(93 days)
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 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.
Here's a summary of the acceptance criteria and study details for the BD Veritor™ System for Rapid Detection of RSV, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Metric | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (LoD) | Lowest concentration producing ≥95% positivity. | VR-26 (Long Subgroup A): 1.43X10⁵ TCID₅₀/mL (95.0%) |
| VR-955 (9320 subgroup B): 3.98X10⁴ TCID₅₀/mL (95.0%) | ||
| VR-1540 (A-2): 1.94X10³ TCID₅₀/mL (98.3%) | ||
| VR-1580 (Washington subgroup B): 1.08X10⁴ TCID₅₀/mL (96.7%) | ||
| VR-1400 (Wild Type subgroup B): 2.96X10³ TCID₅₀/mL (95.0%) | ||
| Analytical Specificity (Cross-Reactivity) | No cross-reactivity with common bacteria/yeast (5x10⁸ CFU/mL) and viruses (10⁶ TCID₅₀/mL). | None of the tested microorganisms showed cross-reactivity. |
| Interfering Substances | No interference from specified substances at given concentrations. | No interference noted for any of the tested substances. |
| Clinical Performance (vs. PCR) | Positive Percent Agreement (PPA) with PCR. | 81.6% (95% C.I: 75.2%, 86.6%) |
| Negative Percent Agreement (NPA) with PCR. | 99.1% (95% C.I: 97.5%, 99.7%) | |
| Clinical Performance (Invalid Rate) | Overall invalid rate. | 0.2% (1/523, 95% C.I: 0.03%, 1.07%) |
| Reproducibility | Consistent results across sites, operators, and days for various sample types. | High negative RSV: 8.9% positive (8/90 total) |
| Low positive RSV: 82.2% positive (74/90 total) | ||
| Moderate positive RSV: 100% positive (90/90 total) | ||
| Negative: 0% positive (0/90 total) |
Study Information:
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Analytical Sensitivity (LoD): 60 or more replicates per viral strain. For VR-1400, 80 replicates were used.
- Analytical Specificity: Bacteria/yeast tested at approx. 5 x 10⁸ CFU/mL; viruses at 10⁶ TCID₅₀/mL or greater. Specific numbers of tests for each microorganism are not given, but a list of ~40 bacteria/fungi and ~20 viruses were tested.
- Interfering Substances: Specific concentrations for each substance listed. Number of tests per substance not explicitly stated.
- Clinical Studies: 523 evaluable specimens (out of 540 collected).
- Age distribution: 305 (<2 years old, 58.3%), 218 (2-5 years old, 41.7%).
- Gender: 42.6% females, 57.4% males.
- Reproducibility: 90 samples per condition (12 simulated RSV samples, tested by 2 operators at 3 sites for 5 consecutive days).
- Data Provenance:
- Analytical Studies: Performed by the manufacturer (BD).
- Clinical Studies: Prospective multi-center clinical study conducted at eight Point-of-Care (POC) U.S. testing sites during the 2012-2013 respiratory season.
- Test Set Sample Size:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts for establishing ground truth. Instead, it relies on objective laboratory methods:
- Analytical Sensitivity (LoD): Ground truth established based on viral culture concentrations (TCID₅₀/mL).
- Analytical Specificity: Ground truth established based on known presence/absence and concentration of specific microorganisms.
- Interfering Substances: Ground truth established based on known presence/absence and concentration of specific substances.
- Clinical Studies: Ground truth for the clinical test set was established by a commercially available PCR method and viral cell culture. For discordant results between BD Veritor RSV and viral cell culture, an FDA-cleared molecular assay was used to resolve discrepancies (e.g., 23 out of 26 BD Veritor positive, culture negative specimens were confirmed RSV positive by an FDA-cleared molecular assay).
- The document does not specify the number or qualifications of experts for establishing ground truth. Instead, it relies on objective laboratory methods:
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Clinical Studies: While not explicitly a "2+1" or "3+1" expert adjudication, there was a form of adjudication for discordant results between the BD Veritor RSV and viral cell culture using an FDA-cleared molecular assay as a confirmatory method. The primary comparison was against PCR and viral cell culture as reference methods.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is an immunoassay with an instrumented read, not an AI system interpreted by human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device. The results are interpreted by the "BD Veritor™ System Reader" using "specific algorithms."
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, performance data for the device, which includes an instrumented read using "specific algorithms," is presented as standalone algorithm performance (without direct human interpretation of the test strip, as the reader interprets the results). The clinical study data (PPA, NPA) represents the performance of the BD Veritor™ System as a whole.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Analytical Studies: Laboratory-defined concentrations and known presence/absence of microorganisms and substances.
- Clinical Studies:
- Commercially available PCR method.
- Viral cell culture.
- FDA-cleared molecular assay (used for confirmation of discordant results between BD Veritor RSV and viral cell culture).
-
The sample size for the training set:
- The document does not provide information on a training set sample size. This is typical for immunoassay devices where the "algorithm" is embedded in the reader based on pre-set thresholds derived from analytical validation and clinical studies, rather than a machine learning model that requires a distinct training phase with a dedicated dataset.
-
How the ground truth for the training set was established:
- As no specific training set is mentioned for an AI/machine learning model, this information is not applicable. The "specific algorithms" within the BD Veritor™ System Reader are likely based on fixed thresholds determined during product development and analytical validation, rather than from a conventional machine learning training process with ground-truth labels.
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BD Veritor "M System for Rapid Detection of RSV Clinical Laboratory Product
510(k) SUMMARY
| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY10865 Road to the Cure, Suite 200San Diego, CA 92121Phone: 858-795-7890Fax: 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 SyncytialVirus |
| 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) |
| ProductFeature | BD Veritor™ System for RSV | Quidel QuickView RSV 10 test (K101918) |
|---|---|---|
| Intended Use | The BD Veritor™ System for Rapid Detection ofRespiratory Syncytial Virus (RSV) is achromatographic immunoassay with aninstrumented read for the direct and qualitativedetection of RSV fusion protein from a directnasopharyngeal swab from patients suspected ofhaving a viral respiratory infection. This test isintended for in vitro diagnostic use to aid in thediagnosis of RSV infections in infants andpediatric patients under the age of 6 years.Negative results do not preclude RSV infectionand should not be used as the sole basis fortreatment or for other management decisions. Anegative test is presumptive. It is recommendedthat negative test results be confirmed by viralcell culture or an alternative method, such as aFDA-cleared molecular assay. The test isintended for professional and laboratory use. It isto be used in conjunction with the BD Veritor™System Reader. | The QuickVue RSV 10 test is animmunoassay that allows for the rapid,qualitative detection of respiratorysyncytial virus (RSV) antigen directly fromnasopharyngeal swab 'and nasopharyngealaspirate/wash specimens for symptomaticpediatric patients (less than six years old). Thetest is intended for use as an aid in the rapiddiagnosis 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. |
| SpecimenTypes | Nasopharyngeal swab | Nasopharyngeal swab |
| AssayTechnology | Immunochromatographic | Immunochromatographic |
| DetectionFormat | An opto-electronic reader determines the lineintensity at each of the spatially-defined test andcontrol line positions, interprets the results usingthe scoring algorithm, and reports a positive,negative, or invalid result on the LCD screenbased on pre-set thresholds. | Visual determination of presence or absenceof pink-to-red Test Line and the appearance ofa blue Procedural Control Line on the test stripindicate the presence of RSV antigen. |
| Qualitative | Yes | Yes |
| Total AssayTime | 10 minutes | 10 minutes |
| Control format | • Kit RSV positive and RSV negative dry swabexternal controls• Internal positive control• Internal negative control | • Kit RSV positive control swab• Kit RSV negative control swab• 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(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 | Neisseriasp. (Neisseria perflaus) |
|---|---|
| Bordetella pertussis | Neisseria subflava |
| Candida albicans | Peptostreptococcusanaerobius |
| Chlamydiapneumoniae | Porphyromonasasaccharolyticus |
| Corynebacteriumdiphtherium | Prevotella oralis |
| Escherichia coli | Propionibacteriumacnes |
| Fusobacteriumnucleatum | Proteus mirabilis |
| Haemophilusinfluenzae | Pseudomonasaeruginosa |
| Haemophilusparainfluenzae | Serratia marcescens |
| Kingella kingae | Staphylococcusaureus |
| Klebsiella pneumoniae | Staphylococcusepidermidis |
| Lactobacillus sp. | Streptococcus mutans |
| Legionella sp. | Streptococcuspneumoniae |
| Moraxella catarrhalis | Streptococcuspyogenes |
| Mycobacteriumtuberculosis | Streptococcus sp.Group C |
| Mycoplasmapneumoniae | Streptococcus sp.Group G |
BD Diagnostic Systems Becton, Dickinson and Company
Page 7
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BD Veritor TM System for Rapid Detection of RSV Clinical Laboratory Product
| Neisseria gonorrhoeae | Streptococcussalivarius |
|---|---|
| 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/7/2009H1N1 |
| Influenza A/Brisbane/10/2007H3N2 |
| 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 |
| Chlorpheniraminemaleate | 5 mg/mL |
| Dextromethorphan | 10 mg/mL |
| DiphenhydramineHCI | 5 mg/mL |
| Guaiacol GlycerylEther | 20 mg/mL |
| Ibuprofen | 10 mg/mL |
| Loratidine | 100 ng/mL |
| Menthol ThroatLozenges | 10 mg/mL |
| Ayr Saline Nasal Gel | 10 mg/mL |
| Oxymetazoline | 0.05 mg/mL |
| Phenylephrine | 1 mg/mL |
| PseudoephedrineHCI | 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: PCRPPA: 81.6% (95% C.I: 75.2%, 86.6%)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 |
| HighnegativeRSV | 6.7% (2/30)(1.8%, 21.3%) | 6.7% (2/30)(1.8%, 21.3%) | 13.3% (4/30)(5.3%, 29.7%) | 8.9% (8/90)(4.6%, 16.6%) |
| Low positiveRSV | 90.0% (27/30)(74.4%, 96.5%) | 76.7% (23/30)(59.1%,88.2%) | 80.0% (24/30)(62.7%, 90.5%) | 82.2% (74/90)(73.1%, 88.8%) |
| ModeratepositiveRSV | 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%) |
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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'
§ 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.