BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B

K112277 · Becton, Dickinson and Company · PSZ · Oct 28, 2011 · Microbiology

Device Facts

• Record ID: K112277
• Device Name: BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
• Applicant: Becton, Dickinson and Company
• Product Code: PSZ · Microbiology
• Decision Date: Oct 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3328
• Device Class: Class 2

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 and nasal swabs of 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. 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

The BD Veritor System is a point-of-care diagnostic tool for influenza A and B. It utilizes a chromatographic immunoassay where processed respiratory samples are applied to a test strip; influenza antigens bind to antibody-conjugated detector particles; the complex migrates to a reaction area for capture by an antibody line. A portable electronic reader performs reflectance-based measurement of line signal intensities on the strip. The reader applies algorithms to evaluate these intensities against pre-set thresholds to determine the presence or absence of analytes. Results are displayed on an LCD screen for the operator. This system aids clinicians in rapid diagnosis, allowing for immediate patient management decisions, though negative results are presumptive and require molecular or culture confirmation.

Clinical Evidence

Multi-center POC study (5 U.S. sites, 8 Japan sites) with 736 prospective nasopharyngeal and nasal swab specimens. Compared against FDA-cleared molecular PCR assays. U.S. PPA: 78.7% (Flu A), 74.3% (Flu B); NPA: 97.8% (Flu A), 99.5% (Flu B). Japan PPA: 94.4% (Flu A), 91.4% (Flu B); NPA: 96.7% (Flu A), 94.7% (Flu B). Reproducibility evaluated at 3 POC sites using 30 simulated samples.

Technological Characteristics

Immunochromatographic assay; portable electronic reader; reflectance-based measurement; LCD output. Uses internal positive/negative controls and external dry swab procedural controls.

Indications for Use

Indicated for symptomatic patients requiring rapid, qualitative, differentiated detection of influenza A and B viral nucleoprotein antigens from nasopharyngeal and nasal 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

• Quidel QuickVue Influenza A+B (K053146)
• Quidel QuickVue Influenza A+B (K092698)

Submission Summary (Full Text)

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BD Veritor 100 System for Rapid Detection of Flu A+B Point of Care

CONFIDENTIAL AND PROPRIET

OCT 2 8 2011

#### 510(k) SUMMARY

| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY<br>11085 North Torrey Pines Road, Suite 210<br>La Jolla, CA 92037<br>Phone: [phone]<br>Fax: [phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Gregory Payne |
| DATE PREPARED: | October 25, 2011 |
| DEVICE TRADE NAME: | BD Veritor™ System for Rapid Detection of Flu A+B |
| DEVICE COMMON NAME: | Influenza virus serological reagents |
| DEVICE CLASSIFICATION: | 21 CFR § 866.3330 |
| PREDICATE DEVICES: | Quidel QuickVue Influenza A+B |

#### 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 and nasal swabs of 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. 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 DESCRIPTION:

BD Diagnostic Systems Becton, Dickinson and Company

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The BD Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in samples processed from respiratory specimens. The processed specimen is added to the test device where influenza A or influenza B viral anti-influenza antibodies conjugated to detector particles on the A+B test strip. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. Results are interpreted by the BD Veritor™ System Reader, a portable electronic device which uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip, and applies specific algorithms to determine the presence or absence of any target analyte(s). A liquid crystal display (LCD) on the instrument communicates the results to the operator.

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# DEVICE COMPARISON:

The BD Veritor™ System for Rapid Detection of Flu A+B was compared to the QuickVue Influenza A+B test (K053146 and K092698).

| Product Feature | BD Veritor™ System for Flu A+B (k112277) | Quidel QuickVue Influenza A+B (k053146) |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD Veritor™ System for Rapid Detection of<br>Flu A+B is a rapid chromatographic<br>immunoassay for the direct and qualitative<br>detection of influenza A and B viral nucleoprotein<br>antigens from nasopharyngeal and nasal swabs<br>of symptomatic patients. The BD Veritor System<br>for Rapid Detection of Flu A+B is a differentiated<br>test, such that influenza A viral antigens can be<br>distinguished from influenza B viral antigens from<br>a single processed sample using a single device.<br>The test is to be used as an aid in the diagnosis<br>of influenza A and B viral infections. A negative<br>test is presumptive and it is recommended that<br>these results be confirmed by viral culture or an<br>FDA-cleared influenza A and B molecular assay.<br>Negative test results do not preclude influenza<br>viral infection and should not be used as the sole<br>basis for treatment or other patient management<br>decisions. The test is not intended to detect<br>influenza C antigens.<br><br>Performance characteristics for influenza A and<br>B were established during January through<br>March of 2011 when influenza viruses A/2009<br>H1N1, A/H3N2, B/Victoria lineage, and<br>B/Yamagata lineage were the predominant<br>influenza viruses in circulation according to the<br>Morbidity and Mortality Weekly Report from the<br>CDC entitled "Update: Influenza Activity-United<br>States, 2010-2011 Season, and Composition of<br>the 2011-2012 Influenza Vaccine." Performance<br>characteristics may vary against other emerging<br>influenza viruses.<br><br>If infection with a novel influenza virus is<br>suspected based on current clinical and<br>epidemiological screening criteria recommended<br>by public health authorities, specimens should be<br>collected with appropriate infection control<br>precautions for novel virulent influenza viruses<br>and sent to the state or local health department<br>for testing. Virus culture should not be attempted<br>in these cases unless a BSL 3+ facility is<br>available to receive and culture specimens. | The QuickVue® Influenza A+B test allows for<br>the rapid, qualitative detection of influenza<br>type A and type B antigens directly from nasal<br>swab, nasopharyngeal swab, nasal aspirate,<br>and nasal wash specimens. The test is<br>intended for use as an aid in the rapid<br>differential diagnosis of acute influenza type A<br>and type B viral infections. The test is not<br>intended to detect influenza C antigens.<br>Negative results should be confirmed by cell<br>culture; they do not preclude influenza virus<br>infection and should not be used as the sole<br>basis for treatment or other management<br>decisions. The test is intended for professional<br>and laboratory use. |
| Specimen<br>Types | Nasopharyngeal and nasal swabs | Nasal swab, nasopharyngeal swab, nasal<br>wash/aspirate |
| Assay<br>Technology | Immunochromatographic | Immunochromatographic |
| Detection<br>Format | An opto-electronic reader determines the line<br>intensity at each of the spatially-defined test and<br>control line positions, interprets the results using<br>the scoring algorithm, and reports a positive,<br>negative, or invalid result on the LCD screen<br>based on pre-set thresholds. | Visual determination of presence or absence<br>of pink-to-red Test Line and the appearance of<br>a blue Procedural Control Line on the test strip<br>indicate the presence of influenza A and/or B<br>antigen. |
| Qualitative | Yes | Yes |
| Total Assay<br>Time | Approximately 10 minutes | Less than 15 minutes |
| Control format | • Kit Flu A+/B- dry swab procedural control<br>• Kit Flu B+/A- dry swab procedural control<br>• Internal positive control<br>• Internal negative control | • Kit Flu A+ control swab<br>• Kit Flu B+ control swab<br>• Kit Negative control swab<br>• Internal control lines |
| Detection of<br>Flu A and B<br>viruses | Differentiated influenza A and influenza B | Differentiated influenza A and influenza B |

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# SUMMARY OF PERFORMANCE DATA:

## Analytical Sensitivity

The limit of detection (LOD) for the BD Veritor System for Rapid Detection of Flu A+B test was established for a total of 7 influenza strains: 4 influenza A and 3 influenza B. The LOD for each strain represents the lowest concentration producing

a positivity rate of approximately 95% based on testing 20 to 60 replicates.

| Type | Influenza Viral Strain | Calculated<br>LOD<br>(TCID50/mL) | No.<br>Positive<br>/ Total | %<br>Positive |
|------|--------------------------|----------------------------------|----------------------------|---------------|
| A | A/Brisbane/10/2007 H3N2 | $7.27 x 10^2$ | 57/60 | 95% |
| A | A/Brisbane/59/2007 H1N1 | $3.30 x 10^2$ | 57/60 | 95% |
| A | A/California/7/2009 H1N1 | $5.00 x 10^3$ | 57/60 | 95% |
| A | A/Victoria/3/75 H3N2 | $3.11 x 10^3$ | 59/60 | 98.3% |
| B | B/Brisbane/60/2008 | $7.42 x 10^3$ | 58/60 | 96.7% |
| B | B/Florida/4/2006 | $1.30 x 10^3$ | 58/60 | 96.7% |
| B | B/Lee/40 | $4.44 x 10^4$ | 20/20 | 100% |

TCID50/mL = 50% Tissue Culture Infectious Dose

# Analytical Specificity

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A panel of 52 influenza viral strains including 20 Influenza A strains and 32 Influenza B strains were evaluated in triplicate with the BD Veritor ™ System for Rapid Detection of Flu A+B test. All Influenza A viruses and all Influenza B viruses were correctly detected by the test.

## Cross Reactivity

A total of 51 microorqanisms (37 bacteria, one yeast and 14 viruses) were tested in triplicate with the BD Veritor™ System for Rapid Detection of Flu A+B test. None of the microorganisms tested were shown to be cross reactive with the test.

#### Interfering Substances

A variety of substances including whole blood, prescription medications and over-the-counter (OTC) medications, were tested with the BD Veritor™ System for Rapid Detection of Flu A+B test in triplicate at concentration levels comparable to or greater than levels that may be resent in patient respiratory samples. None of the substances evaluated were shown to interfere with the performance of the test.

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# CLINICAL STUDIES

## Reproducibility

The reproducibility of the BD Veritor System for Rapid Detection of Flu A+B test was evaluated at three POC sites. The reproducibility panel was composed of 30 simulated influenza A or B samples. These included moderate positive samples, low positive samples (near the assay limit of detection), high negative samples (i.e., containing very low concentrations of virus such that positive results occur ~5% of the time) and negative samples. The results are summarized below.

| Reproducibility Results - Percent of Flu A Positives | | | | |
|------------------------------------------------------|---------------------------------|---------------------------------|---------------------------------|---------------------------------|
| Sample | P1 | P4 | P5 | Total |
| High negative<br>H1N1 A | 0% (0/30)<br>(0%, 11.3%) | 10% (3/30)<br>(3.5%, 25.6%) | 26.7% (8/30)<br>(14.2%, 44.4%) | 12.2% (11/90)<br>(7%, 20.6%) |
| Low positive<br>H1N1 A | 86.7% (26/30)<br>(70.3%, 94.7%) | 96.7% (29/30)<br>(83.3%, 99.4%) | 100% (30/30)<br>(88.6%, 100%) | 94.4% (85/90)<br>(87.6%, 97.6%) |
| Moderate<br>positive H1N1 A | 100% (30/30)<br>(88.6%, 100%) | 100% (30/30)<br>(88.6%, 100%) | 100% (30/30)<br>(88.6%, 100%) | 100% (90/90)<br>(95.9%, 100%) |
| High negative<br>H3N2 A | 0% (0/30)<br>(0%, 11.3%) | 10% (3/30)<br>(3.5%, 25.6%) | 16.7% (5/30)<br>(7.3%, 33.6%) | 8.9% (8/90)<br>(4.6%, 16.6%) |
| Low positive<br>H3N2 A | 100% (30/30)<br>(88.6%, 100%) | 93.3% (28/30)<br>(78.7%, 98.2%) | 96.7% (29/30)<br>(83.3%, 99.4%) | 96.7% (87/90)<br>(90.7%, 98.9%) |
| Moderate<br>positive H3N2 A | 100% (30/30)<br>(88.6%, 100%) | 100% (30/30)<br>(88.6%, 100%) | 100% (30/30)<br>(88.6%, 100%) | 100% (90/90)<br>(95.9%, 100%) |
| Negatives | 0% (0/119)<br>(0%, 3.1%) | 0.8% (1/119)<br>(0.1%, 4.6%) | 0% (0/119)<br>(0%, 3.1%) | 0.3% (1/357)<br>(0%, 1.6%) |

| Reproducibility Results - Percent of Flu B Positives | | | | |
|------------------------------------------------------|---------------------------------|-------------------------------|--------------------------------|---------------------------------|
| Sample | P1 | P4 | P5 | Total |
| High negative<br>B | 0% (0/30)<br>(0%, 11.3%) | 3.3% (1/30)<br>(0.6%, 16.7%) | 26.7% (8/30)<br>(14.2%, 44.4%) | 10% (9/90)<br>(5.4%, 17.9%) |
| Low positive B | 73.3% (22/30)<br>(55.6%, 85.8%) | 90% (27/30)<br>(74.4%, 96.5%) | 90% (27/30)<br>(74.4%, 96.5%) | 84.4% (76/90)<br>(75.6%, 90.5%) |

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| Reproducibility Results - Percent of Flu B Positives | | | | |
|------------------------------------------------------|-------------------------------|---------------------------------|-------------------------------|---------------------------------|
| Sample | P1 | P4 | P5 | Total |
| Moderate<br>positive B | 100% (29/29)<br>(88.3%, 100%) | 96.6% (28/29)<br>(82.8%, 99.4%) | 100% (29/29)<br>(88.3%, 100%) | 98.9% (86/87)<br>(93.8%, 99.8%) |
| Negatives | 0% (0/210)<br>(0%, 1.8%) | 1.0% (2/210)<br>(0.3%, 3.4%) | 0% (0/210)<br>(0%, 1.8%) | 0.3% (2/630)<br>(0.1%, 1.2%) |

# Clinical Performance .

## Clinical Performance:

Performance characteristics for the BD Veritor System for Rapid Detection of Flu A+B test were established in multi-center Point-of-Care (POC) studies conducted at five U.S. trial sites and eight Japan trial sites during the 2010-2011 respiratory season. A total of 736 prospective specimens (515 in the U.S and 221 in Japan) were evaluated using the BD Veritor System for Rapid Detection of Flu A+B test and PCR. These specimens consisted of nasopharyngeal and nasal swabs from symptomatic patients. In the U.S. 54% of the samples were from females with 46% from males. 20.3% were from patients less than or equal to 5 years of age. 40.8% of the patients tested were in the 6-21 year age group, 35.6% were from 22-59 years of age and the remaining 3.3% were obtained from people greater than or equal to age 60. In Japan, 43.3% of the samples were from females with 56.7% from males. 27.3% of the samples were from patients less than or equal to 5 years of age. 58.4% were from patients in the 16-21 year age group. 13.1% from 22-59 years of age and 1.3% were obtained from people greater than or equal to age 60.

The performance of the BD Veritor System for Rapid Detection of Flu A+B test at the U.S. sites were compared to an FDA cleared Influenza A and B molecular assay and are presented in Table 1 through Table 3.

| Table 1: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B |
|---------------------------------------------------------------------------------------------|
| Test Compared to PCR for All Swabs - U.S. Sites |

| | Reference<br>PCR | | |
|-------------------------------------------------------------|------------------|-----|-------|
| POC:<br>BD Flu<br>A | P | N | Total |
| P | 122 | 8 | 130 |
| N | 33* | 352 | 385 |
| Total | 155 | 360 | 515 |
| Reference Method: PCR<br>PPA: 78.7% (95% C.I. 71.6%, 84.4%) | | | |

NPA: 97.8% (95% C.I. 95.7%, 98.9%)

| | | Reference PCR | | |
|------------------------------------|------|---------------|-------|--|
| POC:<br>BD Flu<br>B | P | N | Total | |
| P | 75 | ನ | 77 | |
| N | 26** | 412 | 438 | |
| Total | 101 | 414 | 515 | |
| Reference Method: PCR | | | | |
| PPA: 74.3% (95% C.I. 65%, 81.8%) | | | | |
| NPA: 99.5% (95% C.I. 98.3%, 99.9%) | | | | |

* Of the 33 PCR positive, BD Veritor negative Influenza A specimens, eight were positive in the BD Veritor assay using a second swab specimen (reference method specimen) collected from the same patient.

BD Diagnostic Systems Becton, Dickinson and Company

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** Of the 26 PCR positive, BD Veritor negative Influenza B specimens, six were positive in the BD Veritor assay using a second swab specimen (reference method spcimen) collected from the same patient.

Table 2: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for Nasopharyngeal Swabs - U.S. Sites

| | Reference<br>PCR | | | |
|-----------------------------------|------------------|-----|-------|--|
| POC:<br>BD Flu A | P | N | Total | |
| P | 53 | 5 | 58 | |
| N | 18 | 135 | 153 | |
| Total | 71 | 140 | 211 | |
| Reference Method: PCR | | | | |
| PPA: 74.6% (95% C.I. 63.4%-83.3%) | | | | |
| NPA: 96.4% (95% C.I. 91.9%-98.5%) | | | | |
| | Reference PCR | | | |
| POC.<br>BD Flu<br>B | P | N | Total | |
| P | 22 | 1 | 23 | |
| N | 8 | 180 | 188 | |
| Total | 30 | 181 | 211 | |
| Reference Method: PCR | | | | |
| PPA: 73.3% (95% C.I. 55.6%-85.8%) | | | | |
| NPA: 99.4% (95% C.I. 96.9%-99.9%) | | | | |

Table 3: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for Nasal Swabs - U.S. Sites

| | Reference<br>PCR | | | |
|------------------------------------|------------------|---------------|-------|--|
| POC:<br>BD Flu<br>A | P | N | Total | |
| p | ലു | 3 | 72 | |
| N | 15 | 217 | 232 | |
| Total | 84 | 220 | 304 | |
| Reference Method: PCR | | | | |
| PPA: 82.1% (95% C.I. 72.6%, 88.9%) | | | | |
| NPA: 98.6% (95% C.I. 96.1%, 99.5%) | | | | |
| | | Reference PCR | | |
| POC:<br>BD Flu<br>B | P | N | Total | |
| P | 53 | 1 | 54 | |
| N | 18 | 232 | 250 | |
| Total | 71 | 233 | 304 | |
| Reference Method: PCR | | | | |
| PPA: 74.6% (95% C.I. 63.4%-83.3%) | | | | |
| NPA: 99.6% (95% C.I. 97.6%-99.9%) | | | | |

The performance of the BD Veritor System for Rapid Detection of Flu A+B test at the Japan sites were also compared to an FDA cleared Influenza A and B molecular assay and are presented in Table 4 through Table 6.

Table 4: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for all Swabs - Japan Sites

| | Reference<br>PCR | | |
|---------------------|------------------|-----|-------|
| POC:<br>BD Flu<br>A | P | N | Total |
| P | 67 | 5 | 72 |
| N | 4 | 145 | 149 |
| Total | 71 | 150 | 221 |
| | Reference PCR | | |
| POC:<br>BD Flu<br>B | P | N | Total |
| P | 64 | 8 | 72 |
| N | 6 | 143 | 149 |
| Total | 70 | 151 | 221 |

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| | Reference<br>PCR | | |
|-------------------------------------------------------------------------------------------------|------------------|---|-------|
| POC:<br>BD Flu<br>A | P | N | Total |
| Reference Method: PCR<br>PPA: 94.4% (95% C.I. 86.4%-97.8%)<br>NPA: 96.7% (95% C.I. 92.4%-98.6%) | | | |
| | Reference PCR | | |
| POC:<br>BD Flu<br>B | P | N | Total |
| Reference Method: PCR | | | |
| PPA: 91.4% (95% C.I. 82.5%-96%) | | | |
| NPA: 94.7% (95% C.I. 89.9%-97.3%) | | | |

Table 5: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for all Nasopharyngeal Swabs - Japan Sites

| | Reference PCR | | |
|-----------------------------------|---------------|----|-------|
| POC:<br>BD Flu<br>A | P | N | Total |
| P | 30 | 1 | 31 |
| N | 2 | 83 | 85 |
| Total | 32 | 84 | 116 |
| Reference Method: PCR | | | |
| PPA: 93.8% (95% C.I. 79.9%-98.3%) | | | |
| NPA: 98.8% (95% C.I. 93.6%-99.8%) | | | |
| | Reference PCR | | |
| POC:<br>BD Flu<br>B | P | N | Total |
| P | 38 | 2 | 40 |
| N | 1 | 75 | 76 |
| Total | 39 | 77 | 116 |
| Reference Method: PCR | | | |
| PPA: 97.4% (95% C.I. 86.8%-99.5%) | | | |
| NPA: 97.4% (95% C.I. 91%-99.3%) | | | |

Table 6: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for Nasal Swabs – Japan Sites

| | Reference PCR | | | | Reference PCR | | |
|-------------------------------------------------------------------------------------------------|---------------|----|-------|-------------------------------------------------------------------------------------------------|---------------|----|-------|
| POC:<br>BD Flu<br>A | P | N | Total | POC:<br>BD Flu<br>B | P | N | Total |
| P | 37 | 4 | 41 | P | 26 | 6 | 32 |
| N | 2 | 62 | 64 | N | 5 | 68 | 73 |
| Total | 39 | 66 | 105 | Total | 31 | 74 | 105 |
| Reference Method: PCR<br>PPA: 94.9% (95% C.I. 83.1%-98.6%)<br>NPA: 93.9% (95% C.I. 85.4%-97.6%) | | | | Reference Method: PCR<br>PPA: 83.9% (95% C.I. 67.4%-92.9%)<br>NPA: 91.9% (95% C.I. 83.4%-96.2%) | | | |

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, flowing design.

10903 New Hampshire Avenue Silver Spring, MD 20993

## OCT 2 8 2011

Becton, Dickinson and Company c/o Gregory P. Payne, RAC Director, Quality Systems and Regulatory Affairs 10865 Road to the Cure, Suite 200 San Diego, CA 92121

Re: K112277

Trade/Device Name: BD Veritor " System for the Rapid Detection of Flu A + B Regulation Number: 21 CFR& 866.3330 Regulation Name: Influenza Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: September 30, 2011 Received: October 3, 2011

Dear Mr. Payne:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Greg Payne

notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. 1

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Uue Scif for

Sally A. Hoivat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number:

## Device Name: BD Veritor™ System for Rapid Detection of Flu A+B

#### 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 and nasal swabs of 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. 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Yauwan Hielddl
Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

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