BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV

K132456 · Becton, Dickinson and Company · GQG · Nov 7, 2013 · Microbiology

Device Facts

• Record ID: K132456
• Device Name: BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
• Applicant: Becton, Dickinson and Company
• Product Code: GQG · Microbiology
• Decision Date: Nov 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3480
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from a direct nasopharyngeal swab from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 6 years. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor™ System Reader.

Device Story

The BD Veritor System for Rapid Detection of RSV is a point-of-care chromatographic immunoassay. It utilizes a nasopharyngeal swab sample processed and applied to a test strip where RSV fusion protein binds to antibody-conjugated detector particles. The complex migrates to a reaction area for capture. The BD Veritor System Reader, a portable electronic device, performs an instrumented read of the test strip using reflectance-based measurement. The reader evaluates line signal intensities at defined positions, applies a scoring algorithm to determine the presence or absence of the analyte, and displays the result (positive, negative, or invalid) on an LCD screen. Used by healthcare professionals in laboratory or clinical settings to aid in the diagnosis of RSV infections. The instrumented read reduces subjectivity compared to visual interpretation, providing objective results to support clinical decision-making and patient management.

Clinical Evidence

Prospective multi-center study (n=523) of pediatric patients <6 years. Compared BD Veritor RSV to viral cell culture and FDA-cleared PCR. Against culture: 91.8% sensitivity (95% CI: 85.9-95.4%), 93.3% specificity (95% CI: 90.4-95.4%). Against PCR: 81.6% PPA (95% CI: 75.2-86.6%), 99.1% NPA (95% CI: 97.5-99.7%). Invalid rate 0.2%.

Technological Characteristics

Lateral flow immunoassay; colloidal-gold particle detection; monoclonal antibodies. Instrumented read via optical reflectance. Dimensions: benchtop reader. Connectivity: standalone. Sterilization: not specified. Software: algorithm-based signal processing. Materials: test strip membrane, detergent-based extraction reagent.

Indications for Use

Indicated for the qualitative detection of RSV fusion protein in direct nasopharyngeal swabs from symptomatic infants and pediatric patients under 6 years of age suspected of viral respiratory infection. Not for use as the sole basis for treatment decisions; negative results are presumptive and require confirmation by culture or molecular assay.

Regulatory Classification

Identification

Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.

Predicate Devices

• Quidel QuickVue® RSV 10 (K101918)

Submission Summary (Full Text)

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BD Veritor "M System for Rapid Detection of RSV Clinical Laboratory Product

#### 510(k) SUMMARY

| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY<br>10865 Road to the Cure, Suite 200<br>San Diego, CA 92121<br>Phone: [phone]<br>Fax: [phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Gregory Payne <span style="float:right;">NOV 0 7 2013</span> |
| DATE PREPARED: | October 23, 2013 |
| DEVICE TRADE NAME: | BD Veritor ^TM System for Rapid Detection of RSV |
| DEVICE COMMON NAME: | Antigens Cf (including Cf Controls) Respiratory Syncytial<br>Virus |
| DEVICE CLASSIFICATION: | 21 CFR § 866.3480 |
| PREDICATE DEVICE: | Quidel QuickVue RSV 10 test |

#### INTENDED USE:

The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from a direct nasopharyngeal swab from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 6 years. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor™ System Reader.

## DEVICE DESCRIPTION:

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

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## DEVICE COMPARISON:

| | The BD Veritor™ System for Rapid Detection of RSV was compared to the Quidel |
|--------------------------------|------------------------------------------------------------------------------|
| QuickVue RSV 10 test (k101918) | |

| Product<br>Feature | BD Veritor™ System for RSV | Quidel QuickView RSV 10 test (k101918) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD Veritor™ System for Rapid Detection of<br>Respiratory Syncytial Virus (RSV) is a<br>chromatographic immunoassay with an<br>instrumented read for the direct and qualitative<br>detection of RSV fusion protein from a direct<br>nasopharyngeal swab from patients suspected of<br>having a viral respiratory infection. This test is<br>intended for in vitro diagnostic use to aid in the<br>diagnosis of RSV infections in infants and<br>pediatric patients under the age of 6 years.<br>Negative results do not preclude RSV infection<br>and should not be used as the sole basis for<br>treatment or for other management decisions. A<br>negative test is presumptive. It is recommended<br>that negative test results be confirmed by viral<br>cell culture or an alternative method, such as a<br>FDA-cleared molecular assay. The test is<br>intended for professional and laboratory use. It is<br>to be used in conjunction with the BD Veritor™<br>System Reader. | The QuickVue RSV 10 test is an<br>immunoassay that allows for the rapid,<br>qualitative detection of respiratory<br>syncytial virus (RSV) antigen directly from<br>nasopharyngeal swab 'and nasopharyngeal<br>aspirate/wash specimens for symptomatic<br>pediatric patients (less than six years old). The<br>test is intended for use as an aid in the rapid<br>diagnosis of acute RSV infection. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by cell culture. The test is intended for professional and laboratory use. |
| Specimen<br>Types | Nasopharyngeal swab | Nasopharyngeal swab |
| Assay<br>Technology | Immunochromatographic | Immunochromatographic |
| Detection<br>Format | An opto-electronic reader determines the line<br>intensity at each of the spatially-defined test and<br>control line positions, interprets the results using<br>the scoring algorithm, and reports a positive,<br>negative, or invalid result on the LCD screen<br>based on pre-set thresholds. | Visual determination of presence or absence<br>of pink-to-red Test Line and the appearance of<br>a blue Procedural Control Line on the test strip<br>indicate the presence of RSV antigen. |
| Qualitative | Yes | Yes |
| Total Assay<br>Time | 10 minutes | 10 minutes |
| Control format | • Kit RSV positive and RSV negative dry swab<br>external controls<br>• Internal positive control<br>• Internal negative control | • Kit RSV positive control swab<br>• Kit RSV negative control swab<br>• Internal control lines |

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## SUMMARY OF PERFORMANCE DATA:

#### Analytical Sensitivity

The limit of detection (LOD) for the BD Veritor System for Rapid Detection of RSV test was established for the following RSV strains. The LOD for each strain represents the lowest concentration producing a positivity rate of ≥95% based on testing 60 or more replicates.

| Viral Strain | Calculated LOD<br>(TCID50/mL) | No. Positive / Total | % Positive |
|---------------------------------|-------------------------------|----------------------|------------|
| VR-26 (Long Subgroup A) | 1.43X105 | 57/60 | 95.0 |
| VR-955 (9320 subgroup B) | 3.98X104 | 57/60 | 95.0 |
| VR-1540 (A-2) | 1.94X103 | 59/60 | 98.3 |
| VR-1580 (Washington subgroup B) | 1.08X104 | 58/60 | 96.7 |
| VR-1400 (Wild Type subgroup B) | 2.96X103 | 76/80 | 95.0 |

TCID50/mL = 50% Tissue Culture Infectious Dose

#### Analytical Specificity (Cross Reactivity)

The BD Veritor System for Rapid Detection of RSV test was evaluated with bacteria and yeast at a target concentration of approximately 5 x 108 CFU/mL (CFU - Colony Forming Units). The viruses were evaluated at concentrations of 10°TCID50/mL or greater. Of the microorganisms tested, none showed cross-reactivity in the RSV test.

| Bacteriodes fragilis | Neisseria<br>sp. (Neisseria perflaus) |
|--------------------------------|---------------------------------------|
| Bordetella pertussis | Neisseria subflava |
| Candida albicans | Peptostreptococcus<br>anaerobius |
| Chlamydia<br>pneumoniae | Porphyromonas<br>asaccharolyticus |
| Corynebacterium<br>diphtherium | Prevotella oralis |
| Escherichia coli | Propionibacterium<br>acnes |
| Fusobacterium<br>nucleatum | Proteus mirabilis |
| Haemophilus<br>influenzae | Pseudomonas<br>aeruginosa |
| Haemophilus<br>parainfluenzae | Serratia marcescens |
| Kingella kingae | Staphylococcus<br>aureus |
| Klebsiella pneumoniae | Staphylococcus<br>epidermidis |
| Lactobacillus sp. | Streptococcus mutans |
| Legionella sp. | Streptococcus<br>pneumoniae |
| Moraxella catarrhalis | Streptococcus<br>pyogenes |
| Mycobacterium<br>tuberculosis | Streptococcus sp.<br>Group C |
| Mycoplasma<br>pneumoniae | Streptococcus sp.<br>Group G |

BD Diagnostic Systems Becton, Dickinson and Company

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BD Veritor TM System for Rapid Detection of RSV Clinical Laboratory Product

| Neisseria gonorrhoeae | Streptococcus<br>salivarius |
|------------------------|-----------------------------|
| Neisseria meningitidis | Veillonella parvula |
| Neisseria mucosa | |

| Adenovirus, Type 1 |
|---------------------------------------|
| Adenovirus, Type 7 |
| Cytomegalovirus |
| Enterovirus |
| HSV Type 1 |
| Human coronavirus OC43 |
| Human metapneumovirus<br>(hMPV-27 A2) |
| Human Parainfluenza |
| Influenza A/California/7/2009<br>H1N1 |
| Influenza A/Brisbane/10/2007<br>H3N2 |
| Influenza A/Victoria/3/75 H3N2 |
| Influenza B/Brisbane/60/2008 |
| Influenza B/Florida/4/2006 |
| Influenza B/Lee/40 |
| Measles virus |
| Mumps virus |
| Rhinovirus |

## Interfering Substances

Various substances were evaluated with the BD Veritor System for Rapid Detection of RSV test. These substances included whole blood (2%) and various medications. No interference was noted with this assay for any of the substances at the concentrations tested.

| Substance | Concentration |
|-----------------------------|---------------|
| Whole Blood | 2% |
| 4-Acetamidophenol | 10 mg/mL |
| Acetylsalicylic acid | 20 mg/mL |
| Chlorpheniramine<br>maleate | 5 mg/mL |
| Dextromethorphan | 10 mg/mL |
| Diphenhydramine<br>HCI | 5 mg/mL |
| Guaiacol Glyceryl<br>Ether | 20 mg/mL |
| Ibuprofen | 10 mg/mL |
| Loratidine | 100 ng/mL |
| Menthol Throat<br>Lozenges | 10 mg/mL |
| Ayr Saline Nasal Gel | 10 mg/mL |
| Oxymetazoline | 0.05 mg/mL |
| Phenylephrine | 1 mg/mL |
| Pseudoephedrine<br>HCI | 20 mg/mL |

| Substance | Concentration |
|----------------|---------------|
| Synagis | 4 []g/mL |
| Amantadine | 500 ng/mL |
| Hydrochloride | |
| Beclomethasone | 500 ng/mL |
| Budesonide | 500 ng/mL |
| Dexamethasone | 10 mg/mL |
| Fexofenadine | 500 ng/mL |
| FluMist | 1% |
| Flunisolide | 500 ng/mL |
| Fluticasone | 500 ng/mL |
| Mometasone | 500 ng/mL |
| Mupirocin | 500 ng/mL |
| Oseltamivir | 500 ng/mL |
| Purified Mucin | 1 mg/mL |
| Protein | |
| Ribavirin | 500 ng/mL |

BD Diagnostic Systems Becton, Dickinson and Company

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BD Veritor ™ System for Rapid Detection of RSV Clinical Laboratory Product

| Two OTC mouthwashes | 5 % |
|------------------------------|-------------|
| Four OTC nasal sprays | 10 % |
| Four OTC throat drops | 12.5 % |
| Homeopathic Allergy Medicine | 10 mg/mL |
| Albuterol | 0.083 mg/mL |
| Rimantadine | 500 ng/mL |
| Tobramycin | 500 ng/mL |
| Triamcinolone | 500 ng/mL |
| Zanamivir | 1 mg/mL |
| | |

#### CLINICAL STUDIES

Performance characteristics for the BD Veritor System for Rapid Detection of RSV test were established in a prospective multi-center clinical study conducted at eight POC U.S. testing sites during the 2012-2013 respiratory season. The performance of the BD Veritor RSV test was compared to a commercially available PCR method as well as viral culture. A total of 540 specimens were enrolled in the clinical trial. A total of 523 specimens had evaluable results for all three testing methods: PCR, viral cell culture and BD Veritor RSV. The study population was 42.6 % females and 57.4% males. The table below shows age distribution of the study population.

| | Demographics Summary - Age Group | |
|-----------|----------------------------------|------------|
| Age Group | Number | Percentage |
| <2 | 305 | 58.3 |
| 2 - 5 | 218 | 41.7 |
| Total | 523 | 100 |

The table below summarizes the performance obtained with clinical specimens using the BD Veritor™ System RSV test in comparison to a commercially available PCR. The overall positive percent agreement (PPA) and negative percent agreement (NPA) of the BD Veritor™ System RSV with a PCR comparator, based on these 523 specimens, are 81.6% (146/179) and 99.1% (341/344), respectively.

| BD Veritor™ RSV Compared to PCR | | | |
|---------------------------------------------------------------------------------------------------|-----|-----|-----|
| | PCR | | |
| BD Veritor RSV | P | N | |
| P | 146 | 3 | 149 |
| N | 33 | 341 | 374 |
| | 179 | 344 | 523 |
| Reference Method: PCR<br>PPA: 81.6% (95% C.I: 75.2%, 86.6%)<br>NPA: 99.1% (95% C.I: 97.5%, 99.7%) | | | |

BD Diagnostic Systems Becton, Dickinson and Company

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BD Veritor™ System for Rapid Detection of RSV Clinical Laboratory Product

BD Veritor™ System RSV test performance compared to viral cell culture was also evaluated in this study. For the same 523 specimens 91.8% (123/134) were positive.by both BD Veritor RSV and cultures, 93.3% (363/389) were negative by both BD Veritor RSV and culture. There were 26 BD Veritor RSV positive, viral cell culture negative specimens of which 23 were demonstrated to be RSV positive by an FDA cleared molecular assay.

Invalid rates for the BD Veritor™ System for Rapid Detection of RSV were calculated by dividing the number of invalids by the total number of evaluable specimens tested by the Veritor System. The overall invalid rate for the BD Veritor™ System for RSV based on the 523 specimens was determined to be 0.2% (1/523, 95% Cl: 0.03%, 1.07%).

#### Reproducibility

The reproducibility of the BD Veritor System for Rapid Detection of RSV test was evaluated at three clinical laboratory sites. The reproducibility panel was composed of 12 simulated RSV samples. These included moderate positive samples, low positive samples (near the assay limit of detection), and high negative samples (i.e., containing very low concentrations of virus) and negative samples. The panel was tested by two operators at each site for five consecutive days. The results are summarized below.

| BD Veritor™ RSV Reproducibility (% RSV Positive Results) | | | | |
|----------------------------------------------------------|---------------------------------|--------------------------------|---------------------------------|---------------------------------|
| Sample | P1 | P2 | S1 | Total |
| High<br>negative<br>RSV | 6.7% (2/30)<br>(1.8%, 21.3%) | 6.7% (2/30)<br>(1.8%, 21.3%) | 13.3% (4/30)<br>(5.3%, 29.7%) | 8.9% (8/90)<br>(4.6%, 16.6%) |
| Low positive<br>RSV | 90.0% (27/30)<br>(74.4%, 96.5%) | 76.7% (23/30)<br>(59.1%,88.2%) | 80.0% (24/30)<br>(62.7%, 90.5%) | 82.2% (74/90)<br>(73.1%, 88.8%) |
| Moderate<br>positive<br>RSV | 100% (30/30)<br>(88.6%, 100%) | 100% (30/30)<br>(88.6%, 100%) | 100% (30/30)<br>(88.6%, 100%) | 100% (90/90)<br>(95.9%, 100%) |
| Negative | 0% (0/30)<br>(0%, 11.3%) | 0% (0/30)<br>(0%, 11.3%) | 0% (0/30)<br>(0%, 11.3%) | 0% (0/90)<br>(0%, 4.1%) |

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Image /page/6/Picture/0 description: The image shows a black and white circular logo. The logo features the symbol of the Department of Health and Human Services (HHS) in the center. The symbol consists of a stylized eagle with three wavy lines extending from its tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

GREGORY P. PAYNE, RAC DIRECTOR, QUALITY SYSTEM AND REGULATORY AFFAIRS BECTON, DICKINSON AND COMPANY, BD DIAGNOSTICS 10865 ROAD TO THE CURE, SUITE 200 SAN DIEGO CA 92121

November 7,2013

Re: K132456

Trade/Device Name: BD Veritor™ System for Rapid Detection of RSV Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: I Product Code: GOG Dated: July 31, 2013 Received: August 14, 2013

Dear Mr. Payne:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Payne

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevjces/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

# Sally 标题/wat -S

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number: K132456

#### Device Name: BD Veritor™ System for Rapid Detection of RSV

#### Indications for Use:

The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from a direct nasopharyngeal swab from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 6 years. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method. such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor™ System Reader.

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

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Tamara V. Feldblyum -S 2013.10.30 14:46:05 -04'00'