(90 days)
Not Found
No
The device description mentions "method-specific algorithms" for processing results, which is a standard computational approach and does not indicate the use of AI or ML. There are no mentions of AI, ML, deep learning, neural networks, or training/test data sets, which are typically associated with AI/ML technologies in medical devices.
No
This device is a diagnostic tool used to detect influenza A and B antigens, aiding in the rapid differential diagnosis of acute influenza viral infections. It does not provide treatment or directly impact a patient's health through therapeutic means.
Yes
The device is intended "as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections," which clearly indicates a diagnostic purpose.
No
The device description clearly outlines a physical immunoassay cassette and the Sofia instrument, which is a hardware component used to scan the test strip and process results. While software is involved in processing the results, the device is not solely software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the device is intended for "use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections." This is a diagnostic purpose.
- Specimen Type: The device analyzes "nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash in fresh or transport media specimens from symptomatic patients." These are biological specimens taken from the human body.
- Method: The device employs "immunofluorescence to detect influenza B viral nucleoprotein antigens." This is a laboratory-based method for analyzing biological samples.
- Device Description: The description details a "lateral-flow immunoassay" that analyzes a "patient specimen."
All of these characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Sofia Influenza A +B FIA employs immunofluorescence to detect influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash in fresh or transport media specimens from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. Negative results do not prectude influenza virus infections and should not be used as for treatment or other management decisions. The test is intended for professional and laboratory use.
Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California 7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine". Performance characteristics may vary against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Product codes (comma separated list FDA assigned to the subject device)
GNX
Device Description
The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with Sofia to detect influenza virus nucleoproteins. This test allows for the differential detection of influenza A and influenza B antigens.
The Sofia Influenza A+B FIA is a lateral-flow immunoassay that uses monoclonal antibodies that are specific for influenza antigens and have no known cross-reactivity to normal flora or other known respiratory pathogens.
Nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens (both fresh and in VTM) are used for this test. 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 influenza viral antigen is present, they will be trapped in a specific location.
Note: Depending upon the user's choice, the cassette is either placed inside Sofia 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 to be scanned (Read Now Mode).
Sofia will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Sofia will display the test results (Positive, 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
Nasal, nasopharyngeal
Indicated Patient Age Range
Not Found
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)
Studies were undertaken to document the performance characteristics and the substantial equivalence of the test to the predicate devices. These studies included the following:
- . An analytical study to determine the Limit of Detection (LoD) using two (2) strains of Influenza A and two (2) strains of Influenza B viruses in negative clinical nasal matrix from virus transport mediums.
- . A multi-center field clinical study was performed, and the data was submitted to verify the performance of specimens in Viral Transport Media.
These studies demonstrate the substantial equivalence of the Sofia Influenza A+B FIA to the existing product already marketed. They further demonstrate the suitability of the product for use with Viral Transport Media.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3328 Influenza virus antigen detection test system.
(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that resembles an abstract representation of a human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
Quidel Corporation Edward Brehm, Ph.D. Regulatory Affairs Manager 12544 High Bluff Drive, Suite 200 San Diego, CA 92130
Re: K153012
Trade/Device Name: Sofia® Influenza A+B FIA Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: I Product Code: GNX Dated: October 13, 2015 Received: October 14, 2015
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,
Tamara V. Feldblyum -S for
Uwe Scherf Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153012
Device Name Sofia® Influenza A+B FIA
Indications for Use (Describe)
The Sofia Influenza A +B FIA employs immunofluorescence to detect influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash in fresh or transport media specimens from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. Negative results do not prectude influenza virus infections and should not be used as for treatment or other management decisions. The test is intended for professional and laboratory use.
Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California 7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine". Performance characteristics may vary against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ 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 Quidel. The logo features a square with a smaller square cut out of the bottom right corner. The larger square is filled with a gradient of colors, including red, orange, yellow, green, blue, and purple. The word "QUIDEL" is written in a sans-serif font below the square.
5. 510(K) SUMMARY
5.1. Submitted By:
Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, California 92130 Telephone: 858-552-1100x1015 Fax: 858-646-8045
Submission Contact: 5.2.
Edward C. Brehm, Ph.D.
5.3. Date Prepared
October 13, 2015
5.4. Device Trade Name:
Sofia® Influenza A+B FIA
5.5. Common Name:
Influenza A+B immunological test system
5.6. Predicate Device:
Sofia Influenza A+B FIA (K112177 and K131606)
5.7. Device Classification/Name:
21 CFR 866.3330 / Influenza virus serological reagents
Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza is an acute respiratory tract disease, which is often epidemic.
The Food and Drug Administration has classified serological test systems for the detection of influenza virus as Class I.
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Image /page/4/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square shape with a smaller square cut out of the bottom right corner. The larger square is filled with a gradient of colors, ranging from yellow and green at the top left to red and blue at the bottom right. Below the square is the word "QUIDEL" in a simple, sans-serif font.
5.8. Intended Use:
The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash in fresh or transport media specimens from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by cell culture or an FDAcleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity--United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine". Performance characteristics may vary against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
5.9. Physiologic Basis of the Test:
Influenza viruses are causative agents of highly contagious, acute, viral infections of the respiratory tract.
Influenza viruses are immunologically diverse, single-stranded RNA viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with most serious epidemics. Type B viruses produce a disease that is generally milder than that caused by type A. Type C viruses have never been associated with a large epidemic of human disease. Both Type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season.
Every year in the United States, on average 5% to 20% of the population contract influenza; more than 200,000 people are hospitalized from influenza complications; and, about 36,000 people die from influenza-related causes. Some people, such as adults 65 years of age and older, young children, and people with certain health conditions, are at high risk for serious influenza complications.
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Image /page/5/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with a smaller square in the lower right corner. The larger square is filled with a gradient of colors, including red, orange, yellow, green, blue, and purple. Below the square is the word "QUIDEL" in a sans-serif font.
Device Description: 5.10.
The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with Sofia to detect influenza virus nucleoproteins. This test allows for the differential detection of influenza A and influenza B antigens.
The Sofia Influenza A+B FIA is a lateral-flow immunoassay that uses monoclonal antibodies that are specific for influenza antigens and have no known cross-reactivity to normal flora or other known respiratory pathogens.
Nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens (both fresh and in VTM) are used for this test. 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 influenza viral antigen is present, they will be trapped in a specific location.
Note: Depending upon the user's choice, the cassette is either placed inside Sofia 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 to be scanned (Read Now Mode).
Sofia will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Sofia will display the test results (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.
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Image /page/6/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square divided into two parts. The larger part is a gradient of colors, including red, orange, yellow, green, and blue. The smaller part is a blue square. Below the square is the word "QUIDEL" in a sans-serif font.
5.11. Device Comparison:
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Features | Sofia Influenza A+B FIA | Sofia Influenza A+B FIA |
| Intended Use | The Sofia Influenza A+B FIA | |
| employs immunofluorescence to | ||
| detect influenza A and influenza B | ||
| viral nucleoprotein antigens in nasal | ||
| swab, nasopharyngeal swab, and | ||
| nasopharyngeal aspirate/wash in | ||
| fresh or transport media specimens | ||
| from symptomatic patients. The test | ||
| is intended for use as an aid in the | ||
| rapid differential diagnosis of acute | ||
| influenza A and influenza B viral | ||
| infections. The test is not intended | ||
| to detect influenza C antigens. A | ||
| negative test is presumptive and it is | ||
| recommended these results be | ||
| confirmed by cell culture or an | ||
| FDA-cleared influenza A and B | ||
| molecular assay. Negative results do | ||
| not preclude influenza virus | ||
| infections and should not be used as | ||
| the sole basis for treatment or other | ||
| management decisions. The test is | ||
| intended for professional and | ||
| laboratory use. | The Sofia Influenza A+B FIA | |
| employs immunofluorescence to | ||
| detect influenza A and influenza B | ||
| viral nucleoprotein antigens in nasal | ||
| swab, nasopharyngeal swab, and | ||
| nasopharyngeal aspirate/wash | ||
| specimens taken directly from | ||
| symptomatic patients. The test is | ||
| intended for use as an aid in the | ||
| rapid differential diagnosis of acute | ||
| influenza A and influenza B viral | ||
| infections. The test is not intended | ||
| to detect influenza C antigens. A | ||
| negative test is presumptive and it is | ||
| recommended these results be | ||
| confirmed by cell culture or an | ||
| FDA-cleared influenza A and B | ||
| molecular assay. Negative results do | ||
| not preclude influenza virus | ||
| infections and should not be used as | ||
| the sole basis for treatment or other | ||
| management decisions. The test is | ||
| intended for professional and | ||
| laboratory use. | ||
| Specimen Types | Nasal swab, Nasopharyngeal swab, | |
| and nasopharyngeal aspirate/wash | ||
| specimens both direct and in VTM | Direct Nasal swab, Nasopharyngeal | |
| swab, and nasopharyngeal | ||
| aspirate/wash specimens | ||
| Clinical | ||
| Performance Data | Fresh and with Viral Transport | |
| Media | Fresh only | |
| Read Results | Same | Read results on instrument screen or |
| print with optional printer | ||
| Instrument | Same | Sofia Analyzer |
| Calibrator | Same | Yes; a Calibration Cassette and QC |
| Card are provided | ||
| Read Result Time | Same | 15 Minutes |
| Item | Proposed Device | Predicate Device |
| Features | Sofia Influenza A+B FIA | Sofia Influenza A+B FIA |
| External Controls | Same | Test kit contains Positive and |
| Negative Control swabs |
Confidential
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Image /page/7/Picture/0 description: The image shows the logo for Quidel. The logo consists of a square with rounded corners that is divided into four quadrants. The top two quadrants are filled with a colorful, mosaic-like pattern, while the bottom two quadrants are white. Below the square is the word "QUIDEL" in a simple, sans-serif font.
Summary of Performance Data 5.12.
Studies were undertaken to document the performance characteristics and the substantial equivalence of the test to the predicate devices. These studies included the following:
- . An analytical study to determine the Limit of Detection (LoD) using two (2) strains of Influenza A and two (2) strains of Influenza B viruses in negative clinical nasal matrix from virus transport mediums.
- . A multi-center field clinical study was performed, and the data was submitted to verify the performance of specimens in Viral Transport Media.
5.13. Conclusion
These studies demonstrate the substantial equivalence of the Sofia Influenza A+B FIA to the existing product already marketed. They further demonstrate the suitability of the product for use with Viral Transport Media. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.