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.

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.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Sofia™ Analyzer and Influenza A+B FIA

The Sofia™ Analyzer and Influenza A+B FIA is a qualitative immunofluorescence assay intended to detect influenza A and influenza B viral nucleoprotein antigens in various respiratory specimens. The acceptance criteria and supporting study details are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. Instead, it demonstrates "substantial equivalence" to predicate devices through various performance studies. The clinical study results against a "gold standard" (presumably virus culture or FDA-cleared molecular assay) are as follows:

Performance Metric	Influenza A (Nasal Swab, Nasopharyngeal Swab, Nasopharyngeal Aspirate/Wash)	Influenza B (Nasal Swab, Nasopharyngeal Swab, Nasopharyngeal Aspirate/Wash)
Sensitivity	Established in multi-center field clinical study	Established in multi-center field clinical study
Specificity	Established in multi-center field clinical study	Established in multi-center field clinical study
Reproducibility	Demonstrated intra- and inter-operator and lab reproducibility	Demonstrated intra- and inter-operator and lab reproducibility

Note: The document states that a multi-center field clinical study was undertaken to "document the performance characteristics" including sensitivity and specificity, but the specific numerical values for these metrics are not provided in the summary. The "acceptance criteria" appear to be met by demonstrating performance comparable to the predicate devices and overall suitability for its intended use, as indicated by the FDA's clearance of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The exact number of specimens collected for the "multi-center field clinical study" is not explicitly stated in the provided text.
Data Provenance: The studies were conducted during "February through March 2011" when specific influenza strains (A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-like)) were predominant according to a CDC report. This implies the data was collected prospectively from United States (or potentially other regions following the CDC report) symptomatic patients during an influenza season.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set. It refers to the ground truth as "virus culture or an FDA-cleared influenza A and B molecular assay." These methods are typically standardized laboratory procedures and do not inherently require human expert interpretation in the same way, for example, a radiological image would.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The ground truth, being "virus culture or an FDA-cleared influenza A and B molecular assay," typically yields definitive results that do not necessitate adjudication among multiple human interpreters.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in the provided text. This study is an in-vitro diagnostic device and aims for direct detection of viral antigens, rather than an AI-assisted diagnostic aid for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone Performance Study

Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was performed. The "multi-center field clinical study" evaluated the Sofia™ Analyzer and Influenza A+B FIA directly against "virus culture or an FDA-cleared influenza A and B molecular assay," which represents the standalone performance of the device in detecting the target analytes. The device itself (Sofia Analyzer) reads the test strip and displays results (Positive, Negative, or Invalid) using "method-specific algorithms."

7. Type of Ground Truth Used

The type of ground truth used was expert laboratory methods, specifically "virus culture or an FDA-cleared influenza A and B molecular assay." This aligns with the gold standard for influenza diagnosis.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This type of diagnostic device, relying on immunofluorescence and specific antibodies, does not typically undergo a machine learning training phase in the same way an AI algorithm for image analysis would. The development likely involved extensive analytical studies and optimization, but not explicit "training" on a distinct dataset as understood in AI/ML contexts.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit mention of a "training set" in the context of an AI/ML algorithm, the method for establishing its ground truth is not applicable or described in the provided text. The foundational data for developing and optimizing the assay would have come from established laboratory techniques for identifying influenza viruses.

Summary

{0}------------------------------------------------

K112.177

OCT 2 4 2011

510(k) SUMMARY

Submitted By:	Quidel Corporation10165 McKellar CourtSan Diego, California 92121Telephone: 858-552-7908Fax: 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 TestQuickVue® Influenza A+B Test
Device Classification/Name:	21 CFR 866.3330 / Influenza virus serologicalreagents
	These tests are used to aid in the diagnosis ofinfluenza and provide epidemiological information oninfluenza (21 CFR 866.3330). The Food and DrugAdministration has classified serological test systemsfor the detection of influenza virus as Class I.
Intended Use:	The Sofia Influenza A+B FIA employsimmunofluorescence to detect influenza A andinfluenza B viral nucleoprotein antigens in nasal swab,nasopharyngeal swab, and nasopharyngealaspirate/wash specimens taken directly fromsymptomatic patients. This qualitative test is intendedfor use as an aid in the rapid differential diagnosis ofacute influenza A and influenza B viral infections. Thetest is not intended to detect influenza C antigens. Anegative test is presumptive and it is recommendedthese results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. Negativeresults do not preclude influenza virus infections andshould not be used as the sole basis for treatment orother management decisions. The test is intended forprofessional and laboratory use.Performance characteristics for influenza A and Bwere established during February through March2011 when influenza viruses A/California/7/2009(2009 H1N1), A/Perth/16/2009 (H3N2), andB/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.

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 andInfluenza A+B FIA	3M™ Rapid Detection FluA+B Reader and Test	QuickVue® Influenza A+BTest
Intended Use	The Sofia Influenza A+B FIAemploys immunofluorescence todetect influenza A and influenza Bviral nucleoprotein antigens in nasalswab, nasopharyngeal swab, andnasopharyngeal aspirate/washspecimens taken directly fromsymptomatic patients. Thisqualitative test is intended for use asan aid in the rapid differentialdiagnosis of acute influenza A andinfluenza B viral infections. The testis not intended to detect influenza Cantigens. A negative test ispresumptive and it is recommendedthese results be confirmed by virusculture or an FDA-cleared influenzaA and B molecular assay. Negativeresults do not preclude influenzavirus infections and should not beused as the sole basis for treatmentor other management decisions. Thetest is intended for professional andlaboratory use.Performance characteristics forinfluenza A and B were establishedduring February through March2011 when influenza virusesA/California/7/2009 (2009 H1N1),A/Perth/16/2009 (H3N2), andB/Brisbane/60/2008 (Victoria-Like)were the predominant influenzaviruses in circulation according tothe Morbidity and Mortality WeeklyReport from the CDC entitled"Update: Influenza Activity--UnitedStates, 2010-2011 Season, andComposition of the 2011-2012Influenza Vaccine". Performancecharacteristics may vary againstother emerging influenza viruses.If infection with a novel influenzavirus is suspected based on currentclinical and epidemiologicalscreening criteria recommended bypublic health authorities, specimensshould be collected with appropriateinfection control precautions fornovel virulent influenza viruses andsent to state or local healthdepartment for testing. Virus cultureshould not be attempted in thesecases unless a BSL 3+ facility isavailable to receive and culturespecimens.	The 3M™ Rapid Detection FluA+B Test is a qualitativeimmunochromatographic assayused to identify the presence ofInfluenza A and Influenza Bnucleoprotein antigens in nasalwash, nasal aspirate,nasopharyngeal aspirate, andnasopharyngeal swabspecimens from symptomaticpatients. It is an in vitrodiagnostic assay that aids inthe rapid differential diagnosisof influenza viral infections insymptomatic patients. Anegative test is presumptiveand it is recommended theseresults be confirmed by cellculture. Negative results donot preclude influenza virusinfection and should not beused as the sole basis fortreatment of othermanagement decision.	The QuickVue® Influenza A+Btest allows for the rapid,qualitative detection ofinfluenza type A and type Bantigens directly from nasalswab, nasopharyngeal swab,nasal aspirate, and nasal washspecimens. The test isintended for use as an aid inthe rapid differential diagnosisof acute influenza type A andtype B viral infections. The testis not intended to detectinfluenza C antigens. Negativeresults should be confirmed bycell culture; they do notpreclude influenza virusinfection and should not beused as the sole basis fortreatment or othermanagement decisions. Thetest is intended for professionaland laboratory use.
Item	Proposed Device	Predicate Devices
Features	SofiaTM Analyzer andInfluenza A+B FIA	3MTM Rapid Detection FluA+B Reader and Test	QuickVue® Influenza A+BTest
Read Results	Read results on instrumentscreen or print with optionalprinter	Read results on instrumentscreen or print with optionalprinter	Visual read for presence orabsence of control and testlines
Instrument	Sofia Analyzer	3M Rapid Detection Reader	None
Calibrator	Yes - Calibration Cassette and QCCard provided	Yes - Lot Card containscalibration and expirationinformation	Not Applicable
SpecimenTypes	nasal swab, nasopharyngeal swab,and nasopharyngeal aspirate/wash	nasopharyngeal swab, nasalwash, nasal aspirate, andnasopharyngeal aspirate	nasal swab, nasopharyngealswab, nasal aspirate, andnasal wash
Read ResultTime	15 Minutes	15 Minutes	10 Minutes
ExternalControls	Test kit contains Positive andNegative Control swabs	Test kit contains Positive andNegative Control swabs	Test kit contains Positive andNegative 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:

1. 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.
1. 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.
1. 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.

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

Regulation Number and Section

§ 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.