BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
K232434 · Bd · PSZ · Dec 5, 2023 · Microbiology
Device Facts
Record ID
K232434
Device Name
BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
Applicant
Bd
Product Code
PSZ · Microbiology
Decision Date
Dec 5, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3328
Device Class
Class 2
Indications for Use
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 Story
Rapid chromatographic immunoassay for influenza A and B viral nucleoprotein antigens. Input: nasal/nasopharyngeal swabs processed in lysing agent. Operation: specimen applied to test device; antigen-gold conjugate complex migrates to capture zone; anti-Flu A/B antibodies immobilized on membrane capture complex. BD Veritor Plus Analyzer (reflectance-based reader) interprets results by subtracting nonspecific signal at negative control line from test line signals. Analyzer provides results via LCD, printer, or facility information system. Used in clinical settings by healthcare professionals. Benefits: rapid, differentiated diagnosis of Flu A and B; active negative control compensates for nonspecific signal generation. Modifications include added LCD shield and enhanced ESD/battery protection circuitry.
Clinical Evidence
No clinical data. Bench testing only. Non-clinical testing verified that Analyzer modifications did not impact assay-specific analytical performance or device functionality.
Technological Characteristics
Immunochromatographic assay; reflectance-based opto-electronic reader. Powered by rechargeable Li-ion battery or AC adapter. Features include barcode scanning, LCD display, and USB connectivity. Firmware V6.00. Hardware includes ESD-protected PCBA and protective shield. Complies with IEC 60601-1-2.
Indications for Use
Indicated for symptomatic patients requiring qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs. Not for detection of influenza C.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
BD Veritor TM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016)
Related Devices
K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit · Bd · Jan 27, 2023
K132693 — BD Veritor System Flu A+B Assay · Becton, Dickinson and Company · Oct 2, 2013
K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit · Bd · Mar 20, 2018
K151301 — BD Veritor System Flu A+B Assay · Becton, Dickinson and Company · Jun 8, 2015
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K232434
B Applicant
BD
C Proprietary and Established Names
BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PSZ | Class II | 21 CFR 866.3328 - Influenza Virus Antigen Detection Test System | MI - Microbiology |
## II Submission/Device Overview:
### A Purpose for Submission:
This traditional 510(k) submission for the BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit was submitted by BD to obtain clearance (SE) for the device after making hardware modifications to the analyzer with associated updates to the instrument software (firmware).
There were no changes to the kit, reagents, procedure to perform the test and therefore no new analytical and clinical data were required with these revisions. The intended use of the device and its underlying scientific technology remain unchanged.
### B Measurand:
Influenza A Nucleoprotein Antigen
Influenza B Nucleoprotein Antigen
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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C Type of Test:
Lateral flow immunochromatography
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
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.
### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
### D Special Instrument Requirements:
The BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit is intended for use with the BD Veritor Plus Analyzer.
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IV Device/System Characteristics:
# A 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.
When specimens are processed and added to the assay test device, any influenza A or B antigens present in the specimen bind to anti-influenza antibodies conjugated to colloidal gold microparticles on the Veritor Flu A+B test strip. The antigen-conjugate complexes migrate 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 Veritor test devices are designed with five spatially distinct reaction zones including:
- a separate test line position for each target analyte (Flu A and Flu B),
positive and negative control line positions, 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.
Positive Ctrl
Flu B test line
Flu A test line
Negative Ctrl
Background
C
L4
L3
L2
The BD Veritor System consists of a dedicated opto-electronic interpretation instrument and immunochromatographic assays for the qualitative detection of antigens from pathogenic organisms in samples processed from respiratory specimens. The assay included in this application is intended for interpretation in both laboratory and near-patient testing environments only with the BD Veritor Plus Analyzer Instrument ("the Analyzer") and is not interpreted visually.
The Analyzer is a portable, electronic instrument that uses a reflectance-based measurement method to evaluate line signal intensities on the assay test device. It applies assay-specific firmware algorithms to determine the presence or absence of target analyte(s). The Analyzer is powered by a rechargeable Li-ion battery and compact wall transformer, is intended for tabletop or benchtop use, and follows the original BD Veritor instrument model of a calibration-free
K232434 - Page 3 of 10
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limited lifetime based on the number of tests performed, the number of days from first use, and/or the maximum shelf life from the date of manufacture. By design, the Analyzer has few external means for user input or output. Operation requires minimal operator interaction to complete testing and to report results. Analyzer workflow procedures depend on the instrument configuration selected by the user. In Analyze Now mode, the instrument evaluates assay test devices after manual timing of their incubation. In Walk Away mode, test devices are inserted immediately after application of the specimen, and timing of assay incubation and analysis is automated. In either case, assay results are provided to the operator on the liquid crystal display (LCD) display screen. Additional result documentation capabilities are possible with the use of a BD Veritor bar code scanning module, which can capture, display and/or integrate barcoded specimen, operator or kit information in the test record.
This 510(k) application includes validation of the changes made to the analyzer to add a plastic shield to the Analyzer’s enclosure and in front of the 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. A new firmware (V6.00) was developed to support the analyzer’s new hardware features.
## B Principle of Operation:
Immunochromatographic separation of influenza A or B antigen-antibody complexes detected via opto-electronic reader.
## C Instrument Description Information:
1. Instrument Name:
BD Veritor Plus Analyzer
2. Specimen Identification:
Specimens ID’s may be manually entered or scanned via the barcode scanner.
3. Specimen Sampling and Handling:
Swab samples from nasopharyngeal or nasal swabs are manually transferred to test kit reagent tubes for elution and drop-wise addition to the test cassette. Freshly collected samples should be processed within 1 hour.
4. Calibration:
Not Applicable
5. Quality Control:
The test includes a positive control to ensure adequate migration of the reagents through the test membrane to the desired test line locations for the reader. The test also contains a negative control to test for non-specific binding and two background test regions to measure
K232434 - Page 4 of 10
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assay background when calculating test line signal strength. Each kit also contains positive control swabs for Influenza A and Influenza B. It is the manufacturer's recommendation that positive controls be run after every new kit lot, a new operator performs the test, a new shipment of test kits is received, and as required by local, state, and federal regulations.
V Substantial Equivalence Information:
A Predicate Device Name(s):
BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit
B Predicate 510(k) Number(s):
K223016
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K232434 | K223016 |
| --- | --- | --- |
| Device Trade Name | BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit | BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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 | Same |
K232434 - Page 5 of 10
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K232434 - Page 6 of 10
| | 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. | |
| --- | --- | --- |
| **General Device Characteristic Differences** | | |
| Specimen Types | Nasal and nasopharyngeal swabs | Same |
| Assay Technology | Immunochromatographic | Same |
| Detection Format | An opto-electronic reader determines the line intensity at each of the spatially defined test and control line positions, interprets the results using a scoring algorithm and reports a positive, negative or invalid result on the LCD screen based on pre-set thresholds. | Same |
| **Instrument** | | |
| Instrument name | BD Veritor Plus Analyzer | Same |
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| Appearances and dimensions | | Same |
| --- | --- | --- |
| Intended use | For use with BD Veritor System test devices | Same |
| Firmware functional verification | Verification cartridge supplied with each Analyzer | Same |
| Assay type determination | Internal camera reads barcode on test device | Same |
| Lifetime | 10,000 tests
24 months from first use
34 months from date of manufacture | 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. | Same |
| 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 | The BD Veritor InfoWiFi 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. Adds wireless | Same |
K232434 - Page 7 of 10
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| | 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 |
| Firmware | | |
| 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 |
VI Standards/Guidance Documents Referenced:
IEC 60601-1-2
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
This traditional 510(k) submission for the BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit was submitted by BD to obtain clearance (SE) for the device following hardware modifications to the analyzer and related updates to the instrument software (firmware). No new analytical studies were needed with these revisions because the kit, reagents, and the procedure to perform the test remain unchanged. Therefore, all the analytical performance characteristics hereafter are noted as “not applicable”. Please refer to K223016 for the analytical performance data.
1. Precision/Reproducibility:
Not applicable
2. Linearity:
This is a qualitative test and linearity is not applicable.
K232434 - Page 8 of 10
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3. Analytical Specificity/Interference:
Not applicable
4. Assay Reportable Range:
Not applicable
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Not applicable
6. Detection Limit:
Not applicable
7. Assay Cut-Off:
Not applicable
8. Accuracy (Instrument):
Not applicable
9. Carry-Over:
Not applicable
## B Comparison Studies:
No changes were made to the kit, reagents, and procedure to perform the test since K220316. See K220316 for more information.
1. Method Comparison with Predicate Device:
Not applicable
2. Matrix Comparison:
Not applicable
## C Clinical Studies:
This traditional 510(k) submission for the BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit was submitted by BD to obtain clearance (SE) for the device following hardware modifications to the analyzer and related updates to the instrument software (firmware). No new clinical study was needed with these revisions because the kit, reagents, and the procedure to perform the test remain unchanged. Therefore, all the clinical performance
K232434 - Page 9 of 10
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characteristics hereafter are noted as "not applicable". Please refer to K223016 for the clinical performance data.
1. Clinical Sensitivity:
Not applicable
2. Clinical Specificity:
Not applicable
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
None
D Clinical Cut-Off:
The Clinical Cut-Off remains unchanged. See K220316 for more information.
E Expected Values/Reference Range:
Expected Values remain unchanged. See K220316 for more information.
F Other Supportive Instrument Performance Characteristics Data:
Not applicable
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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