(149 days)
Not Found
No
The device description and performance studies describe a lateral flow immunoassay that relies on visual interpretation of color lines, not AI/ML for analysis.
No.
It is an in vitro diagnostic test intended to aid in the diagnosis of acute respiratory syncytial viral infections, not to treat them.
Yes
The intended use explicitly states, "The test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral infections."
No
The device description clearly outlines physical components like test strips, extraction tubes, and reagents, indicating it is a hardware-based diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, nasopharyngeal aspirate and/or nasal wash specimens". This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a patient's health status (presence of RSV infection).
- Device Description: The description details how the test works by reacting the patient specimen with reagents on a test strip to detect viral antigens. This is a typical process for an in vitro diagnostic test.
- Specimen Type: The test uses nasopharyngeal swab, nasopharyngeal aspirate, and/or nasal wash specimens, which are biological samples taken from the body.
- Purpose: The test is intended as an "aid in the rapid diagnosis of acute respiratory syncytial viral infections," which is a diagnostic purpose.
- Performance Studies: The summary of performance studies describes clinical studies comparing the test to viral culture and a predicate device, which are standard practices for evaluating the performance of IVDs.
All these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QuickVue® RSV test allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, nasopharyngeal aspirate and/or nasal wash specimens for symptomatic patients eighteen years of age and younger. The test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral infections. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.
Product codes
MCE
Device Description
The QuickVue® RSV test is a lateral-flow immunoassay using highly sensitive monoclonal antibodies that are specific for RSV antigens. The test is specific to RSV antigen with no known cross-reactivity to normal flora or other known respiratory pathogens. Nasopharyngeal swabs, nasopharyngeal aspirate and/or nasal washes serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 15 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains RSV antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If RSV viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasopharyngeal
Indicated Patient Age Range
Eighteen years of age and younger
Intended User / Care Setting
Professional and laboratory use. Physician's Office.
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)
Numerous studies were undertaken to document the performance characteristics of the test to the predicate device. These studies included the following:
- A multi-center field clinical study was conducted. Sensitivity, specificity and overall accuracy were calculated using nasopharyngeal aspirates and nasopharyngeal swabs compared to viral culture.
- A clinical performance study with frozen nasal washes demonstrated the QuickVue® RSV gave excellent agreement with a predicate device presently marketed legally in the United States.
- Physician's Office studies were conducted to demonstrate that physician office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly.
- Analytical studies demonstrated lot-to-lot consistency, inter- and intra-lot precision, that common drugs and biologicals did not interfere with the test's performance, and that variations in the test method did not impact the test's performance.
- A transport media study to select suitable media for the transport of clinical samples identified several transport media that performed optimally.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, specificity and overall accuracy were calculated.
Predicate Device(s)
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.
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Koloa08
510(k) SUMMARY
Submitted By:
Quidel Corporation 10165 McKellar Court San Diego, California 92121 408-690-4938 Cell: Telephone: 415-664-4904 858-646-8045 Fax:
John D. Tamerius, Ph.D.
QuickVue® RSV test
SEP - 8 2006
Submission Contact:
Date Prepared:
Device Trade Name:
Respiratory syncytial Virus (RSV) Test Common Name:
Binax NOW® RSV Test (K032166) Predicate Device:
21 CFR 866.3480 / Respiratory syncytial virus Device Classification/Name: serological reagents.
April 11, 2006
The device, the QuickVue® RSV test, is similar to other FDA-cleared devices used for the qualitative detection of RSV directly from clinical specimens. These tests are used to aid in the diagnosis of disease caused by respiratory syncytial viruses and provides epidemiological these diseases (21CFR on information 866.3480). The Food and Drug Administration has classified serological test systems for the detection of respiratory syncytial virus as Class 1.
Intended Use:
The QuickVue® RSV test allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, nasopharyngeal aspirate and/or nasal wash specimens for symptomatic patients eighteen years of age and younger. The test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral infections. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.
1
Physiologic Basis of the Test:
Respiratory syncytial virus (RSV) is a single stranded (negative strand) RNA virus of the Paramyxoviridae family. It is the causative agent of a highly contagious, acute, viral infection of the respiratory tract. RSV infection is recognized as the leading cause of hospitalization of children during the first year of life. It is also the major viral cause of nosocomial illness in children already hospitalized for other reasons. Half of all infants become infected during their first year of life. Virtually all have been infected by their second year. Infection involving the lower respiratory tract carries an associated mortality rate of 0.5%, especially in premature infants or infants and children with underlying lung disease. There is a need for rapid diagnosis of RSV. This can lead to more effective care and management of these patients.
RSV causes approximately 100,000 hospitalizations and as many as 4,500 deaths in the U.S. each year. Recently, it has become more apparent that RSV is an important pathogen for the elderly and in the immunocompromised patient.
The QuickVue® RSV test is a lateral-flow immunoassay using highly sensitive monoclonal antibodies that are specific for RSV antigens. The test is specific to RSV antigen with no known cross-reactivity to normal flora or other known respiratory pathogens.
Device Description: Nasopharyngeal swabs, nasopharyngeal aspirate and/or nasal washes serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral After extraction, the Test Strip is antigens. placed in the Extraction Tube for 15 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip.
the extracted specimen contains RSV lf antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If RSV viral antigens are not present,
2
Device Description (cont.)
or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.
Device Comparison: -
.
... ... ...
| Features | QuickVue®
RSV Test | Binax NOW® RSV Test |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QuickVue® RSV test allows
for the rapid, qualitative detection
of respiratory syncytial virus (RSV)
directly from nasopharyngeal
swab, nasopharyngeal aspirate
and/or nasal wash specimens.
The test is intended for use as an
aid in the rapid diagnosis of acute
respiratory syncytial viral
infections. Negative test results
should be confirmed by cell
culture. The test is intended for
professional and laboratory use. | The Binax NOW® RSV Test is a
rapid immunochromatographic
assay for the qualitative detection
of respiratory syncytial virus (RSV)
fusion protein antigen in nasal
wash and nasopharyngeal swab
specimens from symptomatic
patients. This test is intended for
in vitro diagnostic use to aide in
the diagnosis of RSV infections in
neonatal and pediatric patients
under the age of five. It is
recommended that negative test
results be confirmed by culture. |
| Specimen Types | Nasopharyngeal Swab
Nasopharyngeal Aspirate and/or
Nasal Wash | Nasopharyngeal Swab
Nasal Wash |
| Extract / Elute | Extraction reagent used for
swab/aspirate/wash | Transport liquid used for swab
Wash – no dilution required |
| Read Result Time | 15 Minutes | 15 Minutes |
| Format | Lateral-flow immunoassay
Dipstick | Lateral-flow
immunochromatographic
membrane assay
Cardboard with book shaped
hinge |
| Control Features | Procedural Control Line
Clearing of Background | Procedural Control Line
Clearing of Background |
| External Controls | Positive RSV swab
RSV Negative swab coated with
Streptococcuе C antigen | Positive RSV swab
RSV Negative swab coated with
Streptococcus A antigen |
3
Summary of Performance Data:
Numerous studies were undertaken to document the performance characteristics Nomerous stadios word andorants of the test to the predicate device. These studies included the following:
- A multi-center field clinical study was conducted. Sensitivity, specificity 1. and overall accuracy were calculated using nasopharyngeal aspirates and nasopharyngeal swabs compared to viral culture.
- A clinical performance study with frozen nasal washes demonstrated the 2. QuickVue® RSV gave excellent agreement with a predicate device presently marketed legally in the United States.
- Physician's Office studies were conducted to demonstrate that physician 3. office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly.
- Analytical studies demonstrated lot-to-lot consistency, inter- and intra-4. lot precision, that common drugs and biologicals did not interfere with the test's performance, and that variations in the test method did not impact the test's performance.
- A transport media study to select suitable media for the transport of 5. clinical samples identified several transport media that performed optimally.
Conclusion:
These studies demonstrated the substantial equivalence of the QuickVue® RSV test to existing products already marketed. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP = 8 2006
John D. Tamerius, Ph.D. Vice President, Clinical and Regulatory Affairs Quidel Corporation 10165 McKellar Court San Diego, CA 92121
Re: K061008 Trade/Device Name: QuickVue® RSV Test Regulation Number: 21 CFR § 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: I Product Code: MCE Dated: August 17, 2006 Received: August 21, 2006
Dear Dr. Tamerius:
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, atton
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
4061008
Device Name:
QuickVue® RSV test
Indications for Use:
The QuickVue® RSV test allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, nasopharyngeal aspirate and/or nasal wash specimens for symptomatic patients eighteen years of age and younger. The test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral infections. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.
Prescription Use_ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Solgath
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of of 1
510(k)________________________________________________________________________________________________________________________________________________________________________
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