(175 days)
No
The description mentions "method-specific algorithms" for processing results, which is standard for many medical devices and does not indicate the use of AI or ML. There is no mention of AI, ML, deep learning, neural networks, or any related concepts in the document.
No
This device is a qualitative test used for the rapid diagnosis of acute RSV infections by detecting RSV nucleoprotein antigen. It aids in diagnosis but does not provide therapy or treatment.
Yes
The device is described as a "qualitative test intended for use as an aid in the rapid diagnosis of acute RSV infections." This clearly indicates its purpose is to help in the diagnosis of a medical condition.
No
The device description clearly outlines a system that includes a physical "Sofia Analyzer" and "Cassette" components, in addition to the software that processes the results. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states the device is intended for the "detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients." This involves testing a specimen taken from the human body in vitro (outside the body) to provide information about a disease state (acute RSV infections).
- Device Description: The process involves disrupting viral particles in a patient specimen and then using immunofluorescence technology to detect specific antigens within that specimen. This is a classic example of an in vitro diagnostic test.
- Specimen Type: The test uses nasopharyngeal swab and nasopharyngeal aspirate/wash specimens, which are biological samples taken from a patient.
- Purpose: The test is intended as an "aid in the rapid diagnosis of acute RSV infections." This directly relates to providing diagnostic information.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients less than 19 years of age. 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 result is presumptive, and it is recommended these results be confirmed by virus culture or an FDA-cleared RSV molecular assay.
Product codes
GQG
Device Description
The Sofia RSV FIA test employs immunofluorescence technology that is used with the Sofia Analyzer for the rapid detection of RSV antigens. The Sofia RSV FIA test involves the disruption of RSV viral antigens. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the Cassette sample well. From the sample well. the specimen migrates through a test strip containing various unique chemical environments. If RSV viral antigens are present, they will be trapped in a specific location.
Note: Depending upon the user's choice, the cassette is either placed inside of the Sofia Analyzer for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into the Sofia Analyzer to be scanned (Read Now Mode).
The Sofia Analyzer will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. The Sofia Analyzer will display the test results (Positive, Negative, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal
Indicated Patient Age Range
pediatric patients less than 19 years of age.
Intended User / Care Setting
Not Found
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)
-
- A multi-center field clinical study was undertaken to document the performance characteristics of the test. Sensitivity and specificity were calculated using nasopharyngeal swab and nasopharyngeal aspirate/wash specimens, both fresh and after storage in transport media.
-
- A reproducibility study was performed to demonstrate intra- and inter-operator reproducibility and intra- and inter-laboratory reproducibility with a panel of test samples at various RSV concentrations.
-
- Analytical studies included Limit of Detection, analytical reactivity, cross reactivity, interfering substances, operating temperature, lab precision/repeatability, viral transport media, inter-analyzer variation assessment, calibration cycle, and various flex studies.
These studies demonstrated the substantial equivalence of the Sofia RSV FIA for use with the Sofia Analyzer to the existing product already marketed, BD Veritor System for Rapid Detection of RSV, K121633. They further demonstrated the suitability of the product for laboratory and professional use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity and specificity were calculated using nasopharyngeal swab and nasopharyngeal aspirate/wash specimens, both fresh and after storage in transport media.
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.
0
510(k) SUMMARY
| Submitted By: | Quidel Corporation
10165 McKellar Court
San Diego, California 92121
Telephone: 858-552-7908
Fax: 858-646-8045 | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submission Contact: | John D. Tamerius, Ph.D. | AUG 1 3 2013 |
| Date Prepared: | February 15, 2013 | |
| Device Trade Name: | Sofia® RSV FIA | |
| Common Name: | Respiratory Syncytial Virus (RSV) Test | |
| Predicate Device: | BD Veritor™ System for Rapid Detection of RSV,
K121633 | |
| Device Classification/Name: | 21 CFR 866.3480 / Respiratory syncytial virus
serological reagents | |
| | These tests are used to aid in the diagnosis of disease
caused by respiratory syncytial viruses and provide
epidemiological information on these diseases (21
CFR 866.3480). The Food and Drug Administration
has classified serological test systems for the
detection of respiratory syncytial virus as Class I. | |
| Intended Use: | The Sofia RSV FIA employs immunofluorescence
for detection of respiratory syncytial virus (RSV)
nucleoprotein antigen in nasopharyngeal swab and
nasopharyngeal aspirate/wash specimens taken
directly from symptomatic patients. This qualitative
test is intended for use as an aid in the rapid diagnosis
of acute RSV infections in pediatric patients less than
19 years of age. 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 result is presumptive, and it is
recommended these results be confirmed by virus
culture or an FDA-cleared RSV molecular assay. | |
1
Physiologic Basis of the Test: RSV is a causative agent of highly contagious, acute. viral infection of the respiratory tract in pediatric and elderly populations. Respiratory syncytial virus is a single-stranded RNA virus. Nearly half of all children become infected by RSV in their first year of life. It is also the major viral cause of nosocomial illness in children already hospitalized for other reasons. In the United States. RSV is estimated to be responsible for 73,400 to 126,300 hospitalizations annually for bronchiolitis and pneumonia alone among children younger than 1 year. In children hospitalized with RSV infection. it is believed to be the most common viral cause of death in children younger than 5 years, particularly in children younger than one year. Among children hospitalized with RSV infection, the mortality rate is estimated to be as low as 0.3% to 1.0% and in the range of 2.5% to 4.0% for children with underlying cardiac or pulmonary disease.
2
Device Description:
The Sofia RSV FIA test employs immunofluorescence technology that is used with the Sofia Analyzer for the rapid detection of RSV antigens. The Sofia RSV FIA test involves the disruption of RSV viral antigens. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the Cassette sample well. From the sample well. the specimen migrates through a test strip containing various unique chemical environments. If RSV viral antigens are present, they will be trapped in a specific location.
Note: Depending upon the user's choice, the cassette is either placed inside of the Sofia Analyzer for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into the Sofia Analyzer to be scanned (Read Now Mode).
The Sofia Analyzer will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. The Sofia Analyzer will display the test results (Positive, Negative, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.
3
Device Comparison:
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Features | Sofia RSV FIA | BD Veritor™ System for Rapid |
| Detection of RSV, K121633 | ||
| Intended Use | The Sofia RSV FIA employs | |
| immunofluorescence for detection | ||
| of respiratory syncytial virus | ||
| (RSV) nucleoprotein antigen in | ||
| nasopharyngeal swab and | ||
| nasopharyngeal aspirate/wash | ||
| specimens taken directly from | ||
| symptomatic patients. This | ||
| qualitative test is intended for use | ||
| as an aid in the rapid diagnosis of | ||
| acute RSV infections in pediatric | ||
| patients less than 19 years of age. | ||
| 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 result is presumptive, | ||
| and it is recommended these results | ||
| be confirmed by virus culture or an | ||
| FDA-cleared RSV molecular assay. | 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 samples 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. | ||
| Read Results | Read results on instrument screen | |
| or print with optional printer | Read results on instrument screen | |
| Instrument | Sofia Analyzer | BD Veritor |
| Calibrator | Yes; a Calibration Cassette and QC | |
| Card are provided | No calibrator; a verification device is | |
| provided to monitor device function | ||
| Specimen | ||
| Types | Nasopharyngeal swab and | |
| nasopharyngeal aspirate/wash | ||
| specimens; all specimens can be | ||
| tested fresh or after transport in | ||
| media | Nasopharyngeal swab in transport | |
| media and nasopharyngeal | ||
| aspirate/wash specimens | ||
| Read Result | ||
| Time | 15 Minutes | Approximately 10 Minutes |
| Item | Proposed Device | Predicate Device |
| Features | Sofia RSV FIA | BD Veritor™ System for Rapid |
| Detection of RSV, K121633 | ||
| External | ||
| Controls | RSV positive swab | |
| RSV negative swab | RSV positive swab | |
| RSV negative swab |
4
Summary of Performance Data:
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to the predicate device. These studies included the following:
-
- A multi-center field clinical study was undertaken to document the performance characteristics of the test. Sensitivity and specificity were calculated using nasopharyngeal swab and nasopharyngeal aspirate/wash specimens, both fresh and after storage in transport media.
-
- A reproducibility study was performed to demonstrate intra- and inter-operator reproducibility and intra- and inter-laboratory reproducibility with a panel of test samples at various RSV concentrations.
-
- Analytical studies included Limit of Detection, analytical reactivity, cross reactivity, interfering substances, operating temperature, lab precision/repeatability, viral transport media, inter-analyzer variation assessment, calibration cycle, and various flex studies.
Conclusion:
These studies demonstrated the substantial equivalence of the Sofia RSV FIA for use with the Sofia Analyzer to the existing product already marketed, BD Veritor System for Rapid Detection of RSV, K121633. 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.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle-like emblem. The emblem is composed of three curved lines that suggest the wings and body of a bird, symbolizing health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2013
JOHN D. TAMERIUS SENIOR VICE PRESIDENT, CLINICAL AND REGULATORY AFFAIRS QUIDEL CORPORATION 10165MCKELLAR COURT SAN DIEGO CA 92121
Re: K130398
Trade/Device Name: Sofia® RSV FIA Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: I Product Code: GQG Dated: June 28, 2013 Received: July 1. 2013
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. 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.
6
Page 2-Dr. Tamerius
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/Resourcesfor You/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/MedicalDevices/Safety/ReportalProblem/default.hum 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sally A. Hojvat -S
Sally Hojvat. Ph.D., M. Sc Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K130398
Device Name: Sofia® RSV FIA
Indications For Use:
The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients less than 19 years of age. 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 result is presumptive, and it is recommended these results be confirmed by virus culture or an FDA-cleared RSV molecular assay.
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)
Tamara V. Fēldblīgum -S 2013.08.13 11-2:24:23 -04'00'
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________