor™ System forRapid Detection of Flu A+BCLIA-Waived Kit
Intended Use	The BD Veritor™ System for RapidDetection of Flu A+B CLIA waivedassay is a rapid chromatographic	Same
Feature	BD Veritor™ System for RapidDetection of Flu A+B CLIA-WaivedKit (K180438)	Modified BD Veritor™ System forRapid Detection of Flu A+BCLIA-Waived Kit
	immunoassay for the direct andqualitative detection of influenza A andB viral nucleoprotein antigens fromnasal and nasopharyngeal swabs ofsymptomatic patients. The BDVeritor™ System for Rapid Detectionof Flu A+B (also referred to as the BDVeritor™ System and BD VeritorTMSystem Flu A+B) is a differentiatedtest, such that influenza A viral antigenscan be distinguished from influenza Bviral antigens from a single processedsample using a single device. The test isto be used as an aid in the diagnosis ofinfluenza A and B viral infections. Anegative test is presumptive and it isrecommended that these results beconfirmed by viral culture or an FDA-cleared influenza A and B molecularassay. Outside the U.S., a negative testis presumptive and it is recommendedthat these results be confirmed by viralculture or a molecular assay cleared fordiagnostic use in the country of use.FDA has not cleared this device for useoutside of the U.S. Negative test resultsdo not preclude influenza viral infectionand should not be used as the sole basisfor treatment or other patientmanagement decisions. The test is notintended to detect influenza C antigens.
	Performance characteristics forinfluenza A and B were establishedduring January through March of 2011when influenza viruses A/2009 H1N1,A/H3N2, B/Victoria lineage, andB/Yamagata lineage were thepredominant influenza viruses incirculation according to the Morbidityand Mortality Weekly Report from theCDC entitled "Update: InfluenzaActivity—United States, 2010-2011Season, and Composition of the 2011-2012 Influenza Vaccine." Performancecharacteristics may vary against otheremerging influenza viruses.
Feature	BD Veritor™ System for RapidDetection of Flu A+B CLIA-WaivedKit (K180438)	Modified BD Veritor™ System forRapid Detection of Flu A+BCLIA-Waived Kit
	If infection with a novel influenza virusis suspected based on current clinicaland epidemiological screening criteriarecommended by public healthauthorities, specimens should becollected with appropriate infectioncontrol precautions for novel virulentinfluenza viruses and sent to the state orlocal health department for testing.Virus culture should not be attempted inthese cases unless a BSL 3+ facility isavailable to receive and culturespecimens.
Specimen Types	Nasal and nasopharyngeal swabs	Same
Assay Technology	Chromatographic immunoassay	Same
Detection Format	An opto-electronic reader determinesthe line intensity at each of the spatiallydefined test and control line positions,interprets the results using a scoringalgorithm and reports a positive,negative or invalid result on the LCDscreen based on pre-set thresholds.	Same
Qualitative orQuantitative	Qualitative	Same
Assay Run Time	Approximately 10 minutes	Same
Control Format	Kit Flu A+/B- dry swab procedural control Kit Flu A-/B+ dry swab procedural control Internal positive control Internal negative control	Same
Detection of Flu Aand B Viruses	Differentiation of Flu A vs. Flu B	Same
INSTRUMENT
Instrument Name	BD Veritor™ Plus Analyzer	Same
Feature	BD Veritor™ System for RapidDetection of Flu A+B CLIA-WaivedKit (K180438)	Modified BD Veritor™ System forRapid Detection of Flu A+BCLIA-Waived Kit
Appearance anddimensions	Image: BD Veritor System	Same
Intended Use	For use with BD Veritor™ System testdevices	Same
FirmwareFunctionalVerification	Verification cartridge supplied witheach Analyzer	Same
Analyzer TriggerBoard	Original	Original + overvoltage protectioncircuitry
Assay typedetermination	Internal camera reads barcode on testdevice	Same
Lifetime	3500 tests24 months from first use34 months from date of manufacture	10,000 tests24 months from first use34 months from date of manufacture
Assay workflowoptions	Analyze Now mode: Assay device isprepared with processed patient sample;user manually times the assaydevelopment and inserts assay devicewhen development time is complete.Walk Away mode: Assay device isprepared with processed patient sample,inserted into the Analyzer immediately.Assay development is automaticallytimed by the instrument and result isdisplayed when development time iscomplete.	Same
Optional Modulesfor Data Captureand Transmission	InfoScan: reads specimen identification,operator identification, reagent lotinformation, reagent expiration date,and modifying the on-screen displaylanguage; download test information toa connected computer over a USBconnection.	InfoWiFi: same functional featuresas the InfoScan. InfoWifi addswireless communication capabilitythrough a secure connection to thefacility's information system.
Electrical
Batteries	Lithium-ion rechargeable battery	Same
AC power adapter	To charge the lithium-ion battery and/oroperate the analyzer from facility power	Same
Feature	BD Veritor™ System for RapidDetection of Flu A+B CLIA-WaivedKit (K180438)	Modified BD Veritor™ System forRapid Detection of Flu A+BCLIA-Waived Kit
Assay positivityalgorithm	Original	Same
Assay cutoffthresholds	Original	Same
Cybersecuritycontrols	To meet requirements for data privacyand anti-hacking protection	Same
USB On-The-Goport	To connect to printer or to a computerto display or print results. Inputfirmware or menu updates from flashdrive.	Same

Table 3: Comparison of Modified Device to Predicate Device

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Analytical Performance

There have been no changes to the analytical performance of the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit since the assay was last cleared in K180438. The modifications to the Analyzer do not have an impact on the assay-specific analytical performance. Testing was performed to confirm (1) that the added overprotection circuity does not affect the function of the trigger board (recognition of a cartridge and the USB connection) (2) that the Analyzer performs up to 10,000 cycles within the current specifications, and (3) to verify general functionalities of the InfoWiFi module.

Clinical Performance Studies

There have been no changes to the clinical performance of the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit since the assay was last cleared in K 180438. The modifications to the Analyzer do not have an impact on the assay-specific clinical performance.

Regulation Number and Section

§ 866.3328 Influenza virus antigen detection test system.

(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(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 (HHS) 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 viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized 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 § 809.10(b) of this chapter compliant labeling that physically 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 physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.