← Product Code [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ) · K151301

# BD Veritor™ System Flu A+B Assay (K151301)

_Becton, Dickinson and Company · PSZ · Jun 8, 2015 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K151301

## Device Facts

- **Applicant:** Becton, Dickinson and Company
- **Product Code:** [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ.md)
- **Decision Date:** Jun 8, 2015
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.3328
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Intended Use

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 nasopharyngeal wash-aspirate and swab in transport media samples from symptomatic patients. The BD Veritor System for Rapid Detection of 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 outside 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 nasopharyngeal (NP) washes/aspirates 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. Performance characteristics for influenza A and B NP swabs in transport media were established during January through April of 2012 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, 2011-2012 Season, and Composition of the 2012-2013 Influenza Vaccine." 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

The BD Veritor System is a rapid chromatographic immunoassay used in clinical settings to detect influenza A and B viral nucleoprotein antigens. The device processes nasopharyngeal wash-aspirate or swab samples; the user applies the sample to a test device, which is then inserted into the BD Veritor System Reader. The reader performs an automated analysis of the test strip to provide a qualitative result within 10 minutes. The system distinguishes between influenza A and B antigens. Results are displayed on the reader for the clinician to interpret, aiding in the diagnosis of influenza infections. The device modification involved expanding the analytical reactivity table to include 14 additional influenza strains (9 A, 5 B) to ensure continued detection capability for circulating strains, thereby reducing the risk of false negatives and improving clinical decision-making regarding patient treatment.

## Clinical Evidence

Bench testing only. Analytical reactivity testing was performed to validate the detection of 14 additional influenza A and B strains. The device successfully detected all tested strains at the reported minimal concentrations. No clinical prospective or retrospective studies were required for this modification.

## Technological Characteristics

Rapid chromatographic immunoassay; utilizes BD Veritor System Reader for automated result interpretation. Includes positive and negative control swabs. Analytical reactivity measured via TCID50, CEID50, EID50, and HA titers. No changes to physical materials or sensing principles.

## Regulatory 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™ System for Rapid Detection of Flu Laboratory Kit ([K120049](/device/K120049.md), [K121797](/device/K121797.md), [K132256](/device/K132256.md), [K132693](/device/K132693.md), [K133138](/device/K133138.md))

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification Decision Summary

To: Becton Dickinson and Company

RE: K151301

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II device requiring 510(k). The following items are present and acceptable

1. The name and 510(k) number of the SUBMITTER'S previously cleared device:

Trade Name: BD Veritor™ System Flu A+B assay (Laboratory Kit)

510(k) numbers: k120049, k121797, k132256, k132693, k133138

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling.

3. A description of the device MODIFICATION(S). The modification presented in this 510(k) consisted of expanded analytical reactivity table to include additional analytical reactivity information for 9 strains of the influenza A virus and 5 strains of the influenza B virus, including the minimal concentration detected for all these 14 additional influenza viruses in the analytical reactivity table. The following tables show the viruses tested for this submission and the minimal detected concentration:

|  Strain | Subtype | Minimal Detected Concentration  |
| --- | --- | --- |
|  A/Fujian-Gulou/1896/2009 | H1N1 | 4.50 x 10^{5} CEID_{50}/mL  |
|  A/Washington/24/2012 | H1N1 | 3.16 x 10^{4} EID_{50}/mL  |
|  A/Switzerland//9715293/2013 | H3N2 | 3.25 x 10^{2} TCID_{50}/mL  |
|  A/Texas/50/2012 | H3N2 | 1.75 x 10^{3} TCID_{50}/mL  |
|  A/Anhui/01/2005 | H5N1 | 0.512 HA  |
|  A/Vietnam/1203/2004 | H5N1 | 0.512 HA  |
|  A/Pheasant/New Jersey/1355/1998 | H5N2 | 0.256 HA  |
|  A/Mallard/Netherlands/12/2000 | H7N7 | 0.256 HA  |
|  A/Chicken/Hong Kong/G9/1997 | H9N2 | 1.024 HA  |

TCID50= 50% Tissue Culture Infectious Dose
CEID50= 50% Chicken Embryo Infectious Dose
EID50= 50% Egg Infectious Dose
HA= Hemagglutination Assay Titer

|  Strain | Minimal Detected Concentration  |
| --- | --- |
|  B/Massachusetts/2/2012 (Yamagata Lineage) | 1.25 x 10^{6} CEID_{50}/mL  |
|  B/Montana/5/2012 (Victoria-like) | 3.14 x 10^{5} EID_{50}/mL  |
|  B/Phuket/3073/2013 | 6.08 x 10^{3} TCID_{50}/mL  |
|  B/Texas/06/2011 (Yamagata Lineage) | 6.20 x 10^{5} CEID_{50}/mL  |
|  B/Wisconsin/01/2010 (Yamagata Lineage) | 7.00 x 10^{2} CEID_{50}/mL  |

TCID50= 50% Tissue Culture Infectious Dose
CEID50= 50% Chicken Embryo Infectious Dose
EID50= 50% Egg Infectious Dose

The BD Veritor™ System Flu A+B assay (Laboratory Kit) package insert has been updated to include this additional analytical reactivity information.

4. The FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

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5. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics:

Similarities

|   | Predicate | K151301  |
| --- | --- | --- |
|  Features | BD Veritor™ System Flu A+B assay (Laboratory Kit) | BD Veritor™ System Flu A+B assay (Laboratory Kit)  |
|  Intended Use | 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 nasopharyngeal wash-aspirate and swab in transport media samples from symptomatic patients. The BD Veritor System for Rapid Detection of 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 outside 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 nasopharyngeal (NP) washes/aspirates 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.
Performance characteristics for influenza A and B NP swabs in transport media were established during January through April of 2012 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, 2011-2012 Season, and Composition of the 2012-2013 Influenza Vaccine."
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. | Same  |
|  Read Results | BD Veritor System Reader | Same  |
|  Specimen Types | Nasal swab, nasopharyngeal swab | Same  |
|  Read Result Time | 10 minutes | Same  |
|  External Controls | Test kit contains Positive and Negative Control swabs | Same  |

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3

# Differences

The package insert has been updated to include detection of the additional influenza A and B strains in the analytical reactivity information section and minimal detected concentration information has been listed for these additional viruses in the reactivity table.

The following limitation statement in the package insert has been moved from the "Analytical Sensitivity (Limit of Detection)" section to the "Strain Reactivity with Influenza A and B Viruses" section:

"Although this test has been shown to detect novel avian influenza A (H7N9) and H3N2v cultured viruses the performance characteristics of this device with clinical specimens that are positive for novel avian influenza A (H7N9) and H3N2v influenza viruses has not been established. The BD Veritor™ System Flu A+B assay can distinguish between influenza A and B viruses, but it cannot differentiate influenza A subtypes."

Additional footnotes explaining $\mathrm{TCID}_{50} / \mathrm{mL}$, $\mathrm{EID}_{50} / \mathrm{mL}$, $\mathrm{CEID}_{50} / \mathrm{mL}$, and HA have been added to the "Analytical Sensitivity (Limit of Detection)" table and the "Strain Reactivity with Influenza A and B Viruses" table in the package insert.

## 6. Design Control Activities Summary, which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

BD's Risk Assessment process is based on a BD Product 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,
- the Adverse Effect(Harm to Patient),
- the Potential Causes of the Hazard,
- The probability of Severity and the probability of occurrence are estimated.

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.

*Risk Index:

Insignificant (GR) – individual risks in the green region are deemed negligible in comparison with other risks and in relation to the benefit of using the product. Even if the risk falls into this region, the risk must be reduced as far as possible. For risks falling into this region, the medical benefit is considered to outweigh the individual residual risk since the combination of the occurrence and severity is considered low. These risks do not require individual risk benefit analysis. Because risk of harm in this region are deemed negligible, risk control measures implemented in this region, will not require documented verification of risk control measure effectiveness.

Investigate (YE) – individual risks in the yellow region are not negligible in comparison with other risks, therefore further risk reduction must be investigated. This category requires evaluation for risk reduction and once all possible risk control measures have been implemented, the residual risk is not reduced to insignificant (GR) is not possible, the individual item in this region require a documented risk/benefit analysis to document acceptance of the residual risk (See Attachment 3 for a Risk Benefit Analysis model.

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4

Unacceptable/Intolerable (RE) – individual risks in the red region are unacceptable. This region requires the implementation of risk control measures to reduce the risk. In general, BDDS products should not have items with residual risks falling into this region. However, in an exceptional and rare circumstance, these items may be documented in the risk/benefit analysis with approval by Medical Affairs at a director level or higher.

## RESULTS OF THE ANALYSIS:

The results of the analysis indicated an initial possible combination of severity and occurrence that fell into S-3/P-3 category (i.e., Risk Index of "Investigate"):

|  Hazard | Adverse Effect (Harm) | Probability of Severity | Potential Causes of the Hazard | Probability of Occurrence | Existing Risk Control Measure | Risk Index * | Responsibility for Risk Control Measure | Risk Control Measure  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  False Negative | Effect on patient is that they could be inappropriately treated leading to flu progression | S-3 | Assay does not detect the predicted strains for 2015/2016 Flu Season or other available new and circulating strains | P-3 | Current strain reactivity has been determined and is provided in the Product Insert | YE | R&D | Testing Obtain and test additional flu strains Labeling Update PI with new reactivity after FDA special 510(k) clearance  |

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

To implement the indicated investigation, Protocol SDSP15001 was developed and approved based on previously accepted FDA submissions regarding strain reactivity. Specific influenza strains selection for this reactivity study was based on new circulating strains for 2015/2016 Influenza Season, as well as availability of other strains through CDC and WHO. Acceptability criteria were the ability of the BD Veritor™ System Flu A+B assay (Laboratory Kit) to detect these additional influenza strains.

Analytical Reactivity Testing was conducted as described in section 3, Device Modifications.

BD Veritor™ System Flu A+B assay (Laboratory Kit) was successful in detecting all strains tested. The acceptance criteria were fully met. The package insert will be updated to include the data obtained during this strain reactivity testing. The results of the strain reactivity testing reduced the probability of occurrence from P-3 to P-1 and reduced the Risk Index to the "Insignificant" category:

|  Risk Control Measure | Risk Control Measure Effectiveness Reference | Probability of Severity | Probability of Occurrence | Risk Index  |
| --- | --- | --- | --- | --- |
|  Testing Obtain and test additional flu strains Labeling Update PI with | SDSP15001 | S-3 | P-1 | GR  |

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|  new reactivity
after FDA
special 510(k)
clearance |  |  |  |   |
| --- | --- | --- | --- | --- |

c) Declaration of Conformity with Design Controls

A “Declaration of Conformity with Design Controls” statement was submitted for the validation activities and manufacturing facility by the Director of Regulatory Fairs and Quality Systems. The statement indicates that;

1) To the best of knowledge of the Director of Regulatory Fairs and Quality Systems, the verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.

2) The manufacturing facility, BD Rapid Diagnostics Co Ltd, is in conformance with the design control requirements as specified in 21 CFR 820. 30 and the records are available for review.

7. A Truthful and Accurate Statement, a 510(k) Summary, and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter’s description of the particular modification and the analytical strain reactivity data demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K151301](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K151301)

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