(93 days)
Not Found
No
The device description mentions "specific algorithms" for interpreting results, but there is no mention of AI, ML, or any learning process involved in these algorithms. The performance studies describe traditional analytical and clinical validation methods, not training or testing of an AI/ML model.
No
The device is described as an in vitro diagnostic tool for detecting RSV, not for treating or preventing disease.
Yes
The product's intended use explicitly states: "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." The device description also highlights its function to "qualitatively detect RSV fusion protein in samples... to determine the presence or absence of any target analyte(s)." These statements clearly indicate its role in diagnosing diseases.
No
The device description explicitly states it is a "chromatographic immunoassay with an instrumented read" and is interpreted by the "BD Veritor™ System Reader, a portable electronic device". This indicates the device includes physical hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states "This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections...".
- Device Description: It describes a test that analyzes a biological sample (nasopharyngeal swab) in vitro (outside the body) to detect a specific analyte (RSV fusion protein) for diagnostic purposes.
- Professional and Laboratory Use: The intended user and setting are consistent with IVD use.
The entire description aligns with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GOG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal swab
Indicated Patient Age Range
infants and pediatric patients under the age of 6 years
Intended User / Care Setting
professional and laboratory use
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 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: VR-26 (Long Subgroup A); Calculated LOD (TCID50/mL): 1.43X10^5; No. Positive / Total: 57/60; % Positive: 95.0
Viral Strain: VR-955 (9320 subgroup B); Calculated LOD (TCID50/mL): 3.98X10^4; No. Positive / Total: 57/60; % Positive: 95.0
Viral Strain: VR-1540 (A-2); Calculated LOD (TCID50/mL): 1.94X10^3; No. Positive / Total: 59/60; % Positive: 98.3
Viral Strain: VR-1580 (Washington subgroup B); Calculated LOD (TCID50/mL): 1.08X10^4; No. Positive / Total: 58/60; % Positive: 96.7
Viral Strain: VR-1400 (Wild Type subgroup B); Calculated LOD (TCID50/mL): 2.96X10^3; No. Positive / Total: 76/80; % Positive: 95.0
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 10^8 CFU/mL. The viruses were evaluated at concentrations of 10^0 TCID50/mL or greater. Of the microorganisms tested, none showed cross-reactivity in the RSV test.
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Invalid rate: 0.2% (1/523, 95% Cl: 0.03%, 1.07%).
Predicate Device(s)
Quidel QuickVue RSV 10 test (K101918)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3480 Respiratory syncytial virus serological reagents.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
BD Veritor "M System for Rapid Detection of RSV Clinical Laboratory Product
510(k) SUMMARY
| 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 NOV 0 7 2013 |
| 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
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.
1
DEVICE COMPARISON:
| The BD Veritor™ System for Rapid Detection of RSV was compared to the Quidel | |
|---|---|
| QuickVue RSV 10 test (K101918) |
| Product
| Feature | BD Veritor™ System for RSV | Quidel QuickView RSV 10 test (K101918) |
|---|---|---|
| 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. | The QuickVue RSV 10 test is an | |
| immunoassay that allows for the rapid, | ||
| qualitative detection of respiratory | ||
| syncytial virus (RSV) antigen directly from | ||
| nasopharyngeal swab 'and nasopharyngeal | ||
| aspirate/wash specimens for symptomatic | ||
| pediatric patients (less than six years old). The | ||
| test is intended for use as an aid in the rapid | ||
| 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 | ||
| Types | Nasopharyngeal swab | Nasopharyngeal swab |
| 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 RSV antigen. | ||
| Qualitative | Yes | Yes |
| Total Assay | ||
| Time | 10 minutes | 10 minutes |
| Control format | • Kit RSV positive and RSV negative dry swab | |
| external controls | ||
| • Internal positive control | ||
| • Internal negative control | • Kit RSV positive control swab | |
| • Kit RSV negative control swab | ||
| • Internal control lines |
・
.
:
.
2
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
(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
sp. (Neisseria perflaus) |
|--------------------------------|---------------------------------------|
| Bordetella pertussis | Neisseria subflava |
| Candida albicans | Peptostreptococcus
anaerobius |
| Chlamydia
pneumoniae | Porphyromonas
asaccharolyticus |
| Corynebacterium
diphtherium | Prevotella oralis |
| Escherichia coli | Propionibacterium
acnes |
| Fusobacterium
nucleatum | Proteus mirabilis |
| Haemophilus
influenzae | Pseudomonas
aeruginosa |
| Haemophilus
parainfluenzae | Serratia marcescens |
| Kingella kingae | Staphylococcus
aureus |
| Klebsiella pneumoniae | Staphylococcus
epidermidis |
| Lactobacillus sp. | Streptococcus mutans |
| Legionella sp. | Streptococcus
pneumoniae |
| Moraxella catarrhalis | Streptococcus
pyogenes |
| Mycobacterium
tuberculosis | Streptococcus sp.
Group C |
| Mycoplasma
pneumoniae | Streptococcus sp.
Group G |
BD Diagnostic Systems Becton, Dickinson and Company
Page 7
3
BD Veritor TM System for Rapid Detection of RSV Clinical Laboratory Product
| Neisseria gonorrhoeae | Streptococcus
salivarius |
|------------------------|-----------------------------|
| Neisseria meningitidis | Veillonella parvula |
| Neisseria mucosa | |
| Adenovirus, Type 1 |
|---|
| Adenovirus, Type 7 |
| Cytomegalovirus |
| Enterovirus |
| HSV Type 1 |
| Human coronavirus OC43 |
| Human metapneumovirus |
| (hMPV-27 A2) |
| Human Parainfluenza |
| Influenza A/California/7/2009 |
| H1N1 |
| Influenza A/Brisbane/10/2007 |
| 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 | |
| maleate | 5 mg/mL |
| Dextromethorphan | 10 mg/mL |
| Diphenhydramine | |
| HCI | 5 mg/mL |
| Guaiacol Glyceryl | |
| Ether | 20 mg/mL |
| Ibuprofen | 10 mg/mL |
| Loratidine | 100 ng/mL |
| Menthol Throat | |
| Lozenges | 10 mg/mL |
| Ayr Saline Nasal Gel | 10 mg/mL |
| Oxymetazoline | 0.05 mg/mL |
| Phenylephrine | 1 mg/mL |
| Pseudoephedrine | |
| 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
4
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 |