(120 days)
No
The summary describes a rapid chromatographic immunoassay interpreted by an analyzer. There is no mention of AI, ML, or image processing for interpretation. The analyzer appears to automate timing and communication, not complex pattern recognition or learning.
No.
The device is for the diagnosis of influenza A and B viral infections, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The test is to be used as an aid in the diagnosis of influenza A and B viral infections."
No
The device description clearly states that the system includes a "BD Veritor™ Plus Analyzer," which is a physical instrument used to interpret the test devices. This indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the device is for the "direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients." This is a diagnostic test performed in vitro (outside the body) on a biological sample.
- Aid in Diagnosis: The intended use also states the test is to be used "as an aid in the diagnosis of influenza A and B viral infections." This clearly indicates its purpose is to provide information for medical diagnosis.
- Sample Type: The test uses "nasal and nasopharyngeal swabs," which are biological specimens collected from a patient.
- Method: It is described as a "rapid chromatographic immunoassay," which is a common method used in IVD tests to detect specific substances (in this case, viral antigens) in a sample.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes
PSZ
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.
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 anti-influenza 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 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 Veritor™ System is made up of assay kits with analyte specific reagents and a portable optoelectronic interpretation 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. 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.
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.
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.
The BD Veritor™ InfoScan module can be 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.
When implemented with BD Synapsys™ 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and nasopharyngeal swabs
Indicated Patient Age Range
symptomatic patients. (No specific age range mentioned beyond symptomatic patients)
Intended User / Care Setting
Not Found (CLIA-Waived specified, implying lay user or minimal training)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 K180438. The modifications to the Analyzer do not have an impact on the assay-specific clinical performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K112277, K132259, K132692, K151291, K160161
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
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 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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3
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)
4
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
5
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.
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.
6
| 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™ System | ||
| Flu A+B Test | ||
| Devices | 30 Test Devices | Foil pouched device containing one reactive |
| strip. Each strip has two test lines of antibodies | ||
| specific to either influenza A or influenza B viral | ||
| antigen, and positive and negative control lines. | ||
| RV Reagent D | 30 tubes with 400 µL | |
| reagent | Detergent with INSTRUMENT | |
| Instrument Name | BD Veritor™ Plus Analyzer | Same |
| Feature | BD Veritor™ System for Rapid | |
| Detection of Flu A+B CLIA-Waived | ||
| Kit (K180438) | Modified BD Veritor™ System for | |
| Rapid Detection of Flu A+B | ||
| CLIA-Waived Kit | ||
| Appearance and | ||
| dimensions | Image: BD Veritor System | Same |
| Intended Use | For use with BD Veritor™ System test | |
| devices | Same | |
| Firmware | ||
| Functional | ||
| Verification | Verification cartridge supplied with | |
| each Analyzer | Same | |
| Analyzer Trigger | ||
| Board | Original | Original + overvoltage protection |
| circuitry | ||
| Assay type | ||
| determination | Internal camera reads barcode on test | |
| device | Same | |
| Lifetime | 3500 tests | |
| 24 months from first use | ||
| 34 months from date of manufacture | 10,000 tests | |
| 24 months from first use | ||
| 34 months from date of manufacture | ||
| Assay workflow | ||
| options | Analyze Now mode: Assay device is | |
| prepared with processed patient sample; | ||
| user manually times the assay | ||
| development and inserts assay device | ||
| when development time is complete. |
Walk Away mode: Assay device is
prepared with processed patient sample,
inserted into the Analyzer immediately.
Assay development is automatically
timed by the instrument and result is
displayed when development time is
complete. | Same |
| Optional Modules
for Data Capture
and Transmission | InfoScan: reads specimen identification,
operator identification, reagent lot
information, reagent expiration date,
and modifying the on-screen display
language; download test information to
a connected computer over a USB
connection. | InfoWiFi: same functional features
as the InfoScan. InfoWifi adds
wireless communication capability
through a secure connection to the
facility's information system. |
| Electrical | | |
| Batteries | Lithium-ion rechargeable battery | Same |
| AC power adapter | To charge the lithium-ion battery and/or
operate the analyzer from facility power | Same |
| Feature | BD Veritor™ System for Rapid
Detection of Flu A+B CLIA-Waived
Kit (K180438) | Modified BD Veritor™ System for
Rapid Detection of Flu A+B
CLIA-Waived Kit |
| Assay positivity
algorithm | Original | Same |
| Assay cutoff
thresholds | Original | Same |
| Cybersecurity
controls | To meet requirements for data privacy
and anti-hacking protection | Same |
| USB On-The-Go
port | To connect to printer or to a computer
to display or print results. Input
firmware or menu updates from flash
drive. | Same |
Table 3: Comparison of Modified Device to Predicate Device
11
12
13
14
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.