← Product Code [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ) · K152874

# BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit (K152874)

_Becton, Dickinson and Co. · PSZ · Oct 27, 2015 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K152874

## Device Facts

- **Applicant:** Becton, Dickinson and Co.
- **Product Code:** [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ.md)
- **Decision Date:** Oct 27, 2015
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.3328
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for 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 prectude 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 nasopharynged (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 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/Y amagata lineage were the predominant influenza viruses in circulation according to the Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2011-2012 Season, and Composition of the 2012-2013 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 qualitative detection of influenza A and B viral nucleoprotein antigens in respiratory specimens; utilizes reaction tube with mucolytic reagent to expose antigens; processed sample applied to test device; antigen-conjugate complexes migrate to reaction area; captured by antibody lines. Device features five spatially-distinct zones: positive control, negative control, Flu A test line, Flu B test line, and background zone. BD Veritor System Reader uses proprietary algorithm to subtract nonspecific signal from negative control zone from Flu A and B test lines; compares resultant signal against pre-selected cutoff to determine positive/negative status. Used in laboratory settings; operated by laboratory personnel. Provides objective interpretation of test results where visual scoring is difficult; aids in diagnosis of influenza A and B infections.

## Clinical Evidence

No new clinical data presented; substantial equivalence based on analytical strain reactivity testing.

## Technological Characteristics

Immunochromatographic assay; utilizes mucolytic reagent for specimen processing. Device includes five zones: positive control, negative control, Flu A test line, Flu B test line, and background zone. Employs proprietary reader-based algorithm for signal processing and interpretation. Connectivity via BD Veritor System Reader.

## 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 A+B Laboratory kit (k120049, k121797, k132256, k132693, k133138, k151301)

## Submission Summary (Full Text)

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>
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SPECIAL 510(k): Device Modification OIR Decision Summary

To: Becton, Dickinson and Company

RE: K152874

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

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

Device Trade Name:
BD Veritor™ System for Rapid Detection of Flu A+B Laboratory Kit

510(k) numbers:
k120049, k121797, k132256, k132693, k133138, k151301

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 and package labeling.

3. The submitter stated that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed, and provided a description of the device MODIFICATIONS made in this 510(k). The purpose of this special 510(k) is to provide additional information to add to the analytical reactivity table in the package insert showing the ability of the device to detect recently circulating influenza strains at the concentrations shown below.

The modification presented in this special 510(k) is the inclusion of one influenza A strain and five influenza B strains to the Strain Reactivity with Influenza A and B Viruses section of the BD Veritor™ System for Rapid Detection of Flu A+B Laboratory Kit Assay package insert. A list of the strains tested is included below.

|  Strain | Final Dilution Factor | Estimated LOD 1  |
| --- | --- | --- |
|  A/California/02/2014 (H3N2) | 4000 | 1.45 x 10² TCID_{50}/mL  |
|  B/Brisbane/33/2008 (Victoria Lineage) | 200 | 2.45 x 10⁵ CEID_{50}/mL  |
|  B/Guangdong-Liwan/1133/2014 (Yamagata Lineage) | 2000 | 9.0 x 10⁵ CEID_{50}/mL  |
|  B/Hong Kong/259/2010 (Victoria Lineage) | 400 | 1.35 x 10⁶ CEID_{50}/mL  |
|  B/Texas/02/2013 (Victoria Lineage) | 4000 | 2.75 x 10⁴ CEID_{50}/mL  |
|  B/Utah/09/2014 (Yamagata Lineage) | 10000 | 6.3 x 10³ CEID_{50}/mL  |

¹Estimated LOD is the lowest concentration of influenza A and B virus strains that can be detected by the BD Veritor™ System Flu A + B Assay in 3/3 replicates.

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Page 2 of 5

The BD Veritor™ System for Rapid Detection of Flu A+B Laboratory Kit Assay package insert has been updated to include this additional analytical reactivity information.

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

|  Product Feature | Currently Marketed Veritor™ System Flu A + B Laboratory Kit (k 151301) | Product Modification  |
| --- | --- | --- |
|  Similarities: |  |   |
|  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 | unchanged  |

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Page 3 of 5

|  Product Feature | Currently Marketed Veritor(TM) System Flu A + B Laboratory Kit (K151301) | Product Modification  |
| --- | --- | --- |
|   | 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." 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. |   |
|  Specimen type | Nasopharyngeal swabs in transport media and nasopharyngeal wash aspirates | unchanged  |
|  Assay technology | Immunochromatographic | unchanged  |
|  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. | unchanged  |
|  Qualitative or Quantitative | Qualitative | unchanged  |
|  Assay run time | approximately 10 minutes | unchanged  |
|  Control format | • Kit Flu A+/B- dry swab procedural control
• Kit Flu A-/B+ dry swab procedural control
• Internal positive control
• Internal negative control | unchanged  |
|  Detection of Flu A and B viruses | differentiation A vs. B | unchanged  |
|  Differences: |  |   |

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Page 4 of 5

|  Product Feature | Currently Marketed Veritor™ System Flu A + B Laboratory Kit (k 151301) | Product Modification  |
| --- | --- | --- |
|  Analytical Strain Reactivity Tables in Labeling (Package Insert) | Current Product Package Insert includes 73 Flu Strains; 36 Flu A and 37 Flu B in the Analytical Strain reactivity tables. | Analytical Strain reactivity tables on pages 60-61 of the proposed Package Insert will contain data regarding 6 additional Influenza strains  |

5. A 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

The Risk Assessment process used was based on a BD Product Risk Management procedure which, according to the sponsor, meets the requirement for risk management as set forth in ISO 14971:2007 and EN ISO 14971:2012.

Using this procedure, the following were estimated and the results are in the table below under 5b:

- The Hazard,
- The Adverse Effect (Harm to Patient),
- The Potential Causes of the Hazard,
- The probability of Hazard Severity and
- The probability of Occurrence

b. Based on the resulting calculated Risk Index, Risk Control Measures were identified, required verification and validation activities were determined, and effectiveness of risk control measures were verified.

The risk assessment identified the need to confirm the BD Veritor™ System's reactivity to new strains forecast for 2015/2016 Influenza Season.

The results of the analysis indicated an initial possible combination of severity and occurrence that fell into S-3/P-3 category. To implement the indicated investigation, Protocol SDSP15004 was developed and approved based on previously accepted FDA submissions regarding strain reactivity. The design of the study is replicated from a previous Special 510(k) submission. The acceptability criterion was the ability of the BD Veritor™ test to detect the additional Flu strains. The BD Veritor™ System Flu A+B assay successfully detected all strains tested. The data to be included in the insert are the actual values obtained during this testing. The results of the strain testing reduced the probability of occurrence from P-3 to P-1 and reduced the risk to the "negligible" category.

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Page 5 of 5

|  Hazard | False Negative |  | Risk Control Measure | Testing  |
| --- | --- | --- | --- | --- |
|  Adverse Effect (Harm) | Effect on patient is that they could be inappropriately treated leading to flu progression |   |   | Obtain and test additional flu strains  |
|  Probability of Severity | S-3 |   |   | Labeling  |
|  Potential Causes of the Hazard | Assay does not detect the predicted strains for 2015/2016Flu Season or other available new and circulating strains |   |   | Update PI with new reactivity after FDA special 510(k) clearance  |
|  Probability of Occurrence | P-3 |   | Risk Control Measure Effectiveness Reference | SDSP15001  |
|  Existing Risk Control Measure | Current strain reactivity has been determined and is provided in the Product Insert |   | Probability of Severity | S-3  |
|  Risk Index | YE |  | Probability of Occurrence | P-1  |
|  Responsibility for Risk Control Measure | R&D |  | Risk Index | GR  |

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(s) and the comparative information between the modified and unmodified devices 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/K152874](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K152874)

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