(88 days)
GNX, KHO
Not Found
No
The device description mentions "method-specific algorithms" for processing results, but there is no mention of AI or ML, training data, or complex image processing that would typically indicate the use of such technologies. The performance studies described are standard for immunoassay validation.
No
The device is a diagnostic test ("qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections") and does not provide therapy or treatment.
Yes
The intended use explicitly states, "This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections." This indicates its purpose is to help identify a disease, which is the definition of a diagnostic device.
No
The device description clearly outlines a hardware component, the Sofia Analyzer, which is essential for processing the test strip and measuring the fluorescent signal. 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 that the device is used 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 involves testing specimens taken from the human body to provide information about a disease state (influenza).
- Specimen Type: The device uses "nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens," which are biological specimens obtained from the human body.
- Purpose: The purpose is to "aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections." This is a diagnostic purpose, providing information to help healthcare professionals diagnose a condition.
- Technology: The device employs "immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens," which is a common technique used in in vitro diagnostic tests.
- Device Description: The description details a "lateral-flow immunoassay" that uses antibodies to detect antigens in a specimen, a typical format for IVD tests.
All of these characteristics 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 determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for 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 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 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, KHO
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 F1A 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, 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
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)
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to the predicate devices. 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 nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens.
- 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 influenza concentrations.
- Analytical studies included Limit of Detection, analytical reactivity, cross reactivity, interfering substances, operating temperature, lab precision/repeatability, viral transport media, inter-analyzer reproducibility, calibration cycle, and various flex studies.
Conclusion: These studies demonstrated the substantial equivalence of the Sofia Analyzer and Sofia Influenza A+B FIA to existing products already marketed. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity and specificity were calculated using nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens. (Specific values not provided in this summary)
Predicate Device(s)
3M™ Rapid Detection Flu A+B Reader and Test, QuickVue® Influenza A+B Test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K112.177
OCT 2 4 2011
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. |
| Date Prepared: | July 25, 2011 |
| Device Trade Name: | Sofia™ Analyzer and Influenza A+B FIA |
| Common Name: | Influenza A+B immunological test system |
| Predicate Devices: | 3M™ Rapid Detection Flu A+B Reader and Test
QuickVue® Influenza A+B Test |
| Device Classification/Name: | 21 CFR 866.3330 / Influenza virus serological
reagents |
| | 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. |
| 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 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 |
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.
Influenza viruses are causative agents of highly Physiologic Basis of the Test: 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 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 vear 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, young 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 F1A 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, 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 Devices | |
|---|---|---|---|
| Features | Sofia™ Analyzer and | ||
| Influenza A+B FIA | 3M™ Rapid Detection Flu | ||
| A+B Reader and Test | QuickVue® Influenza A+B | ||
| Test | |||
| 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 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 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. | The 3M™ Rapid Detection Flu | ||
| A+B Test is a qualitative | |||
| immunochromatographic assay | |||
| used to identify the presence of | |||
| Influenza A and Influenza B | |||
| nucleoprotein antigens in nasal | |||
| wash, nasal aspirate, | |||
| nasopharyngeal aspirate, and | |||
| nasopharyngeal swab | |||
| specimens from symptomatic | |||
| patients. It is an in vitro | |||
| diagnostic assay that aids in | |||
| the rapid differential diagnosis | |||
| of influenza viral infections in | |||
| symptomatic patients. A | |||
| negative test is presumptive | |||
| and it is recommended these | |||
| results be confirmed by cell | |||
| culture. Negative results do | |||
| not preclude influenza virus | |||
| infection and should not be | |||
| used as the sole basis for | |||
| treatment of other | |||
| management decision. | The QuickVue® Influenza A+B | ||
| test allows for the rapid, | |||
| qualitative detection of | |||
| influenza type A and type B | |||
| antigens directly from nasal | |||
| swab, nasopharyngeal swab, | |||
| nasal aspirate, and nasal wash | |||
| specimens. The test is | |||
| intended for use as an aid in | |||
| the rapid differential diagnosis | |||
| of acute influenza type A and | |||
| type B viral infections. The test | |||
| is not intended to detect | |||
| influenza C antigens. Negative | |||
| results should be confirmed by | |||
| cell culture; they do not | |||
| preclude influenza virus | |||
| infection and should not be | |||
| used as the sole basis for | |||
| treatment or other | |||
| management decisions. The | |||
| test is intended for professional | |||
| and laboratory use. | |||
| Item | Proposed Device | Predicate Devices | |
| Features | SofiaTM Analyzer and | ||
| Influenza A+B FIA | 3MTM Rapid Detection Flu | ||
| A+B Reader and Test | QuickVue® Influenza A+B | ||
| Test | |||
| Read Results | Read results on instrument | ||
| screen or print with optional | |||
| printer | Read results on instrument | ||
| screen or print with optional | |||
| printer | Visual read for presence or | ||
| absence of control and test | |||
| lines | |||
| Instrument | Sofia Analyzer | 3M Rapid Detection Reader | None |
| Calibrator | Yes - Calibration Cassette and QC | ||
| Card provided | Yes - Lot Card contains | ||
| calibration and expiration | |||
| information | Not Applicable | ||
| Specimen | |||
| Types | nasal swab, nasopharyngeal swab, | ||
| and nasopharyngeal aspirate/wash | nasopharyngeal swab, nasal | ||
| wash, nasal aspirate, and | |||
| nasopharyngeal aspirate | nasal swab, nasopharyngeal | ||
| swab, nasal aspirate, and | |||
| nasal wash | |||
| Read Result | |||
| Time | 15 Minutes | 15 Minutes | 10 Minutes |
| External | |||
| Controls | Test kit contains Positive and | ||
| Negative Control swabs | Test kit contains Positive and | ||
| Negative Control swabs | Test kit contains Positive and | ||
| Negative Control swabs |
4
Summary of Performance Data:
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to the predicate devices. 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 nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens.
-
- 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 influenza concentrations.
-
- Analytical studies included Limit of Detection, analytical reactivity, cross reactivity, interfering substances, operating temperature, lab precision/repeatability, viral transport media, inter-analyzer reproducibility, calibration cycle, and various flex studies.
Conclusion:
These studies demonstrated the substantial equivalence of the Sofia Analyzer and Sofia Influenza A+B FIA to existing products already marketed. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Quidel Corporation c/o John D. Tamerius, Ph.D. Sr. Vice President, Clinical and Regulatory Affairs 10165 McKellar Court San Diego, CA 92121
OCT 2 4 2011
Re: K112177
Trade/Device Name: Sofia™ Analyzer and Influenza A+B FIA Regulation Number: 21 CFR$ 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: Class I Product Code: GNX, KHO Dated: September 21, 2011 Received: September 22, 2011
Dear Dr. Tamerius:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
6
Page 2 - John D. Tamerius, Ph.D
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely vours.
Sally, Axtorp
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Device Name:
Sofia™ Analyzer and Influenza A+B FIA
Indications for Use:
The Sofia Influenza A+B FlA 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 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 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.
x_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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 Diagnostic Device Evaluation and Safety (OIVD)
Laura Feldshuh
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of
510(k) K 112177