(28 days)
Not Found
No
The device description details a rapid chromatographic immunoassay interpreted by an optoelectronic instrument using assay-specific algorithms for signal subtraction and comparison to a cutoff. There is no mention of AI or ML techniques for image analysis, pattern recognition, or learning from data. The algorithms described are deterministic and based on predefined thresholds.
No
The device is for the detection and diagnosis of influenza, not for treatment or therapy. Its intended use is as an aid in the diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "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 BD Veritor System includes both assay kits with reagents (hardware) and an optoelectronic interpretation instrument (hardware), in addition to the software/firmware that interprets the results. It is not solely 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 purpose, performed on a sample taken from the human body.
- Device Description: It describes a "rapid chromatographic immunoassay" that detects viral antigens in "samples processed from respiratory specimens." This is a laboratory test performed outside of the body (in vitro) to diagnose a condition.
- Regulatory Information: The mention of "FDA-cleared influenza A and B molecular assay" and "FDA has not cleared this device for use outside of the U.S." indicates that the device is subject to regulatory oversight for in vitro diagnostic devices. The classification as a "CLIA waived kit" also points to its use in a clinical laboratory setting for diagnostic testing.
All of these points 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. Outside the U.S., a negative test is presumptive and it is recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA has not cleared this device for use outside of the U.S. 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.
Product codes (comma separated list FDA assigned to the subject device)
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. All BD Veritor System Flu A+B test devices are interpreted by a BD Veritor System Instrument, either a BD Veritor Reader or BD Veritor Plus Analyzer.
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
The data in this table summarizes the performance of the Veritor Flu A + B assay test system across all age groups
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
At the BD Diagnostics Systems research and development center in San Diego, CA, staff performed studies on both analytical and clinical samples to confirm that the performance of the Veritor Plus Analyzer is equivalent to the Veritor Reader when used in both Read Now and Walk-Away modes.
These studies included:
- Reproducibility studies
- Samples with true zero values (no analyte)
- High negative and low positive samples (near cut-off samples)
The data collected using analytical samples demonstrated that the percentage positivity for Veritor Readers and Veritor Plus Analyzers are equivalent.
The R&D staff also performed assessments of the following clinical samples:
- 102 Flu A-/B- samples
- 52 Flu A+ samples
- 52 Flu B+ samples
The data collected with clinical samples also indicate that assay results obtained using Veritor Readers and Veritor Plus Analyzers are either identical or statistically equivalent. Results included less than 2% either False Positive or False Negative results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
POC: BD Flu A
PPA: 83.6% (76.1%, 89.1%)
NPA: 97.5% (95.7%, 98.5%)
POC: BD Flu B
PPA: 81.3% (71.1%, 88.5%)
NPA: 98.2% (95.7%, 99.3%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K112277, K132259, K132692, K151291, K160161
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
March 20, 2018
Becton, Dickinson and Company Mary Ann Fiechtner Regulatory Affairs Specialist 10865 Road to the Cure Suite 200 San Diego, California 92121
Re: K180438
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 systems Regulatory Class: Class II Product Code: PSZ Dated: February 15, 2018 Received: February 20, 2018
Dear Mary Ann Fiechtner:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tamara V. Feldblyum -S for
Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known)
K 180438
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 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. Outside the U.S., a negative test is presumptive and it is recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA has not cleared this device for use outside of the U.S. 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 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.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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5. 510(K) SUMMARY
| DATE PREPARED: | March 16, 2018 |
|---|---|
| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY |
| 10865 Road to the Cure, Suite 200 | |
| San Diego, CA 92121 | |
| Tel: (858) 795-7857 | |
| Fax: (858) 812-8505 | |
| CONTACT NAME: | Mary Ann Fiechtner, RAC |
| Regulatory Affairs Specialist | |
| DEVICE TRADE NAME: | BD Veritor™ System for Rapid Detection of Flu A + B |
| CLIA-Waived Kit | |
| DEVICE COMMON NAME: | Influenza Virus Antigen Detection Test System |
| DEVICE CLASSIFICATION: | 21 CFR 866.3328 |
| CLASSIFICATION: | CLASS 2 |
| PANEL: | Microbiology |
| PREDICATE DEVICES : | BD Veritor™ System for Rapid Detection of Flu A+B |
| CLIA waived kit (K112277, K132259, K132692, | |
| K151291, K160161) |
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. Outside the U.S., a negative test is presumptive and it is recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA has not cleared this device for use outside of the U.S. 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
4
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 :
A. Summary
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. All BD Veritor System Flu A+B test devices are interpreted by a BD Veritor System Instrument, either a BD Veritor Reader or BD Veritor Plus Analyzer.
B. Principle of the Test
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 12. 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-coniugate 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.
1 Shu, L.L., Bean, W.J., and Webster, R.G. 1993. Analysis of the evolution and variation of the human influenza A virus nucleoprotein gene from 1933 to 1990. J. Virol. 67:2723-2729.
2 Kendal, A.P., and Dowdle, W.R. 1986. Influenza Virus p. 515. Manual of Clinical Laboratory Immunology, 30 edition, In Lenette et. Al. (ed.). American Society for Microbiology, Washington, D.C.
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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.
| | Positive Ctrl
Flu B test line
Flu A test line
Negative Ctrl
Background | C
L4
L3
L2 | |
| -- | ------------------------------------------------------------------------------------ | --------------------- | -- |
|---|
Fiqure 1. BD Veritor Flu A + B Assay Device
C. System Components
The Veritor System is made up of assay kits with analyte specific reagents and an optoelectronic interpretation instrument.
D. Flu A + B CLIA waived assay kit contents
The components included in the BD Veritor System for Rapid Detection of Flu A+B CLIA waived test kit (BD product #256045) are detailed in Table 1.
| Table 1: Contents of the Veritor System for Rapid Detection of Flu A + B CLIA waived | ||
|---|---|---|
| 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 less than 0.1% sodium azide | |
| (preservative) | ||
| Flexible minitip | ||
| flocked swab | 30 each | Swab for nasopharyngeal or nasal collection |
| Control A+/B- | 1 each | Flu A positive and flu B negative control swab, |
| influenza A antigen (inactive recombinant | ||
| nucleoprotein) with less than 0.1% sodium azide | ||
| Control B+/A- | 1 each | Flu B positive and flu A negative control swab, |
| influenza B antigen (inactive recombinant | ||
| nucleoprotein) with less than 0.1% sodium azide |
E. Veritor™ System Interpretation Instruments
The BD Veritor System instruments use a reflectance-based measurement method and apply assay specific algorithms to determine the presence or absence of the target analyte. In the case of the Flu A + B test. the BD Veritor System instruments subtract
6
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 System instruments 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. Sample preparation is the same for use with both instruments, and both can utilize the same kit components. Neither instrument requires calibration.
The Veritor Reader and the Veritor Plus Analyzer use the functional components and decision algorithm in the firmware. 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" work flow mode. Depending on the configuration chosen by the operator, the 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.
The following components are included with the BD Veritor" "Instruments (purchased separately from Veritor Assays).
| Table 2. Veritor System Instrument components | ||
|---|---|---|
| BD VeritorTM Reader | ||
| BD VeritorTM System | ||
| Reader | 1 each | Portable, rechargeable instrument for interpretation of |
| BD VeritorTM System test devices | ||
| AA Alkaline Batteries | 2 each | Reader arrives ready to use with batteries installed. |
| Instructions for Use | 1 each | Printed instructions for use |
| BD VeritorTM | ||
| Verification Cartridge | 1 each | Used to verify the proper functionality of the Reader. |
| BD VeritorTM Plus Analyzer | ||
| BD VeritorTM Plus | ||
| System Analyzer | 1 each | Portable, rechargeable instrument for interpretation of |
| BD VeritorTM System test devices | ||
| Instructions for Use | 1 each | Printed instructions for use |
| USB Port Unlock Label | 1 each | Adhesive label used to unlock the USB port |
| Compact AC power | ||
| Adapter with blades for | ||
| USA, Japan, UK and | ||
| EU | 1 each | Used to charge the internal rechargeable battery power |
| source. | ||
| BD VeritorTM | ||
| Verification Cartridge | 1 each | Used to verify the proper functionality of the Analyzer. |
Table 2: Veritor System Instrument components
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| BD Veritor™ Plus System InfoScan Module | ||
|---|---|---|
| Barcode scanning module | 1 each | Allows users to capture and record or display user ID, patient ID and/or kit lot ID numbers with an associated assay result |
| Quick Installation guide | 1 each | Pictogram illustrating simple, slide in installation |
| USB Cable (USB-A to micro-B) | 1 each | Allows download of assay results to a connected PC from the secure internal drive. |
| BD Veritor™ Plus System InfoSync Module | ||
| Cellular enabled barcode scanning module | 1 each | Allows users to capture and record user ID, patient ID and/or kit lot ID numbers, and transmit them to a cloud connected LIS system with associated assay results. |
| Quick Installation guide | 1 each | Pictogram illustrating simple, slide in installation |
Table 3: Optional Veritor System accessory module compnents
DEVICE COMPARISON:
The device labeling has been changed to reflect the addition of a new data table and explanation in the Clinical Performance section. This appears as Table 1 in the Package Insert as shown below.
Table 1: Summary of Performance Data of the BD Veritor System for Rapid Detection of Flu A + B Compared to PCR for All Swabs - All Sites.
Note: The data in this table summarizes the performance of the Veritor Flu A + B assay test system across all age groups, clinical testing sites and sample types. The 95% Confidence intervals are calculated using an analysis that accounts for sources of heterogeneity.
| Reference PCR | Reference PCR | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| POC: BD Flu | ||||||||||
| A | P | N | Total | POC: BD Flu | ||||||
| B | P | N | Total | |||||||
| P | 189 | 13 | 202 | P | 139 | 10 | 149 | |||
| N | 37 | 497 | 534 | N | 32 | 555 | 587 | |||
| Total | 226 | 510 | 736 | Total | 171 | 565 | 736 | |||
| Reference Method: PCR | Reference Method: PCR | |||||||||
| PPA: 83.6% (76.1%, 89.1%) | PPA: 81.3% (71.1%, 88.5%) | |||||||||
| NPA: 97.5% (95.7%, 98.5%) | NPA: 98.2% (95.7%, 99.3%) | |||||||||
| Wald 95% Confidence intervals corrected for over-dispersion, where needed, due | ||||||||||
| to potential variability between sites. |
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| Product Feature | Veritor System Reader | Veritor Plus Analyzer |
|---|---|---|
| GENERAL: | ||
| Appearance and | ||
| dimensions | Image: Veritor System Reader with dimensions ~77mm, ~60mm, ~120mm | Image: Veritor Plus Analyzer with dimensions ~90mm, ~67mm, ~140mm |
| Intended use | For use with BD Veritor | |
| System test devices | Same | |
| Firmware | ||
| functional | ||
| verification | Verification cartridge supplied | |
| with each Reader | Same | |
| Assay type | ||
| determination | Internal camera reads | |
| barcode on test device | Same | |
| Assay test device | ||
| compatibility | Original | Same |
| Lifetime | 3000 tests | |
| 24 months from first use | ||
| 34 months from date of | ||
| manufacture | 3500 tests | |
| 24 months from first use | ||
| 34 months from date of manufacture | ||
| Assay workflow | ||
| options | Original or "Analyze Now": | |
| Assay device is prepared with | ||
| processed patient sample, | ||
| user manually times the | ||
| assay development and | ||
| inserts assay device when | ||
| development time is | ||
| complete. | Analyze Now: unchanged Walk-Away: 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. | ||
| Qualitative or | ||
| Quantitative Result | Qualitative | Qualitative, unchanged |
| Optional modular | ||
| barcode scanner | Not Present | Captures and records Operator ID, |
| Specimen ID, and/or test device lot | ||
| information. Can be used to configure | ||
| display languages. | ||
| Cellular modem | ||
| available with | ||
| InfoSync module | Not Present | Using HTTPS secure link, endpoint |
| authentication, receipt confirmation. | ||
| Automated connection to LIS/EMR. | ||
| Removable | ||
| module or cover | ||
| plate | Not Present | Analyzers have either a cover plate or |
| are equipped with optional scanning | ||
| module. | ||
| Printer | Not printer compatible | Compatible with external dedicated printer via USB. |
| ELECTRICAL: | ||
| Batteries | User replaceable alkaline AA batteries | Li-ion rechargeable battery |
| AC power adapter | N/A | To charge the Li-ion battery and/or operate the analyzer from facility power. |
| Graphical display | 40 mm x 19 mm | 56 mm x 33 mm |
| Flash Memory | 4 MB | 8 MB |
| FIRMWARE: | ||
| Assay positivity algorithm | Original | Same |
| Assay cutoff thresholds | Original | Same |
| Test menu | Original | Same |
| Cybersecurity controls | Not Present | To meet requirements for data privacy and anti-hacking protection. |
| USB OTG port | Not Present | To connect to printer or to a computer to display or print results. Input firmware or menu updates from flash drive. |
| Display languages | English or Japanese only | Six user selectable languages; English, French, Italian, German, Spanish, Swedish. (optional scanning module required for language configuration). Japanese model sold separately |
Table 5: Comparison of Veritor System Reader and Veritor Plus Analyzer
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SUBSTANTIAL EQUIVALENCE:
The modified BD Veritor™ System Flu A+ B CLIA waived kit is substantially equivalent to the current legally marketed, BD Veritor™ System Flu A+B CLIA waived kit. Additions made to the labeling to add the performance data table and to allow interpretation with the Veritor Plus Analyzer have changed neither the intended use of the device nor the fundamental scientific technology.
RISK ASSESSMENT SUMMARY:
The BD Diagnostic Systems Risk Assessment process is based on the BD Risk Management procedure, which meets the requirement for risk management as set forth in ISO 14971:2007 and EN ISO 14971:2012. Using this procedure, the following are estimated:
- the Hazard.
- I the Adverse Effect (Harm to Patient),
- . the Potential Causes of the Hazard,
- The probability of Hazard Severity and
- . The probability of Occurrence
Based on a resulting calculated risk index, risk control measures are identified, required verification and validation activities are determined, and verification of the effectiveness of risk control measures is determined.
RESULTS OF THE RISK ANALYSIS:
-
- Addition of the inclusion of the additional performance table in the Clinical Performance section of the BD Veritor™ System Flu A+ B CLIA-Waived assay product insert does not create any new product risks, or issues of safety and effectiveness.
Additions to labeling are as follows:
- Addition of the inclusion of the additional performance table in the Clinical Performance section of the BD Veritor™ System Flu A+ B CLIA-Waived assay product insert does not create any new product risks, or issues of safety and effectiveness.
| Change | Potential Impact of Change |
|---|---|
| Addition of performance data re-analyses | Additional information provided to users regarding performance of the device. |
-
- The risk assessment identified the need to confirm the Veritor Plus System's ability to produce assay results equivalent to those obtained with the Veritor Reader in either Analyze Now or Walk Away work flow mode. The identified studies were performed according to appropriate design control procedures to assess the addition of the Veritor Plus Analyzer in either mode as an interpretation instrument for the Veritor System Flu A + B CLIA-Waived assay product. The results of testing did not identify new issues of safety and effectiveness.
-
- The risk assessment identified the need to confirm that the addition of the bar code scanning functions of InfoScan and InfoSync modules, and any associated screen displays, alerts and error messages had no effect on safety or effectiveness when
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the Veritor Plus Analyzer was used with the Veritor CLIA-waived Flu A + B Assay. Software verification activities were performed and all testing criteria were met to confirm that changes and addtions made to firmware to add new functionality had no impact on the abiltiy of the instrument to give a correct assay result.
-
- Cybersecurity risks and vulnerabilities associated with the use of the InfoSync module were assessed and BD procedures and controls were verified as acceptable to protect user and patient data.
-
- The risk assessment also identified the need to confirm that the Veritor Plus Analyzer was simple and easy to use in the CLIA waived environment.
SUMMARY OF PERFORMANCE STUDIES:
At the BD Diagnostics Systems research and development center in San Diego, CA, staff performed studies on both analytical and clinical samples to confirm that the performance of the Veritor Plus Analyzer is equivalent to the Veritor Reader when used in both Read Now and Walk-Away modes.
These studies included:
- · Reproducibility studies
- o Samples with true zero values (no analyte)
- o High negative and low positive samples (near cut-off samples)
The data collected using analytical samples demonstrated that the percentage positivity for Veritor Readers and Veritor Plus Analyzers are equivalent.
The R&D staff also performed assessments of the following clinical samples:
- 102 Flu A-/B- samples ●
- 52 Flu A+ samples .
- 52 Flu B+ samples ●
The data collected with clinical samples also indicate that assay results obtained using Veritor Readers and Veritor Plus Analyzers are either identical or statistically equivalent. Results included less than 2% either False Positive or False Negative results.