BD Veritor™ System Flu A+B Assay

K133138 · Becton, Dickinson & CO · PSZ · Nov 13, 2013 · Microbiology

Device Facts

• Record ID: K133138
• Device Name: BD Veritor™ System Flu A+B Assay
• Applicant: Becton, Dickinson & CO
• Product Code: PSZ · Microbiology
• Decision Date: Nov 13, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3328
• Device Class: Class 2
• Attributes: Pediatric

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. 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.” 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 rapid chromatographic immunoassay for influenza A and B detection. The modification allows a single nasopharyngeal specimen (wash, aspirate, or swab in transport media) to be processed once and tested sequentially on both the Flu A+B device and the RSV device. The user dispenses processed sample into the Flu A+B device well, then immediately into the RSV device well. After a 10-minute incubation, the user inserts each device into the BD Veritor System Reader. The reader provides automated results based on the chromatographic test strips. This workflow enables clinicians to obtain results for both influenza and RSV from a single patient sample, aiding in rapid diagnosis and management of respiratory infections.

Clinical Evidence

No new clinical data presented; substantial equivalence based on identical technology and intended use to previously cleared predicates.

Technological Characteristics

Rapid chromatographic immunoassay; utilizes BD Veritor System Reader for result interpretation; specimen types include nasopharyngeal wash, aspirate, and swab in transport media; requires room temperature (15–30°C) reagents and specimens.

Indications for Use

Indicated for symptomatic patients requiring qualitative detection of influenza A and B viral nucleoprotein antigens from nasopharyngeal wash, aspirate, or swab in transport media. Note: RSV testing from the same specimen is restricted to patients < 20 years of age.

Regulatory Classification

Identification

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria: (i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method: (A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent. (B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent. (ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method: (A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent. (B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent. (2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies. (3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria: (i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains. (ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate. (iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by: (A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or (B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access. (4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain: (i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus. (ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by: (A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or (B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.

Predicate Devices

• BD Veritor™ System Flu A+B assay (k120049, k121797, k132256)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification Decision Summary

To: Becton, Dickinson and Company

RE: K133138

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class I 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

510(k) number: k120049, k121797, k132256

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 adding a procedure for using the obtained clinical specimen to run the BD Veritor™ System RSV assay in addition to the Flu A+B assay, both assays will be performed separately, but using a single specimen, nasopharyngeal aspirate/wash or nasopharyngeal swab in transport media. The following text and accompanying diagrams were added to the package insert:

ALTERNATIVE TEST PROCEDURE

USE OF BD VERITOR SYSTEM FOR RAPID DETECTION OF INFLUENZA A+B (CAT# 256041) AND BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV (CAT# 256042) FROM A SINGLE NP WASH, ASPIRATE OR SWAB SPECIMEN IN TRANSPORT MEDIA

USE THIS PROCEDURE IF BOTH INFLUENZA A+B AND RSV ARE TO BE TESTED FROM A SINGLE PATIENT

IMPORTANT NOTE: THE SAMPLE TO BE TESTED IN THE RSV KIT MUST BE FROM A PATIENT LESS THAN 20 YEARS OF AGE AS INDICATED IN THE BD VERITOR RSV CLINICAL KIT PACKAGE INSERT. THE PROCESSED SAMPLE SHOULD BE TESTED WITHIN 15 MINUTES.

NOTES: Reagents, specimens and devices must be at room temperature (15–30°C) for testing. Thoroughly mix all specimens prior to removal of an aliquot for processing. Do not centrifuge specimens.

Note: The BD Veritor System for Rapid Detection of RSV (CAT #256042) is required for this procedure.

1. For each patient specimen and control swab, remove one RV Reagent C tube/tip and one BD Veritor System Flu A+B device and one BD Veritor System RSV from its foil pouch immediately before testing.


2. Label the BD Veritor System devices and one RV Reagent C tube for each specimen and control to be tested.

3. Place the labeled RV Reagent C tube(s) in the designated area of the tube rack.


4. Vortex or thoroughly mix specimen. Do not centrifuge.

5. 2. Remove and discard the cap from the RV Reagent C tube corresponding to the sample to be tested.

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6. Using the transfer pipette, transfer 300 µL of specimen into the RV Reagent C tube. Discard pipette after use.

7. Press the attached tip firmly onto the RV Reagent C tube containing the processed specimen or control (threading/twisting not required).

NOTE: Do not use tips from any other product, including other products from BD or other manufacturers.

8. Vortex or mix thoroughly.

9. Invert the RV Reagent C tube and hold the tube vertically (approximately one inch above the BD Veritor System Flu A+B device sample well). Holding the tube at the ridged area, squeeze gently allowing three (3) drops of the processed sample to be dispensed into the sample well of the appropriately labeled BD Veritor System Flu A+B device.

NOTE: Squeezing the tube too close to the tip may cause leakage.

10. Immediately continue to test for RSV. Invert the RV Reagent C tube and hold the tube vertically (approximately one inch above the BD Veritor System RSV device sample well). Holding the tube at the ridged area, squeeze gently allowing three (3) drops of the processed sample to be dispensed into the sample well of the appropriately labeled BD Veritor System RSV device.

NOTE: Squeezing the tube too close to the tip may cause leakage.

11. After adding the sample, allow the tests to run for 10 minutes before inserting into the reader.

12. When the test is ready, insert the BD Veritor System Flu A+B device into the BD Veritor System Reader. (The BD Veritor System Reader should be powered-on prior to use and will indicate when it is ready for insertion of the BD Veritor System device.)

Follow the reader on-screen prompts to complete the procedure and obtain the test result

13. Immediately after the Flu A+B result is obtained and recorded, insert the BD Veritor System RSV device into the BD Veritor System Reader.

Follow the reader on-screen prompts to complete the procedure and obtain the test result






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4. The FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.
5. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics:

Similarities

| Item | Proposed Device | Proposed Device |
| --- | --- | --- |
| Features | BD Veritor™ System Flu A+B assay | BD Veritor™ System Flu A+B assay |
| 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. 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. | Same. |

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| | 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.” 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. | |
| --- | --- | --- |
| Read Results | BD Veritor™ System Reader | BD Veritor™ System Reader |
| Specimen Types | nasopharyngeal swab in transport media, nasal aspirate, and nasal wash | nasopharyngeal swab in transport media, nasal aspirate, and nasal wash |
| Read Result Time | 10 minutes | 10 minutes |
| External Controls | Test kit contains Positive and Negative Control swabs | Test kit contains Positive and Negative Control swabs |

## Differences

The package insert has been updated to include an additional procedure for using the obtained clinical specimen to run the BD Veritor™ System RSV assay in addition to the Flu A+B assay. Both assays will be performed separately, but using a single nasopharyngeal aspirate/wash or nasopharyngeal swab in transport media.

## 6. Design Control Activities Summary:

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

b) Declaration of Conformity

A “Declaration of Conformity” statement was submitted for the manufacturing facility and validation activities and signed by the Director of Quality Assurance and the Senior Director of Technical Operations respectively. The statements indicate that;

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1. The manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
2. The validation activities, as required by the risk analysis, for the modification were performed by the designated individuals and the results demonstrated that the predetermined acceptance criteria were met.

In conclusion, based on the results of the analytical reactivity testing the modified labeling is truthful and accurate. The changes do not affect the performance of the test and it is therefore substantially equivalent to the current cleared test.

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 comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. On this basis, I recommend the device be determined substantially equivalent to the previously cleared device.