← Product Code [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ) · K223016

# BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016)

_Bd · PSZ · Jan 27, 2023 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K223016

## Device Facts

- **Applicant:** Bd
- **Product Code:** [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ.md)
- **Decision Date:** Jan 27, 2023
- **Decision:** SESE
- **Submission Type:** Traditional
- **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 CLIA waived assay is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. 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 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

System uses lateral flow immunochromatography to detect influenza A and B antigens in nasal/nasopharyngeal swabs. Processed samples added to test cassette; antigen-antibody complexes migrate to reaction membrane. BD Veritor Plus Analyzer, a portable opto-electronic instrument, measures signal intensity via reflectance. Analyzer applies firmware algorithms to determine presence/absence of analytes; results displayed on LCD. Used in laboratory or near-patient settings by healthcare professionals. Modifications include overvoltage protection on trigger board, increased instrument lifetime (10,000 tests), and InfoWifi module for network connectivity/LIS integration. Output aids clinical diagnosis; negative results require molecular confirmation. Benefits include rapid, differentiated detection of influenza strains.

## Clinical Evidence

No new clinical performance studies conducted; modifications to the Analyzer do not impact assay-specific clinical performance. Previous clinical performance established in K180438.

## Technological Characteristics

Lateral flow immunochromatographic assay. Opto-electronic reflectance-based measurement. Powered by rechargeable Li-ion battery. Connectivity via InfoScan, PlusConnect, and InfoWifi modules (WiFi/LIS integration). Analyzer includes overvoltage protection. Instrument lifetime: 10,000 tests, 24 months from first use, 34 months from manufacture.

## 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 CLIA-Waived Kit ([K112277](/device/K112277.md), [K132692](/device/K132692.md), [K151291](/device/K151291.md), [K160161](/device/K160161.md), [K180438](/device/K180438.md))

## Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number

K223016

B Applicant

BD

C Proprietary and Established Names

BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  PSZ | Class II | 21 CFR 866.3328 - Influenza Virus Antigen Detection Test System | MI - Microbiology  |

## II Submission/Device Overview:

A Purpose for Submission:

To establish Substantial Equivalence to a predicate device and to obtain 510(k) clearance following modifications to the previously 510(k)-cleared BD Veritor System for Rapid Detection of Flu A+B.

B Measurand:

Influenza A Nucleoprotein Antigen

Influenza B Nucleoprotein Antigen

C Type of Test:

Lateral flow immunochromatography

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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III Intended Use/Indications for Use:

A Intended Use(s):
See Indications for Use below.

B Indication(s) for Use:
The BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. 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.

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

D Special Instrument Requirements:
The BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit is intended for use with the BD Veritor Plus Analyzer.

IV Device/System Characteristics:

A Device Description:
The BD Veritor System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from

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nasopharyngeal and nasal swabs of symptomatic patients. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. It is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single test device

When specimens are processed and added to the assay test device, any influenza A or B antigens present in the specimen bind to antibodies conjugated to detector reagents in the test strip. The antigen-conjugate complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the reaction membrane. The BD Veritor test devices are designed with spatially distinct reaction zones including:

- a test line position for each target analyte,
- positive and negative control line positions, and
- a background zone

The measurement of the background zone compensates for background reflectance on the test strip, while the onboard negative control zone identifies and compensates for sample-related, nonspecific signal.

The BD Veritor System consists of a dedicated opto-electronic interpretation instrument and immunochromatographic assays for the qualitative detection of antigens from pathogenic organisms in samples processed from respiratory specimens. The assay included in this application is intended for interpretation in both laboratory and near-patient testing environments only with the BD Veritor Plus Analyzer Instrument (“the Analyzer”) and is not interpreted visually.

The Analyzer is a portable, electronic instrument that uses a reflectance-based measurement method to evaluate line signal intensities on the assay test device. It applies assay-specific firmware algorithms to determine the presence or absence of target analyte(s). The Analyzer is powered by a rechargeable Li-ion battery and compact wall transformer, is intended for tabletop or benchtop use, and follows the original BD Veritor instrument model of a calibration-free limited lifetime based on the number of tests performed, the number of days from first use, and/or the maximum shelf life from the date of manufacture. By design, the Analyzer has few external means for user input or output. Operation requires minimal operator interaction to complete testing and to report results. Analyzer workflow procedures depend on the instrument configuration selected by the user. In Analyze Now mode, the instrument evaluates assay test devices after manual timing of their incubation. In Walk Away mode, test devices are inserted immediately after application of the specimen, and timing of assay incubation and analysis is automated. In either case, assay results are provided to the operator on the LCD display screen. Additional result documentation capabilities are possible with the use of a BD Veritor bar code scanning module, which can capture, display and/or integrate barcoded specimen, operator or kit information in the test record. This 510(k) application includes validation of a new accessory module for the Analyzer that enables communication of test results to a facility WiFi network and integration into a secure data depository and then delivery to a facility LIS system.

## B Principle of Operation:

Immunochromatographic separation of influenza A or B antigen-antibody complexes detected via opto-electronic reader.

## C Instrument Description Information:

1. Instrument Name: BD Veritor Plus Analyzer

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2. Specimen Identification:
Specimens ID's may be manually entered or scanned via the barcode scanner.

3. Specimen Sampling and Handling:
Dry swab samples from nasopharyngeal or nasal swabs are manually transferred to test kit reagent tubes for elution and drop-wise addition to the test cassette.

4. Calibration:
Calibration is not recommended.

5. Quality Control:
The test includes a positive control to ensure adequate migration of the reagents through the test membrane to the desired test line locations for the reader. The test also contains a negative control to test for non-specific binding and two background test regions to measure assay background when calculating test line signal strength. Each kit also contains positive control swabs for Influenza A and Influenza B. It is the manufacturer's recommendation that positive controls be run after every new kit lot, a new operator performs the test, a new shipment of test kits is received, and as required by local, state, and federal regulations.

This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.

V Substantial Equivalence Information:

A Predicate Device Name(s):
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

B Predicate 510(k) Number(s):
K180438

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K223016 | K180438  |
| --- | --- | --- |
|  Device Trade Name | BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay (modified) | BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay  |
|  General Device Characteristic Similarities |  |   |

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|  Intended Use/Indications For Use | The BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA cleared influenza A and B molecular assay. 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- | The BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA cleared influenza A and B molecular assay. Outside the U.S., a negative test is presumptive and it is recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA has not cleared this device for use outside of the U.S. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens. Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the  |
| --- | --- | --- |

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|   | 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. | 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.  |
| --- | --- | --- |
|  Specimen Types | Same | NPS and NS  |
|  Assay Technology | Same | Chromatographic Immunoassay  |
|  Detection Format | Same | Opto-electronic reader  |
|  Type of test | Same | Qualitative  |
|  Analyte detection | Same | Detection and differentiation of Influenza A and Influenza B antigens  |
|  Instrument | Same | BD Veritor Plus Analyzer  |
|  Analyzer software | Same | Version 5.70  |
|  Assay positivity algorithm | Same | Original  |
|  Assay cutoff threshold determination | Same | Original  |
|  General Device Characteristic Differences |  |   |
|  Analyzer trigger board | Original plus overvoltage protection | Original  |

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|  Instrument Lifetime | 10,000 Tests
24 months from first use
34 months from date of manufacture | 3,500 Tests
24 months from first use
34 months from date of manufacture  |
| --- | --- | --- |
|  Supplemental modules or software | InfoScan module
PlusConnect software
InfoWifi software | InfoScan module
PlusConnect software  |

VI Standards/Guidance Documents Referenced:

No Standard/Special Control/Guidance Documents were referenced.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

Not applicable. Please refer to Decision Summary K180438.

B Comparison Studies:

Not applicable.

C Clinical Studies:

1. Clinical Sensitivity:

Clinical Sensitivity remains unchanged since K180438. See K180438 for more information.

2. Clinical Specificity:

Clinical Specificity remains unchanged since K180438. See K180438 for more information.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

None.

D Clinical Cut-Off:

The Clinical Cut-Off remains unchanged since K180438. See K180438 for more information.

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E Expected Values/Reference Range:

Expected Values remains unchanged since K180438. See K180438 for more information

F Other Supportive Instrument Performance Characteristics Data:

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K223016](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K223016)

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