(128 days)
No
The device description mentions "method-specific algorithms" for processing results, but there is no mention of AI, ML, or any learning-based approach. The performance studies focus on traditional analytical and clinical validation metrics, not AI/ML model performance.
No
The device is used for diagnosis of RSV infections, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as an aid in the rapid diagnosis of acute RSV infections."
No
The device description clearly outlines a hardware component, the Sofia or Sofia 2 instrument, which is a microprocessor-controlled device that scans the test strip and measures fluorescent signals. The software runs on this hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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 specimens taken from the body, which is a key characteristic of an IVD.
- Device Description: The description details how the test works by analyzing a "patient specimen" and detecting "RSV viral antigens." This process of analyzing a biological sample outside of the body to gain information about a patient's health status is the definition of an in vitro diagnostic.
- Anatomical Site: The specimens are taken from "Nasopharyngeal swab and nasopharyngeal aspirate/wash specimens," which are biological samples.
- Prescription Use: The indication of "Prescription Use (Part 21 CFR 801 Subpart D)" is common for IVDs used in a clinical setting.
- Predicate Device: The predicate device listed is "K130398; Sofia RSV FIA performed on Sofia," which is also an IVD. This further supports the classification of this device as an IVD.
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. 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 viral culture or an FDA-cleared RSV molecular assay.
The Sofia RSV FIA may be used with the Sofia or Sofia 2.
Product codes
GQG, KHO
Device Description
The Sofia RSV FIA test employs immunofluorescence technology that is used with Sofia 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 Sofia or Sofia 2 for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (Read Now Mode).
Sofia or Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Test results will be displayed (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.
Sofia 2 is a microprocessor-controlled device about the size of a desk top telephone and weighs less than 3 pounds. Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal swab and nasopharyngeal aspirate/wash specimens
Indicated Patient Age Range
pediatric patients
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
Numerous studies were undertaken to document the performance characteristics of Sofia 2 and the Sofia RSV assay, as well as to compare the performance between Sofia and Sofia 2. The studies included the following:
-
a. Limit of Detection (LoD)
This study confirmed that the LoD generated for the Sofia RSV FIA on Sofia 2 is equivalent to the LoD generated on Sofia. -
b. Precision
This study confirmed that Sofia and Sofia 2 generated equivalent qualitative results when used by multiple operators to test negative and positive concentrations that are close to the positivity threshold, on multiple device lots, operated over multiple days, and two calibration cycles. -
c. Assay development time
This study confirmed that when running Sofia 2 in Read Now mode, a development time of eight (8) to thirty (30) minutes is acceptable. -
d. Early Read
This study confirmed that when running Sofia 2 in Walk Away mode, positive samples (depending on the viral load) can be interpreted as positive as early as 3 minutes. -
e. Method Comparison
This study demonstrated that Sofia and Sofia 2 have comparable performance when using a panel of clinical samples. -
f. Reproducibility
This study demonstrated intra- and inter-operator reproducibility and interlaboratory reproducibility with a panel of test samples at various RSV concentrations. This study also demonstrated comparable performance between Sofia and Sofia 2.
Key Metrics
Not Found
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Quidel Corporation Edward C. Brehm, PhD Regulatory Affairs Manager 12544 High Bluff Drive, Suite 200 San Diego, CA 92130
February 22, 2017
Re: K162911
Trade/Device Name: Sofia® RSV FIA Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: I Product Code: GOG Dated: October 14, 2016 Received: October 24, 2016
Dear Dr. Brehm:
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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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" (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 Industry and Consumer Education 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 yours,
Uwe Scherf -S
Uwe Scherf, 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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Indications for Use
510(k) Number (if known) K162911
Device Name Sofia® RSV FIA
Indications for Use (Describe)
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. 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 viral culture or an FDA-cleared RSV molecular assay.
The Sofia RSV FIA may be used with the Sofia or Sofia 2.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with rounded corners, divided into two sections. The top section is a gradient of colors, including red, orange, yellow, green, blue, and purple. The bottom section is a smaller square that is blue and purple. Below the square is the word "QUIDEL" in a sans-serif font.
5. 510(K) SUMMARY
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5.1. Submitter
Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, California 92130 Telephone: 858-552-1100, X-21015 Fax: 858-646-8045
5.2. Submission Contact
Edward C. Brehm, Ph.D.
5.3. Date Prepared
February 21, 2017
5.4. Proprietary and Established Names
Sofia® RSV FIA performed on Sofia 2
5.5. Common Name
Same as above
Regulatory Information 5.6.
| Product Code | Classification | Regulatory Section | Panel |
|---|---|---|---|
| GQG | I | 21 CFR 866.3480 | Microbiology |
| KHO | I | 21 CFR 862.2560 | Clinical Chemistry per regulation; Microbiology because it is used with the Sofia RSV FIA |
5.7. Predicate Device
Sofia RSV FIA performed on Sofia
5.8. Device Description
The Sofia RSV FIA test employs immunofluorescence technology that is used with Sofia 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
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Image /page/5/Picture/0 description: The image features the logo of Quidel. The logo consists of a square with rounded corners, filled with a gradient of colors resembling a rainbow. Inside the square is a smaller, white square with rounded corners, creating a frame-like effect. The word "QUIDEL" is written in a simple, sans-serif font below the square logo.
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 Sofia or Sofia 2 for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (Read Now Mode).
Sofia or Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Test results will be displayed (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.
Sofia 2 is a microprocessor-controlled device about the size of a desk top telephone and weighs less than 3 pounds. Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results.
5.9. 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. 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 viral culture or an FDA-cleared RSV molecular assay.
The Sofia RSV FIA may be used with Sofia or Sofia 2.
5.10. Substantial Equivalence Information:
- Predicate Device Name: Sofia RSV FIA performed on Sofia 1.
-
- Predicate 510(k) Numbers: K130398
-
- Comparison with Predicate:
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| Similarities and Differences | ||
|---|---|---|
| Item | Sofia RSV FIA on Sofia | |
| K130398 | Sofia RSV FIA on Sofia 2 | |
| K162911 | ||
| 510(k) Number | K130398 | K162911 |
| 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. 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 viral | ||
| culture or an FDA-cleared RSV | ||
| molecular assay. | 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. 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 viral | ||
| culture or an FDA-cleared RSV | ||
| molecular assay. | ||
| The Sofia RSV FIA may be used with | ||
| Sofia or Sofia 2. | ||
| Calibration Check | Calibration Check required every 30 | |
| days or less, as set by the supervisor. A | ||
| special Calibration Cassette is provided | ||
| with the Installation Pack. | Same and uses the same Calibration | |
| Cassette | ||
| Development | ||
| Modes | Two basic assay development modes: | |
| • Walk-Away: User can walk away | ||
| during the assay cassette | ||
| development period | ||
| • Read Now: User manually times the | ||
| assay cassette development period | ||
| outside of Sofia, then places cassette | ||
| in Sofia to image and provide test | ||
| result. | Same | |
| Development Time | 15 minutes for Sofia RSV FIA | Potential for early read in Walk-Away |
| Mode. Sofia 2 will image cassette at 3, | ||
| 5, 8, 10, and 15 minutes until a positive | ||
| result is received. | ||
| System | ||
| Components | ||
| User interface | 3.5 inch diagonal color LCD display and | |
| numeric keypad with function specific | ||
| buttons | 4 inch color LCD touchscreen display | |
| Similarities and Differences | ||
| Item | Sofia RSV FIA on Sofia | Sofia RSV FIA on Sofia 2 |
| 510(k) Number | K130398 | K162911 |
| User Types | Has 2 distinct security levels; user and supervisor plus a Quidel only service level. | Same |
| Barcode | ||
| scanner(sample) | External hand held barcode scanner | Integrated barcode scanner but same functionality |
| Barcode | ||
| scanner(cassette) | Integrated barcode scanner | Same using custom integrated 0.3 MP camera |
| Assay / instrument interface | Drawer (electro-mechanical) | Same (manual) |
| Determine test type | Instrument scans barcode on cassette | Same |
| Power Supply | 100 – 240 VAC, self-switching, or with 4 AA batteries | 100 – 240 VAC, self-switching, or with rechargeable lithium polymer battery |
| Printer | Integrated printer | External printer connected via USB port (DYMO LabelWriter 450 Printer supported), optional network printer. |
| Dimensions | 24 cm deep x 16 cm wide x 10 cm high | 19.7 cm deep x 11.4 cm wide x 12.7 cm high |
| Weight | 3 lbs | ~2.5 lbs |
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Image /page/7/Picture/0 description: The image features the logo for Quidel. The logo consists of a square divided into four quadrants, each filled with a different color. The top left quadrant is a gradient of warm colors, including red, orange, and yellow. The top right quadrant is a gradient of green and blue. The bottom left quadrant is a gradient of purple and pink. The bottom right quadrant is a gradient of blue and purple. Below the square is the word "QUIDEL" in a sans-serif font.
5.11. Performance Data
Numerous studies were undertaken to document the performance characteristics of Sofia 2 and the Sofia RSV assay, as well as to compare the performance between Sofia and Sofia 2. The studies included the following:
-
a. Limit of Detection (LoD)
This study confirmed that the LoD generated for the Sofia RSV FIA on Sofia 2 is equivalent to the LoD generated on Sofia. -
b. Precision
This study confirmed that Sofia and Sofia 2 generated equivalent qualitative results when used by multiple operators to test negative and positive concentrations that are close to the positivity threshold, on multiple device lots, operated over multiple days, and two calibration cycles. -
c. Assay development time
This study confirmed that when running Sofia 2 in Read Now mode, a development time of eight (8) to thirty (30) minutes is acceptable. -
d. Early Read
This study confirmed that when running Sofia 2 in Walk Away mode, positive samples (depending on the viral load) can be interpreted as positive as early as 3 minutes. -
Method Comparison e.
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Image /page/8/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square divided into four quadrants, each filled with a different color gradient. The top-left quadrant transitions from yellow to green, the top-right from orange to red, the bottom-left from light blue to purple, and the bottom-right from dark blue to purple. Below the square is the word "QUIDEL" in a simple, sans-serif font.
This study demonstrated that Sofia and Sofia 2 have comparable performance when using a panel of clinical samples.
- f. Reproducibility
This study demonstrated intra- and inter-operator reproducibility and interlaboratory reproducibility with a panel of test samples at various RSV concentrations. This study also demonstrated comparable performance between Sofia and Sofia 2.
5.12. Conclusion
These studies demonstrated equivalent performance of the Sofia RSV FIA on the Sofia and Sofia 2 analyzer.