(80 days)
Not Found
No
The device description mentions "specific algorithms" used by the reader to interpret results, but there is no mention of AI, ML, or any learning or adaptive capabilities. The algorithms appear to be fixed for interpreting the reflectance-based measurements.
No.
The device is a diagnostic tool for detecting influenza A and B viral antigens. It aids in diagnosis but does not provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The test is to be used as an aid in the diagnosis of influenza A and B viral infections."
No
The device description explicitly states it includes a "portable electronic device which uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip". This is a hardware component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasopharyngeal wash/aspirate and swab samples... from symptomatic patients." This describes a test performed in vitro (outside the body) on a biological sample to aid in diagnosis.
- Device Description: The description details a "chromatographic assay" that detects viral antigens in "samples processed from respiratory specimens." This further confirms the in vitro nature of the test.
- Performance Studies: The document includes detailed performance studies (Analytical Sensitivity, Analytical Specificity, Cross Reactivity, Clinical Performance) which are standard for evaluating the performance of an IVD.
- Predicate Device: The mention of "Predicate Device(s)" with K numbers (which are FDA clearance numbers for medical devices, including IVDs) strongly indicates that this device is also intended to be an IVD and is being compared to previously cleared IVDs.
N/A
Intended Use / 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 samples in transport media 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) wash/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 February 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.
Product codes (comma separated list FDA assigned to the subject device)
GNX
Device Description
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 antigens bind to antiinfluenza antibodies conjugated to detector particles on the A+B test strip. The antigenconjugate 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal wash/aspirate and swab samples
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Analytical Specificity:
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 microorganisms (36 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-thecounter (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 present in patient respiratory samples. None of the substances evaluated were shown to interfere with the performance of the test.
Media Compatibility:
Ten different types of transport media commonly used for the preservation and transport of respiratory specimens were evaluated for compatibility with the BD Veritor™ System for Rapid Detection of Flu A+B test. The effects of frozen storage of transport media samples on the stability of the antigen were also evaluated in this study.
Reproducibility:
The reproducibility of the BD Veritor System for Rapid Detection of Flu A+B test was evaluated at three clinical laboratory 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.
Clinical Performance NP Swab in Transport Media 2011-2012; U.S. and Japan Combined:
Performance characteristics for the BD Veritor System for Rapid Detection of Flu A+B test were established using NP swabs in transport media in multi-center studies conducted at six clinical trial sites located in geographically diverse areas within the United States and five clinical sites in Japan using a total of 292 samples.
For Flu A: PPA: 81.3% (70.0%, 88.9%), NPA: 97.4% (94.4%, 98.8%)
For Flu B: PPA: 85.6% (76.8%, 91.4%), NPA: 99.0% (96.5%, 99.7%)
Clinical Performance NP Swab in Transport Media 2011-2012; U.S:
A total of 217 prospective specimens were evaluated using the BD Veritor System for Rapid Detection of Fly A+B test and PCR.
For Flu A: PPA: 81.3% (95% CI: 70.0%, 88.9%), NPA: 96.6% (95% CI: 90.8%, 98.0%)
For Flu B: PPA: 77.8% (95% CI: 45.3%, 93.7%), NPA: 100% (95% CI: 98.0%, 100%)
Clinical Performance NP Swab in Transport Media 2011-2012; Japan:
A total of 93 prospective specimens were evaluated using the BD Veritor System for Rapid Detection of Flu A+B test and PCR.
For Flu A: No Data for PPA Calculation, NPA: 100% (95% Cl: 95.9%, 100%)
For Flu B: PPA: 86.4% (95% CI: 77.3%, 92.2%), NPA: 80.0% (95% Cl: 49.0%, 94.3%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics reported are Percent Positive Agreement (PPA) and Percent Negative Agreement (NPA).
Reproducibility Results - Percent of Flu A Positives:
- High negative H1N1 A: Site 1: 3.3% (1/30), Site 2: 0.0% (0/30), Site 3: 0.0% (0/30), Total: 1.1% (1/90)
- Low positive H1N1 A: Site 1: 93.3% (28/30), Site 2: 86.7% (26/30), Site 3: 93.3% (28/30), Total: 91.1% (82/90)
- Moderate positive H1N1 A: Site 1: 100.0% (30/30), Site 2: 96.7% (29/30), Site 3: 100.0% (30/30), Total: 98.9% (89/90)
- High negative H3N2 A: Site 1: 16.7% (5/30), Site 2: 3.3% (1/30), Site 3: 0.0% (0/30), Total: 6.7% (6/90)
- Low positive H3N2 A: Site 1: 93.3% (28/30), Site 2: 86.7% (26/30), Site 3: 93.3% (28/30), Total: 91.1% (82/90)
- Moderate positive H3N2 A: Site 1: 100.0% (30/30), Site 2: 100.0% (30/30), Site 3: 96.7% (29/30), Total: 98.9% (89/90)
- Flu A Negatives: Site 1: 0.8% (1/120), Site 2: 0.0% (0/120), Site 3: 0.0% (0/119), Total: 0.3% (1/359)
Reproducibility Results - Percent of Flu B Positives:
- High negative B: Site 1: 3.3% (1/30), Site 2: 0.0% (0/30), Site 3: 0.0% (0/30), Total: 1.1% (1/90)
- Low positive B: Site 1: 90.0% (27/30), Site 2: 63.3% (19/30), Site 3: 82.8% (24/29), Total: 78.7% (70/89)
- Moderate positive B: Site 1: 96.7% (29/30), Site 2: 100.0% (30/30), Site 3: 100.0% (30/30), Total: 98.9% (89/90)
- Flu B Negatives: Site 1: 0.0% (0/210), Site 2: 0.0% (0/210), Site 3: 0.0% (0/210), Total: 0.0% (0/630)
Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for NP swab in Transport Media-U.S. and Japan Combined:
- BD Flu A:
- PPA: 81.3% (70.0%, 88.9%)
- NPA: 97.4% (94.4%, 98.8%)
- BD Flu B:
- PPA: 85.6% (76.8%, 91.4%)
- NPA: 99.0% (96.5%, 99.7%)
Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for NP Swab in Transport Media Specimens – U. S.:
- BD Flu A:
- PPA: 81.3% (95% CI: 70.0%, 88.9%)
- NPA: 96.6% (95% CI: 90.8%, 98.0%)
- BD Flu B:
- PPA: 77.8% (95% CI: 45.3%, 93.7%)
- NPA: 100% (95% CI: 98.0%, 100%)
Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for NP Swab in transport media specimens - Japan:
- BD Flu A:
- No Data for PPA Calculation
- NPA: 100% (95% Cl: 95.9%, 100%)
- BD Flu B:
- PPA: 86.4% (95% CI: 77.3%, 92.2%)
- NPA: 80.0% (95% Cl: 49.0%, 94.3%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Quidel QuickVue Influenza A+B (K053146 and K092698)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3328 Influenza virus antigen detection test system.
(a)
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.(b)
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.
0
510(k) SUMMARY
SEP 7 2012
SUBMITTED BY: BECTON, DICKINSON AND COMPANY 10865 Road to the Cure. Suite 200 San Diego, CA 92121 Phone: 858-795-7890 Fax: 858-812-8505
CONTACT NAME: Gregory Payne
DATE PREPARED: September 5, 2012
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 immunoassav for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasopharyngeal wash/aspirate and swab samples in transport media 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) wash/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 February 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
1
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 DESCRIPTION:
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 antigens bind to antiinfluenza antibodies conjugated to detector particles on the A+B test strip. The antigenconjugate 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.
2
DEVICE COMPARISON:
.
The BD Veritor™ System for Rapid Detection of Flu A+B was compared to the Quidel QuickVue Influenza A+B test (K053146 and K092698).
.
| Product Feature | BD Veritor™ System for Flu A+B | Quidel QuickVue Influenza A+B (K053146) |
|---|---|---|
| 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 | ||
| samples in transport media 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) wash/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 February 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. | The QuickVue® Influenza A+B test allows for the rapid,
qualitative detection of influenza type A and type B
antigens directly from nasal swab, nasopharyngeal swab,
nasal aspirate, and nasal wash specimens. The test is
intended for use as an aid in the rapid differential
diagnosis of acute influenza type A and type B viral
infections. The test is not intended to detect influenza C
antigens. Negative results should be confirmed by cell culture; they do not preclude influenza virus infection and
should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. |
| Specimen Types | Nasopharyngeal wash/aspirates and nasopharyngeal swabs
in transport media | Nasal swab, nasopharyngeal swab, nasal wash/aspirate |
| Assay Technology | Immunochromatographic | Immunochromatographic |
| 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 the scoring algorithm, and reports
a positive, negative, or invalid result on the LCD screen
based on pre-set thresholds. | Visual determination of presence or absence of pink-to-
red Test Line and the appearance of a blue Procedural
Control Line on the test strip indicate the presence of
influenza A and/or B antigen. |
| Total Assay Time | Approximately 10 minutes | 10 minutes |
| Control format | Kit Flu A+/B- dry swab procedural control Kit Flu B+/A- dry swab procedural control Internal positive control Internal negative control | Kit Flu A+ control swab Kit Flu B+ control swab Kit Negative control swab Internal control lines |
| Detection of Flu A
and B viruses | Differentiated influenza A and influenza B | Differentiated influenza A and influenza B |
3
Summary of Performance Data from K120049:
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
LOD
(TCID50/mL) | No.
Positive
/ Total | %
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
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 microorganisms (36 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
4
A variety of substances including whole blood, prescription medications and over-thecounter (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 present in patient respiratory samples. None of the substances evaluated were shown to interfere with the performance of the test.
Media Compatibility
Ten different types of transport media commonly used for the preservation and transport of respiratory specimens were evaluated for compatibility with the BD Veritor™ System for Rapid Detection of Flu A+B test. The effects of frozen storage of transport media samples on the stability of the antigen were also evaluated in this study.
Reproducibility
The reproducibility of the BD Veritor System for Rapid Detection of Flu A+B test was evaluated at three clinical laboratory 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 | Site 1 | Site 2 | Site 3 | Total |
| High negative H1N1 A | 3.3% (1/30) | |||
| (0.6%,16.7%) | 0.0% (0/30) | |||
| (0.0%,11.3%) | 0.0% (0/30) | |||
| (0.0%,11.3%) | 1.1% (1/90) | |||
| (0.2%,6.0%) | ||||
| Low positive H1N1 A | 93.3% (28/30) | |||
| (78.7%,98.2%) | 86.7% (26/30) | |||
| (70.3%,94.7%) | 93.3% (28/30) | |||
| (78.7%,98.2%) | 91.1% (82/90) | |||
| (83.4%,95.4%) | ||||
| Moderate positive H1N1 A | 100.0% (30/30) | |||
| (88.6%,100.0%) | 96.7% (29/30) | |||
| (83.3%,99.4%) | 100.0% (30/30) | |||
| (88.6%,100.0%) | 98.9% (89/90) | |||
| (94.0%,99.8%) | ||||
| High negative H3N2 A | 16.7% (5/30) | |||
| (7.3%,33.6%) | 3.3% (1/30) | |||
| (0.6%,16.7%) | 0.0% (0/30) | |||
| (0.0%,11.3%) | 6.7% (6/90) | |||
| (3.1%,13.8%) | ||||
| Low positive H3N2 A | 93.3% (28/30) | |||
| (78.7%,98.2%) | 86.7% (26/30) | |||
| (70.3%,94.7%) | 93.3% (28/30) | |||
| (78.7%,98.2%) | 91.1% (82/90) | |||
| (83.4%,95.4%) | ||||
| Moderate positive H3N2 A | 100.0% (30/30) | |||
| (88.6%,100.0%) | 100.0% (30/30) | |||
| (88.6%,100.0%) | 96.7% (29/30) | |||
| (83.3%,99.4%) | 98.9% (89/90) | |||
| (94.0%,99.8%) | ||||
| Flu A Negatives | 0.8% (1/120) | |||
| (0.1%,4.6%) | 0.0% (0/120) | |||
| (0.0%,3.1%) | 0.0% (0/119) | |||
| (0.0%,3.1%) | 0.3% (1/359) | |||
| (0.0%,1.6%) |
| Reproducibility Results – Percent of Flu B Positives | ||||
|---|---|---|---|---|
| Sample | Site 1 | Site 2 | Site 3 | Total |
| High negative B | 3.3% (1/30) | |||
| (0.6%,16.7%) | 0.0% (0/30) | |||
| (0.0%,11.3%) | 0.0% (0/30) | |||
| (0.0%,11.3%) | 1.1% (1/90) | |||
| (0.2%,6.0%) | ||||
| Low positive B | 90.0% (27/30) | |||
| (74.4%,96.5%) | 63.3% (19/30) | |||
| (45.5%,78.1%) | 82.8% (24/29) | |||
| (65.5%,92.4%) | 78.7% (70/89) | |||
| (69.0%,85.9%) |
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| Reproducibility Results – Percent of Flu B Positives | ||||
|---|---|---|---|---|
| Sample | Site 1 | Site 2 | Site 3 | Total |
| Moderate | 96.7% (29/30) | 100.0% (30/30) | 100.0% (30/30) | 98.9% (89/90) |
| positive B | (83.3%,99.4%) | (88.6%, 100.0%) | (88.6%.100.0%) | (94.0%,99.8%) |
| Flu B Negatives | 0.0% (0/210) | 0.0% (0/210) | 0.0% (0/210) | 0.0% (0/630) |
| (0%,1.8.0%) | (0.0%,1.8%) | (0.0%,1.8%) | (0.0%,0.6%) |
Clinical Performance Data for NP Swabs in Transport Media 2011-2012
EXPECTED VALUES
The rate of positivity observed in respiratory testing will vary depending on the method of specimen collection, handling/transport system employed, detection method utilized, the time of year, age of the patient, geographic location and most importantly, local disease prevalence. The overall prevalence observed with an FDA-cleared influenza A and B molecular assay in the U.S. during the 2011-2012 clinical study was 31.7% for influenza A and 4.5% for influenza B. At the clinical sites located in Japan, the prevalence observed with the same FDA-cleared influenza A and B molecular assay was 0% for influenza A and 89 % for influenza B.
Clinical Performance NP Swab in Transport Media 2011-2012; U.S. and Japan Combined
Performance characteristics for the BD Veritor System for Rapid Detection of Flu A+B test were established using NP swabs in transport media in multi-center studies conducted at six clinical trial sites located in geographically diverse areas within the United States and five clinical sites in Japan using a total of 292 samples.
The combined results are presented in the Table below.
Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for NP swab in Transport Media-U.S. and Japan Combined
| BD Flu A | Reference PCR | Total | BD Flu B | Reference PCR | Total | ||
|---|---|---|---|---|---|---|---|
| P | N | P | N | ||||
| P | 52 | 6 | 58 | P | 77 | 2 | 79 |
| N | 12 | 222 | 234 | N | 13 | 200 | 213 |
| Total | 64 | 228 | 292 | Total | 90 | 202 | 292 |
| Reference Method: PCR | |||||||
| PPA: 81.3% (70.0%, 88.9%) | |||||||
| NPA: 97.4% (94.4%, 98.8%) | Reference Method: PCR | ||||||
| PPA: 85.6% (76.8%, 91.4%) | |||||||
| NPA: 99.0% (96.5%, 99.7%) |
Clinical Performance NP Swab in Transport Media 2011-2012; U.S
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Performance characteristics for the BD Veritor System for Rapid Detection of Flu A+B test were established using NP swabs in transport media in multi-center studies conducted at six clinical trial sites located in geographically diverse areas within the United States. A total of 217 prospective specimens were evaluated using the BD Veritor System for Rapid Detection of Fly A+B test and PCR. Two specimens could not be evaluated because of data reconciliation issues, one was eliminated because of an invalid control reading and 13 were excluded because the PCR results were unresolved.
The specimens consisted of NP Swab in transport media from symptomatic patients. 55.8% of the samples were from females and 44.2% from males. 16.1% were from patients less than or equal to 5 years of age, 25.3% were from patients 6-21 years of age, 47.5% were from patients 22-59 years of age and 11.1% were obtained from patients greater than or equal to 60 years of age.
The performance of the BD Veritor System for Rapid Detection of Flu A+B test was compared to an FDA-cleared Influenza A and B molecular assay (PCR).
The results are represented in the Table below.
| Summary of the Performance of the BD Veritor System for Rapid Detection of Flu |
|---|
| A+B Test Compared to PCR for NP Swab in Transport Media Specimens – U. S. |
| Clinical kit: | Reference PCR | Total | |
|---|---|---|---|
| BD Flu A | P | N | |
| P | 52 | 6 | 58 |
| N | 12 | 131 | 143 |
| Total | 64 | 137 | 201 |
| Reference Method: Reference PCR | |||
| PPA: 81.3% (95% CI: 70.0%, 88.9%) | |||
| NPA: 96.6% (95% CI: 90.8%, 98.0%) | |||
| Clinical kit: | |||
| BD Flu B | Reference PCR | Total | |
| P | N | ||
| P | 7 | 0 | 7 |
| N | 2 | 192 | 194 |
| Total | 9 | 192 | 201. |
| Reference Method: Reference PCR | |||
| PPA: 77.8% (95% CI: 45.3%, 93.7%) | |||
| NPA: 100% (95% CI: 98.0%, 100%) |
Clinical Performance NP Swab in Transport Media 2011-2012; Japan
Performance characteristics for the BD Veritor System for Rapid Detection of Flu A+B test were established using NP swabs in transport media in multi-center studies conducted at five clinical trial sites in Japan. A total of 93 prospective specimens were evaluated using the BD Veritor System for Rapid Detection of Flu A+B test and PCR. Two specimens were excluded as the results were undetermined with the comparator assay.
The specimens consisted of NP Swab in transport media from symptomatic patients. 49.5% of the samples were from females and 50.5% from males. 31.2% were from patients less than or equal to 5 years of age, 63.4% were from patients 6-21 years of age and 5.4% were from patients 22-59 years of age BD Diagnostic Systems Page 11 Becton, Dickinson and Company
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(there were no specimens from patients greater than or equal to 60 years of age). . .
The results are represented in the Table below.
Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for NP Swab in transport media specimens - Japan.
| Clinical kit: | Reference PCR | Total | |
|---|---|---|---|
| BD Flu A | P | N | |
| P | 0 | 0 | 0 |
| N | 0 | 91 | 91 |
| Total | 0 | 91 | 91 |
| Clinical kit: | |||
| BD Flu B | Reference PCR | Total | |
| P | N | ||
| P | 70 | 2 | 72 |
| N | 11 | 8 | 19 |
| Total | 81 | 10 | 91 |
Reference Method: Reference PCR No Data for PPA Calculation . NPA: 100% (95% Cl: 95.9%, 100%)
Reference Method: Reference PCR PPA: 86.4% (95% CI: 77.3%, 92.2%) NPA: 80.0% (95% Cl: 49.0%, 94.3%)
BD Diagnostic Systems Becton, Dickinson and Company
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
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
SEP 7 2012
K121797 Re:
Trade Name: BD Veritor" System for Rapid Detection of Flu A+B Regulation Number: 21 CFR §866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: Class I Product Codes: GNX Dated: June 15, 2012 Received: June 19, 2012
、
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 i 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 either class II (Special Controls) or class III (PMA), 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).
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Page 2 - Gregory P. Payne
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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/ReportaProblem/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 (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Uve Safra
Sally A. Hojvat, 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: K121797
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 wash/aspirate and swab samples in transport media 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) wash/aspirates were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and BY amagata 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 February 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.
Over-the-Counter Use AND/OR Prescription Use V (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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)
Uve Schf
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
k 12 1797 510(k)
BD Diagnostic Systems Becton, Dickinson and Company Page 4