(106 days)
Not Found
No
The device description mentions "specific algorithms" to determine the presence or absence of the target analyte, but there is no mention of AI, ML, or any learning/training process. The technology described is a reflectance-based measurement and algorithmic interpretation, which is not indicative of AI/ML.
No.
This device is an in vitro diagnostic (IVD) test used to detect RSV fusion protein to aid in the diagnosis of RSV infections, not to treat or prevent a disease.
Yes
The intended use explicitly states this test is "intended for in vitro diagnostic use to aid in the diagnosis of RSV infections."
No
The device description explicitly states it includes a "portable electronic device which uses a reflectance-based measurement method" and an "LCD on the instrument," indicating it is a hardware device with embedded software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section 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 20 years."
This statement clearly indicates that the device is designed to be used outside of the body (in vitro) to diagnose a medical condition (RSV infection).
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 nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media 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 20 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 TM System Reader.
Product codes
GQG
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 antigens bind 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 washes/aspirates, nasopharyngeal swabs
Indicated Patient Age Range
infants and pediatric patients under the age of 20 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)
Clinical Studies: Performance characteristics for the BD Veritor System for Rapid Detection of RSV test were established in multi-center clinical studies conducted at five U.S. trial sites during the 2011-2012 respiratory season. A total of 1174 prospectively collected specimens received in the laboratory with an order for respiratory virus testing were enrolled in the study. After exclusions, a total of 1146 specimens were evaluated using the BD Veritor System for Rapid Detection of RSV test and viral cell culture. The prospective specimens consisted of 440 Nasopharyngeal Wash /Aspirates (NPWA) and 706 nasopharyngeal swabs (NPS) in transport media from symptomatic patients.
The performance of the BD Veritor System for Rapid Detection of RSV test was compared to an FDA cleared D3 Duet™ DFA on R-Mix cell culture.
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, including moderate positive, low positive (near LOD), high negative (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.)
Clinical Performance- Veritor RSV to Viral Cell Culture, By Specimen Type:
NPS: Sensitivity: 88.4% (95% CI: 82.8%, 92.4%), Specificity: 98.3% (95% CI: 96.8%, 99.1%)
NPWA: Sensitivity: 91.6% (95% CI: 86.3%, 94.9%), Specificity: 94.5% (95% CI: 91.2%, 96.7%)
Reproducibility (% RSV positive results):
Sample S1 S3 S5 Total
High negative RSV: 0% (0/30) (0%,11.3%), 3.3% (1/30) (0.6%,16.7%), 3.3% (1/30) (0.6%,16.7%), 2.2% (2/90) (0.6%,7.7%)
Low positive RSV: 93.3% (28/30) (78.7%,98.2%), 76.7% (23/30) (59.1%,88.2%), 93.3% (28/30) (78.7%,98.2%), 87.8% (79/90) (79.4%,93%)
Moderate positive RSV: 100% (30/30) (88.6%,100%), 100% (30/30) (88.6%,100%), 100% (30/30) (88.6%,100%), 100% (90/90) (95.9%,100%)
Negative: 0% (0/30) (0%,11.3%), 0% (0/30) (0%,11.3%), 0% (0/30) (0%,11.3%), 0% (0/90) (0%,4.1%)
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™ System for Rapid Detection of RSV Clinical Laboratory Product
510(k) SUMMARY
SEP 1 8 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 12, 2012
DEVICE TRADE NAME: BD Veritor™ System for Rapid Detection of RSV
DEVICE COMMON NAME: Antigens Cf (including Cf Controls) Respiratory Syncytial Virus
DEVICE CLASSIFICATION: 21 CFR § 866.3480
PREDICATE DEVICES: 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 nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media 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 20 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 TM 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 antigens bind 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.
BD Diagnostic Systems Becton, Dickinson and Company
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 | ||
| nasopharyngeal washes/aspirates and | ||
| nasopharyngeal swabs in transport media 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 20 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 in transport media, | |
| nasopharyngeal wash/aspirate | Nasopharyngeal swab, nasopharyngeal | |
| 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 RSV antigen. | ||
| Qualitative | Yes | Yes |
| Total Assay | ||
| Time | Approximately 10 minutes | 10 minutes |
| Control format | • Kit RSV positive and RSV negative dry swab | |
| procedural control | ||
| • 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) | $1.43X10^5$ | 57/60 | 95.0 |
| VR-955 (9320 subgroup B) | $3.98X10^4$ | 57/60 | 95.0 |
| VR-1540 (A-2) | $1.94X10^3$ | 59/60 | 98.3 |
| VR-1580 (Washington subgroup B) | $1.08X10^4$ | 58/60 | 96.7 |
| VR-1400 (Wild Type subgroup B) | $2.96X10^3$ | 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 veast at a target concentration of approximately 10° CFU/mL (CFU – Colony Forming Units) with the exception of Fusobacterium nucleatum which was tested at 1.5 X 10°. The viruses were evaluated at concentrations of 103 TCIDsomiL or greater. Of the microorganisms tested, none showed cross-reactivity in the RSV test.
Bacteriodes fragilis Bordetella pertussis Candida albicans Chlamydia pneumoniae Corynebacterium diphtherium Escherichia coli Fusobacterium nucleatum
Haemophilus influenzae Haemophilus parainfluenzae Kingella kingae Klebsiella pneumoniae Lactobacillus sp. Legionella sp. Moraxella catarrhalis Mycobacterium tuberculosis Mycoplasma pneumoniae Neisseria gonorrhoeae Neisseria meningitidis Neisseria mucosa Neisseria sp.(Neisseria perflaus) Neisseria subflava Peptostreptococcus anaerobius Porphyromonas asaccharolyticus Prevotella oralis Propionibacterium acnes Proteus mirabilis Pseudomonas aeruginosa
BD Diagnostic Systems Becton, Dickinson and Company
Adenovirus, type 1 Adenovirus, type 7 Cytomegalovirus Enterovirus HSV Type 1 Human Coronavirus OC43 Human metapneumovirus (HMPV-27 A2) Human Parainfluenza Measles virus Mumps virus Rhinovirus
3
BD Veritor™ System for Rapid Detection of RSV Clinical Laboratory Product
Serratia marcescens Staphylococcus aureus Staphylococcus epidermidis Streptococcus mutans Streptococcus pneumoniae Streptococcus pyogenes Streptococcus sp. Group C Streptococcus sp. Group G Streptococcus salivarius Veillonella parvula
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
Tested |
|---------------------------------|-------------------------|
| 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 |
| Three OTC mouthwashes | 5 % |
| Four OTC nasal sprays | 10 % |
| Four OTC throat drops | 25 % |
| Homeopathic Allergy
Medicine | 10 mg/mL |
| Albuterol | 0.083 mg/mL |
| Synagis | 4 ug/mL |
| Amantadine Hydrochloride | 500 ng/mL |
| 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 Protein | 1 mg/mL |
BD Diagnostic Systems Becton, Dickinson and Company
4
BD Veritor TM System for Rapid Detection of RSV Clinical Laboratory Product
| Ribavirin | 500 ng/mL |
|---|---|
| Rimantadine | 500 ng/mL |
| Tobramycin | 500 ng/mL |
| Triamcinolone | 500 ng/mL |
| Zanamivir | 1 mg/mL |
Media Compatibility
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 RSV test. The effects of frozen storage of transport media samples on the stability of the antigen were also evaluated in this study by storing them for 24 hours at -20 ± 5°C. The media tested were: Amies. Bartel ViraTrans. BD Universal. Earle's Minimal Essential, Hank's Balanced Salts, M4, M4-RT, M5, M6, Normal Saline, and Phosphate Buffered Saline. No interference or compatibility issues were seen.
CLINICAL STUDIES
Performance characteristics for the BD Veritor System for Rapid Detection of RSV test were established in multi-center clinical studies conducted at five U.S. trial sites during the 2011-2012 respiratory season. A total of 1174 prospectively collected specimens received in the laboratory with an order for respiratory virus testing were enrolled in the study, of which. 26 were noncompliant with the study protocol and one was noncompliant on the viral cell culture reference testing level. Removal of these specimens yields a total of 1147 specimens. One additional specimen had a final undetermined viral cell culture reference result which could not be verified. Removal of this specimen results in a total of 1146 specimens. A total of 1146 were evaluated using the BD Veritor System for Rapid Detection of RSV test and viral cell culture. The prospective specimens consisted of 440 Nasopharyngeal Wash /Aspirates (NPWA) and 706 nasopharyngeal swabs (NPS) in transport media from symptomatic patients. 44.3% of the samples were from females and 55.7% from males. 80% of patients were 2 years and under.
The performance of the BD Veritor System for Rapid Detection of RSV test was compared to an FDA cleared D3 Duet™ DFA on R-Mix cell culture and is presented in the following tables
5
Summary of the performance of the BD Veritor System for Rapid Detection of RSV Test compared to viral cell culture by specimen type, all sites.
| Clinical Performance- Veritor RSV to Viral
| Cell Culture, By Specimen Type | ||||
|---|---|---|---|---|
| Culture | ||||
| Specimen | ||||
| Type | Veritor | |||
| RSV | P | N | ||
| NPS | P | 153 | 9* | 162 |
| NPS | N | 20 | 524 | 544 |
| 173 | 533 | 706 | ||
| Reference Method: Culture | ||||
| Sensitivity: 88.4% (95% CI: 82.8%, 92.4%) | ||||
| Specificity: 98.3% (95% CI: 96.8%, 99.1%) | ||||
| NPWA | P | 152 | 15** | 167 |
| NPWA | N | 14 | 259 | 273 |
| 166 | 274 | 440 |
Reference Method: Culture
Sensitivity: 91.6% (95% C1: 86.3%, 94.9%)
Specificity: 94.5% (95% C1: 91.2%, 96.7%)
*of the 9 BD Veritor RSV Positive, Viral Cell Culture negative specimens, 6 were positive by FDA cleared Prodesse Pro Flu+ molecular assay
** of the 15 BD Veritor RSV Positive, Viral Cell Culture negative specimens, 8 were positive by FDA cleared Prodesse Pro Flu+ molecular assay
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 | S1 | S3 | S5 | Total |
| High negative | ||||
| RSV | 0% (0/30) | |||
| (0%,11.3%) | 3.3% (1/30) | |||
| (0.6%,16.7%) | 3.3% (1/30) | |||
| (0.6%,16.7%) | 2.2% (2/90) | |||
| (0.6%,7.7%) | ||||
| Low positive | ||||
| RSV | 93.3% (28/30) | |||
| (78.7%,98.2%) | 76.7% (23/30) | |||
| (59.1%,88.2%) | 93.3% (28/30) | |||
| (78.7%,98.2%) | 87.8% (79/90) | |||
| (79.4%,93%) | ||||
| Moderate | ||||
| positive RSV | 100% (30/30) | |||
| (88.6%,100%) | 100% (30/30) | |||
| (88.6%,100%) | 100% (30/30) | |||
| (88.6%,100%) | 100% (90/90) | |||
| (95.9%,100%) | ||||
| Negative | 0% (0/30) | |||
| (0%,11.3%) | 0% (0/30) | |||
| (0%,11.3%) | 0% (0/30) | |||
| (0%,11.3%) | 0% (0/90) | |||
| (0%,4.1%) |
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with stylized wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
2012
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
Re: K121633
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: Class I · Product Code: GQG Dated: August 20, 2012 Received: August 22, 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 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, additions 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 r rease be actived a determination that your device complies with other requirements of the Act that I Dr Hao mass and regulations administered by other Federal agencies. You must of any I occur statules and securements, including, but not limited to: registration and listing (21
7
Page 2 - Gregory P. Payne, RAC
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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Vayain
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
8
BD Veritor " System for Rapid Detection of RSV Clinical Laboratory Product
510(k) Number:
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 nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media 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 20 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 FDAcleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor TM System Reader.
Prescription Use ー V -(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 CDRH, Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD)
Tamara Feldbly
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121633