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

Device Description

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

The BD Veritor™ System Flu A+B CLIA-Waived Kit 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"10 Flu A+B test device. Any influenza A or influenza B viral antigens present in the specimen bind to anti-influenza antibodies conjugated to colloidal gold micro-particles on the BD 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.

The BD Veritor™ Plus Analyzer is a digital immunoassay instrument that uses a reflectance-based measurement method and applies assay specific algorithms to determine the presence or absence 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.

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 A and 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 negative 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for modifications to the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit. The current submission (K232434) focuses on changes to the BD Veritor™ Plus Analyzer, not the assay itself. Therefore, the details about acceptance criteria and clinical performance studies relate to the predicate device (K223016) and the assay's original clearance (K180438), as the modifications in K232434 do not impact the assay's analytical or clinical performance.

Here's a breakdown based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance

The current submission (K232434) is for modifications to the analyzer, not a new or modified assay. Therefore, it does not present new acceptance criteria or device performance data for the assay's diagnostic accuracy. Instead, it relies on the previously established performance of the predicate device (K223016) which itself relies on the performance established in K180438. The acceptance criteria for the current submission are related to the safety and electromagnetic compatibility of the modified analyzer.

Acceptance Criteria (for Analyzer Modifications in K232434)	Reported Device Performance (for Analyzer Modifications in K232434)
Compliance with Safety Requirements for Electrical Equipment (IEC 61010-1:2010, IEC 61010-1:2010/AMD 1:2016, IEC 61010-2-101:2018)	Demonstrated compliance with specified standards
Compliance with Electromagnetic Compatibility and Electrical Safety (EN IEC 61326-1:2020, EN IEC 61326-2-6:2021, EN 60601-1-2:2015 + A1: 2021 [equivalence of ANSI AAMI IEC 60601-1-2:2014 including AMD 1:2021])	Demonstrated compliance with specified standards; No EMI nor ESD susceptibility observed during compliance testing. Analyzer functionalities remained the same, and operations and performance were not impacted.

Performance Characteristics for Influenza A and B (as established for K180438 / K223016 and referenced here):

The document mentions that performance characteristics for influenza A and B were established during January through March of 2011. While specific sensitivity and specificity values are not provided in this document excerpt, the "Indications for Use" and "Intended Use" sections clearly state that the device is for "direct and qualitative detection of influenza A and B viral nucleoprotein antigens."

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not include the specific sample size for the test set used to establish the clinical performance of the Flu A+B assay, nor does it explicitly state the data provenance (e.g., retrospective or prospective studies) in detail, beyond mentioning:

"Performance characteristics for influenza A and B were established during January through March of 2011"
This period corresponded to when "influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation" in the United States, according to CDC reports. This implies real-world, clinical data from symptomatic patients in the US during that influenza season was used.

Since the current submission is for analyzer modifications and explicitly states, "Clinical Performance: Clinical performance testing was not required because the changes made to the Analyzer do not have an impact on the assay-specific clinical performance," this information would be found in the original submission (K180438) that cleared the assay.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the given text. It would be part of the detailed clinical study report from the original assay clearance (K180438).

4. Adjudication Method for the Test Set

This information is not provided in the given text. It would be part of the detailed clinical study report from the original assay clearance (K180438).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to the BD Veritor System. This device is a rapid chromatographic immunoassay read by a digital analyzer (BD Veritor™ Plus Analyzer), not an AI system designed to assist human readers in interpreting complex images or data. The analyzer automatically interprets the test results based on its algorithms and provides a positive, negative, or invalid result, rather than providing input to a human reader for their interpretation.

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

Yes, in essence, the BD Veritor™ Plus Analyzer operates as a standalone algorithm without human-in-the-loop performance for result interpretation. The text states:

"The Analyzer is a digital immunoassay instrument that uses a reflectance-based measurement method and applies assay specific algorithms to determine the presence or absence of the target analyte."
"The BD Veritor™ Plus Analyzer subtracts nonspecific signal at the negative control line from the signal present at both the Flu A and 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 negative 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."

This clearly describes an automated interpretation process by the device's algorithms.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document states, "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." This implies that viral culture or an FDA-cleared influenza A and B molecular assay served as the reference standard (ground truth) for establishing performance characteristics during the original clinical studies.

8. The Sample Size for the Training Set

This information is not provided in the given text, and it's less relevant for an immunoassay where "training data" for a machine learning model might not be explicitly defined in the same way as for complex AI algorithms. For immunoassays, the "training" involves optimizing the assay reagents and conditions, and setting cutoff values, which are then validated with clinical samples.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the given text. As mentioned above, the concept of a "training set ground truth" might not apply directly in the traditional sense for this type of immunoassay. Instead, the ground truth for establishing performance (and implicitly for setting cutoffs) would be established using the reference methods mentioned in point 7.

Summary

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December 5, 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

BD Michelle Bowerman Director, Regulator Affairs 7 Loveton Cir. Sparks, MD 21152 USA

Re: K232434

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 6, 2023 Received: September 7, 2023

Dear Michelle Bowerman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Digitally signed by Silke Silke Schlottmann -S Schlottmann -S Date: 2023.12.05 13:03:32 -05'00'

Silke Schlottmann, Ph.D. Deputy Branch Chief Bacteriology Respiratory and Medical Countermeasures 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) K232434.S001

Device Name

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

Indications for Use (Describe)

The BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit 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 CLIA-Waived Kit (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 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 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 HINI, 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.

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)	X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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

DATE PREPARED:	August 11, 2023
SUBMITTED BY:	BD Diagnostic SystemsBecton, Dickinson and Company7 Loveton Cir.Sparks, MD 21152Establishment Registration Number: 1119779
CONTACT NAME:	Primary Contact:Michelle BowermanDirector, Regulatory AffairsTel: (269) 254-4802Email: michelle.bowerman@bd.com
PROPRIETARY NAME:	BD Veritor™ System for Rapid Detection of Flu A+BCLIA-Waived Kit
COMMON NAME:	Devices Detecting Influenza A, B, and C Virus Antigen

REGULATION INFORMATION:

Regulatory Section	21 CFR 866.3328
Classification Name	Devices Detecting Influenza A, B, and C VirusAntigens
Device Class	Class 2
Panel	Microbiology
Product Code	PSZ

PREDICATE DEVICE:	BD Veritor TM System for Rapid Detection of Flu A+BCLIA-Waived Kit (K223016)
DEVICE ESTABLISHMENT:	Becton, Dickinson and Company
	7 Loveton Cir.
	Sparks, MD 21152
	Registration Number: 1119779

INTENDED USE

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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

A. Summary

B. Test Principle

There are no changes to the test principle since the assay was cleared under K223016. The modifications described in this submission do not change the test principle. The following is the principle of the test as stated in K223016.

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Image /page/5/Picture/2 description: The image shows a rapid influenza diagnostic test (RIDT) device, along with a diagram explaining the test lines. The test device has a window labeled "FLU" and another with the letters "CBA". The diagram indicates the location of the positive control line (C), Flu B test line (L4), Flu A test line (L3), and negative control line (L2).

Figure 1: BD Veritor™ Flu A+B Assay Device

C. Flu A+B CLIA Waived Kit Contents

There are no changes to the contents of the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit (Catalog # 256045) since the assay was cleared under K223016. The modifications described in this submission do not change the contents of the subject device. Table 1 summarizes the contents in provided in the BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit (Catalog # 256045).

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Component	Quantity	Description of Component
BD Veritor™ System FluA+B Test Devices	30 Test Devices	Foil pouched device containing onereactive strip. Each strip has two testlines of antibodies specific to eitherinfluenza A or influenza B viralantigen, and positive and negativecontrol lines.
RV Reagent D	30 tubes with 400uL reagent	Detergent with < 0.1% sodium azide(preservative).
Flexible minitip flockedswab	30 each	Swab for nasopharyngeal or nasalcollection.
Control A+/B-	1 each	Flu A positive and Flu B negativecontrol swab, influenza A antigen(inactive recombinant nucleoprotein)with < 0.1% sodium azide.
Control B+/A-	l each	Flu B positive and Flu A negativecontrol swab, influenza B antigen(inactive recombinant nucleoprotein)with < 0.1% sodium azide.

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

D. Instrumentation

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

The Analyzer is a digital immunoassay instrument that uses a reflectance-based measurement method and applies assay specific algorithms to determine the presence or absence 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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The instrument does not require calibration. A BD Veritor™ Plus Analyzer can be identified by the image in Figure 2.

Image /page/7/Picture/1 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 left side of the analyzer and a biohazard symbol on the right side.

Figure 2. BD Veritor™ Plus Analyzer

The BD Veritor™ Plus Analyzer has the flexibility of an optional bar code scanning module and cellular connectivity 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 Veritor™ Plus Analyzer	1 each	Portable, rechargeable instrument for interpretation of BD Veritor™ 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 adapter with blades for USA, Japan, UK, and EU	1 each	Used to charge the internal rechargeable battery power source.
BD Veritor™ Verification Cartridge	1 each	Used to verify the proper functionality of the Analyzer.

Table 2: BD VeritorTM Plus Analyzer Components
------------------------------------------------

The BD Veritor 114 Analyzer can be used with the optional accessories such as the BD Veritor™ InfoWiFi and the BD Veritor™ Plus Connect.

There are no changes to the assay cut-off values, analyzing algorithm, assay barcoding or accessories to the Analyzer since K223016.

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DESCRIPTION OF THE CHANGES

This traditional 510(k) is submitted for modifications to the BD Veritor TM Plus Analyzer previously cleared with the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016).

The Analyzer was modified to add a plastic shield to the Analyzer's enclosure and in front of the liquid crystal display (LCD) screen to protect the screen from being damaged when a high electrostatic discharge (ESD) voltage is applied. The main printed circuit board assembly (PCBA) was modified to add enhanced ESD and battery protection. The modified Analyzer was tested and demonstrated compliance with the following standards:

Safety Requirements for ElectricalEquipment	IEC 61010-1:2010, IEC 61010-1:2010/AMD 1:2016IEC 61010-2-101:2018 for use in conjunction withIEC 61010-1:2010, AMD 1:2016
Electromagnetic compatibility andelectrical safety	EN IEC 61326-1:2020EN IEC 61326-2-6:2021EN 60601-1-2:2015 + A1: 2021 (the equivalence ofANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021])

A new firmware (v6.00) was developed to support the Analyzer's new hardware features including switch monitoring, power path monitoring and control. The Instructions for Use for the BD Veritor™ Plus Analyzer will be updated to reflect conformance to the electromagnetic compatibility and electrical safety standards.

There are no changes to the subject device's intended use, kit components, or technological characteristics.

Table 3 provides a comparison between previously cleared device and the modified device.

Feature	BD Veritor™ System for Rapid Detection ofFlu A+B CLIA Waived Kit(K223016)	BD Veritor™ System forRapid Detection of Flu A+BCLIA Waived Kit (K232434.S001)
Intended Use	The BD Veritor™ System for Rapid Detectionof Flu A+B CLIA-Waived Kit is a rapidchromatographic immunoassay for the directand qualitative detection of influenza A and Bviral nucleoprotein antigens from nasal andnasopharyngeal swabs of symptomatic patients.The BD Veritor™ System for Rapid Detectionof Flu A+B (also referred to as the BD VeritorSystem and BD Veritor™ System Flu A+B) isa differentiated test, such that influenza A viralantigens can be distinguished from influenza B	Same

	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 and 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 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.
SpecimenTypes	Nasal and nasopharyngeal swabs	Same
AssayTechnology	Immunochromatographic	Same
DetectionFormat	An opto-electronic reader determines the line intensity at each of the spatially defined test and control line positions, interprets the results	Same
positive, negative or invalid result on the LCDscreen based on pre-set thresholds.
Instrument – BD VeritorTM Plus Analyzer
Appearance anddimensions	Image: BD Veritor Plus Analyzer	Same
Intended use	For use with BD VeritorTM System test devices	Same
LCD Screen	Original	Shield added to LCD screen
Printed CircuitBoardAssembly	Original	Enhanced ESD and batteryprotection circuitry added
Electromagneticcompatibilityand electricalsafety	IEC 61326-1:2012IEC 61326-2-6:2012IEC 60601-1-2 ed 4.0:2014	EN IEC 61326-1:2020EN IEC 61326-2-6:2021ANSI AAMI IEC 60601-1-2:2014 [including Amendment1 (2021)]
Firmware	Version v5.70	Version v6.00
Firmwarefunctionalverification	Verification cartridge supplied with eachAnalyzer	Same
Assay typedetermination	Internal camera reads barcode on test device	Same
Lifetime	10,000 tests24 months from first use34 months from date of manufacture	Same
Optionalmodules for datacapture andtransmission	InfoScan: reads specimen identification,operator identification, reagent lot information,reagent expiration date, and modifying the on-screen display language; download testinformation to a connected computer over aUSB connection.InfoWiFi: same functional features as theInfoScan. InfoWiFi adds wireless	Same
	communication capability through a secureconnection to the facility's informationsystem.
Assay workflowoptions	Analyze Now mode: Assay device is preparedwith processed patient sample; user manuallytimes the assay development and inserts assaydevice when development time is complete.Walk Away mode: Assay device is preparedwith processed patient sample, inserted into theAnalyzer immediately. Assay development isautomatically timed by the instrument andresult is displayed when development time iscomplete.	Same
Electrical
Batteries	Lithium-ion rechargeable battery	Same
AC poweradapter	To charge the lithium-ion battery and/oroperate the analyzer from facility power	Same
Firmware
Assay positivityalgorithm	Original	Same
Assay cutoffthresholds	Original	Same
Cybersecuritycontrols	To meet requirements for data privacy andanti-hacking protection	Same
USB On-The-Go port	To connect to printer or to a computer todisplay or print results. Input firmware or menuupdates from flash drive.	Same

Table 3: Comparison of Predicate Device to Modified Device

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SUBSTANTIAL EQUIVALENCE

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 legally marketed device as described in K223016. The rationale for determination of substantial equivalence is based on the Guidance's' 510(k) Decision-Making Flowchart and described below.

The predicate device, BD Veritor"10 System for Rapid Detection of Flu A+B CLIA-● Waived Kit, is a legally marketed device by BD.
The modified device has the same intended use as the predicate device. ●
The modified device has the same technological characteristics as the predicate device. . The changes made to the Analyzer do not change the technological characteristics of the predicate device. There are no changes to the kit components of the device or to the workflow of performing the assay.
The changes do not raise different questions of safety and effectiveness. Testing was . performed and demonstrated compliance to:

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Safety Requirements for Electrical Equipment	IEC 61010-1:2010, IEC 61010-1:2010/AMD 1:2016IEC 61010-2-101:2018 for use in conjunction withIEC 61010-1:2010, AMD 1:2016
Electromagnetic compatibility and electrical safety	EN IEC 61326-1:2020EN IEC 61326-2-6:2021EN 60601-1-2:2015 + A1: 2021 (the equivalence ofANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021])

Instrument EMI/ESD: No EMI nor ESD susceptibility was observed during compliance . testing. Non-clinical testing results verified that the Analyzer device functionalities remain the same and operations and performance of the Analyzer were not impacted.
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.
Clinical Performance: Clinical performance testing was not required because the . changes made to the Analyzer do not have an impact on the assay-specific clinical performance.

Conclusion: In conclusion, the claim of substantial equivalence is based on the determination that the modifications to the Analyzer do not result in a new intended use or technological performance of the assay. The device is safe and as effective as the legally marketed device (K223016) and does not raise different questions of safety and effectiveness.

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.