(32 days)
GNX
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 is no mention of AI, ML, or related concepts like training or test sets for algorithmic development.
No
The device is a diagnostic tool designed to detect influenza antigens, not to deliver therapy.
Yes
The device detects influenza A and B viral nucleoprotein antigens to aid in the rapid differential diagnosis of acute influenza A and B viral infections, which is a diagnostic purpose.
No
The device description explicitly mentions the "Sofia Analyzer," which is a hardware component used to scan the test strip and measure the fluorescent signal. The software runs on this analyzer to process the results.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for use "as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections." This clearly indicates that the device is used to examine specimens taken from the human body to provide information for diagnostic purposes.
- Specimen Type: The device uses "nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients." These are human specimens.
- Technology: The device employs "immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens." This is a laboratory technique used to analyze biological samples.
- User: The test is intended for "professional and laboratory use," which aligns with the typical use environment for IVDs.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
These tests are used to aid in the diagnosis of influenza and provide epidemiological information on influenza (21 CFR 866.3330). The Food and Drug Administration has classified serological test systems for the detection of influenza virus as Class I.
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. 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 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.
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.
Product codes
GNX
Device Description
The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with the Sofia Analyzer to detect influenza virus nucleoproteins.
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 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 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, Neqative, 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
Immunofluorescence
Anatomical Site
Nasopharyngeal, Nasal
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)
An analytical study was performed to assess the ability of the Sofia Influenza A+B FIA to detect the Influenza A virus H7N9 (A/Anhui/1/2013) and establish the Limit of Detection. The results of this study show that Sofia Influenza A+B FIA detects H7N9 with a minimum detectable level of 3.95 x 10 degree Egg Infective Dose (EID)30/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sofia Influenza A+B FIA
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3330 Influenza virus serological reagents.
(a)
Identification. 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. Influenza is an acute respiratory tract disease, which is often epidemic.(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 the limitations in § 866.9.
0
510(k) SUMMARY
JUL 0 5 2013
l
| 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. |
| Date Prepared: | May 30, 2013 |
| Device Trade Name: | Sofia® Influenza A+B FIA |
| Common Name: | Influenza A+B immunological test |
| Predicate Devices: | Sofia Influenza A+B FIA |
| Device Classification/Name: | 21 CFR 866.3330 / Influenza virus serological
reagents |
| Intended Use: | These tests are used to aid in the diagnosis of
influenza and provide epidemiological information on
influenza (21 CFR 866.3330). The Food and Drug
Administration has classified serological test systems
for the detection of influenza virus as Class I.
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. 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 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.
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 |
1
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.
lf 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.
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, singlestranded 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 older people, voung children, and people with certain health conditions, are at high risk for serious influenza complications.
2
Device Description:
The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with the Sofia Analyzer to detect influenza virus nucleoproteins.
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 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 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, Neqative, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.
3
Device Comparison:
| ltem | Proposed Device | Proposed 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 | ||
| specimens taken directly 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 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. | ||
| 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 | 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. 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 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. | ||
| 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 aqainst | ||
| 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 | cases unless a BSL 3+ facility is | |
| available to receive and culture | ||
| specimens. | specimens. | |
| Item | Proposed Device | Proposed Device |
| Features | Sofia Influenza A+B FIA | Sofia Influenza A+B FIA |
| Read Results | Read results on instrument | |
| screen or print with optional | ||
| printer | Read results on instrument | |
| screen or print with optional | ||
| printer | ||
| Instrument | Sofia Analyzer | Sofia Analyzer |
| Calibrator | Yes - Calibration Cassette and QC | |
| Card provided | Yes - Calibration Cassette and QC | |
| Card provided | ||
| Specimen | ||
| Types | nasal swab, nasopharyngeal swab, | |
| and nasopharyngeal aspirate/wash | nasal swab, nasopharyngeal swab, | |
| and nasopharyngeal aspirate/wash | ||
| Read Result | ||
| Time | 15 Minutes | 15 Minutes |
| External | ||
| Controls | Test kit contains Positive and | |
| Negative Control swabs | Test kit contains Positive and | |
| Negative Control swabs |
4
Summary of Performance Data:
An analytical study was performed to assess the ability of the Sofia Influenza A+B FIA to detect the Influenza A virus H7N9 (A/Anhui/1/2013) and establish the Limit of Detection.
Conclusion:
The results of this study show that Sofia Influenza A+B FIA detects H7N9 with a minimum detectable level of 3.95 x 10° Egg Infective Dose (EID)30/mL. The Sofia Influenza A+B FIA is substantially equivalent with the current Sofia Influenza A+B FIA.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JOHN D TAMERIUS SENIOR VICE PRESIDENT OF CLINICAL AND REGULATORY AFFAIRS QUIDEL CORPORATION 10165 MCKELLAR COURT SAN DIEGO CA 92121
July 5,2013
Re: K131606
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: May 30, 2013 Received: June 05, 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 rou may, aroney interest 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/ResourcesforYou/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.fdag.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sally A. Hojvat -S
Sally A. 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
Intended Use
510(k) Number (if known): K131606
Device Name: Sofia® Influenza A+B FIA
Intended Use: The Sofia Influenza A+B FJA employs immunofluorescence to detect influenza B viral nucleoprotein antigens in nasal swab, and nasopharyngeal aspiratelwash specimens taken directly 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 negalive 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 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 oredominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entiled "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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)
Tamara V. Feldblyum -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K131606