The QuickVue Influenza A+B Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type 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 viral 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 patient management decisions. The test is intended for professional and laboratory use.

Performance characteristics for influenza A were established during the 2017/2018 influenza A/ H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A 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. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Device Description

The QuickVue Influenza A+B Test involves the extraction of influenza A and B viral antigens. The patient specimen is placed in the Extraction Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After extraction, the Test Strip is placed in the Extraction Reagent Tube where nucleoproteins in the specimen will react with the reagents in the Test Strip.

If the extracted specimen contains influenza A or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. The Test Line for influenza A or B will develop at separate specified locations on the same Test Strip. If influenza A or B antigens are not present, or are present at very low levels, only the blue procedural Control Line will appear.

AI/ML Overview

The provided text describes the QuickVue Influenza A+B Test, an influenza virus antigen detection test system, and a study conducted to demonstrate its performance and substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, formatted as requested:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated in a quantitative table within the provided text. However, the document indicates that the study was performed "to confirm the device meets the performance characteristics detailed in 21 CFR 866.3328 for Class II influenza virus antigen detection test systems" and that the device "meets the performance requirements according to FDA's reclassification of rapid Influenza assays."

While specific numerical targets are not given in this document, the implication is that the accuracy (sensitivity and specificity) of the QuickVue Influenza A+B Test must be sufficient to meet the regulatory requirements for a Class II influenza virus antigen detection test system.

Table 1: Implied Acceptance Criteria and Study Conclusion

Acceptance Criteria (Implied)	Reported Device Performance
Meets performance characteristics detailed in 21 CFR 866.3328 for Class II influenza virus antigen detection test systems.	"The results of this study demonstrate that the QuickVue Influenza A+B Test meets the performance requirements according to FDA's reclassification of rapid Influenza assays."
Substantially equivalent to predicate device (Sofia Influenza A+B FIA).	"The QuickVue Influenza A+B test is substantially equivalent with the predicate device, Sofia Influenza A+B FIA." (This implies comparable performance characteristics, though specific numbers for the QuickVue device are not reported in this summary). The document also mentions that performance characteristics for influenza A were established during the 2017/2018 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. This indirectly suggests the device performed adequately against these prevalent strains to meet regulatory requirements.

Acceptance Criteria (Implied)

Reported Device Performance

Meets performance characteristics detailed in 21 CFR 866.3328 for Class II influenza virus antigen detection test systems.

"The results of this study demonstrate that the QuickVue Influenza A+B Test meets the performance requirements according to FDA's reclassification of rapid Influenza assays."

Substantially equivalent to predicate device (Sofia Influenza A+B FIA).

"The QuickVue Influenza A+B test is substantially equivalent with the predicate device, Sofia Influenza A+B FIA." (This implies comparable performance characteristics, though specific numbers for the QuickVue device are not reported in this summary). The document also mentions that performance characteristics for influenza A were established during the 2017/2018 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. This indirectly suggests the device performed adequately against these prevalent strains to meet regulatory requirements.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The document mentions "Additional Clinical Studies were performed."
- Data Provenance: Not explicitly stated. The performance characteristics for influenza A were established during the 2017/2018 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. This suggests prospective collection during a relevant influenza season, but the specific country/region is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text.
- Ground truth confirmation is mentioned as "viral culture or an FDA-cleared influenza A and B molecular assay." This implies laboratory methods rather than expert consensus on initial interpretation for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text. The use of "viral culture or an FDA-cleared influenza A and B molecular assay" for confirmation suggests a definitive laboratory reference method, which might negate the need for a subjective adjudication process by multiple readers for the ground truth.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable to the QuickVue Influenza A+B Test. This device is described as a rapid, qualitative antigen detection test read "visually" (for the proposed device) or by a "Reader" (for the predicate device, Sofia Influenza A+B FIA, which is an immunofluorescence assay implying an instrument reader). The technology described does not involve AI or human-in-the-loop performance improvement with AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the QuickVue Influenza A+B Test is a manual, visual assay. While the Sofia predicate device uses an instrument "Reader," this is a read-out of the immunofluorescence signal, not an AI algorithm performing diagnostic interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for negative test results is recommended to be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. This indicates a high-standard laboratory reference method is used for establishing ground truth.
The sample size for the training set:
- Not specified. The document refers to "Additional Clinical Studies." It does not directly mention a 'training set' in the context of machine learning, as this is a traditional in-vitro diagnostic device.
How the ground truth for the training set was established:
- Not applicable in the context of a machine learning training set for this type of device. The performance characteristics were established during clinical studies, with negative results confirmed by viral culture or an FDA-cleared molecular assay.

Summary

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Quidel Corporation Jennifer Rial Director, Regulatory Affairs 10165 McKellar Court San Diego, California 92121

February 13, 2018

Re: K180288

Trade/Device Name: OuickVue Influenza A+B Regulation Number: 21 CFR 866.3328 Regulation Name: Influenza virus antigen detection test systems Regulatory Class: Class II Product Code: PSZ Dated: January 31, 2018 Received: February 2, 2018

Dear Jennifer Rial:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Uwe Scherf -S

Uwe Scherf, MSc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180288

Device Name QuickVue Influenza A+B Test

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

✑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image features the logo for Quidel. The logo consists of a square with rounded corners, divided into two sections. The larger section is a gradient of colors, including yellow, green, red, and purple. The smaller section is blue. Below the square is the word "QUIDEL" in a sans-serif font.

7. SPECIAL 510(K) SUMMARY

Submitted By:	Quidel Corporation10165 McKellar CourtSan Diego, California 92121
	Telephone: 858-552-7910
	Fax: 858-646-8045
Submission Contact:	Jennifer S. Rial, Director, Regulatory Affairs
Date Prepared:	January 25, 2018
Device Trade Name:	QuickVue® Influenza A+B Test
Common Name:	Influenza A+B immunological test
Predicate Devices:	Sofia Influenza A+B FIA, K162438
Device Classification/Name:	21 CFR 866.3328 / Class II / Influenza virus antigendetection system
	An influenza virus antigen detection test system is a deviceintended for the qualitative detection of influenza viralantigens directly from clinical specimens in patients withsigns and symptoms of respiratory infection. The test aidsin the diagnosis of influenza infection and providesepidemiological information on influenza. Due to thepropensity of the virus to mutate, new strains emerge overtime which may potentially affect the performance of thesedevices. Because influenza is highly contagious and maylead to an acute respiratory tract infection causing severeillness and even death, the accuracy of these devices hasserious public health implications.

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Image /page/4/Picture/0 description: The image features the logo for Quidel. The logo consists of a square shape with rounded corners, divided into four quadrants. The top-left quadrant displays a gradient of colors, including yellow, orange, red, and pink. The bottom-right quadrant is colored in shades of blue and purple. Below the square is the word "QUIDEL" in a simple, sans-serif font.

Intended Use:

The QuickVue Influenza A+B Test allows for the rapid. qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients. 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. A negative test is presumptive, and it is recommended these results be confirmed by viral 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 patient management decisions. The test is intended for professional and laboratory use.

Performance characteristics for influenza A were established during the 2017/2018 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

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Image /page/5/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, filled with a gradient of colors including green, yellow, orange, red, and blue. A smaller blue square is positioned in the lower right corner of the larger square. Below the square is the word "QUIDEL" in a sans-serif font.

Physiologic Basis of the Test:	Influenza viruses are causative agents of highlycontagious, acute, viral infections of the respiratory tract.Influenza viruses are immunologically diverse, single-stranded RNA viruses. There are three types of influenzaviruses: A, B, and C. Type A viruses are the most prevalentand are associated with most serious epidemics. Type Bviruses produce a disease that is generally milder than thatcaused by type A. Type C viruses have never beenassociated with a large epidemic of human disease. BothType A and B viruses can circulate simultaneously, butusually one type is dominant during a given season.
	Every year in the United States, on average 5% to 20% ofthe population contract influenza; more than 200,000people are hospitalized from influenza complications; andabout 36,000 people die from influenza-related causes.Some people, such as older people, young children, andpeople with certain health conditions, are at high risk forserious influenza complications.
Device Description:	The QuickVue Influenza A+B Test involves the extractionof influenza A and B viral antigens. The patient specimenis placed in the Extraction Reagent Tube, during whichtime the virus particles in the specimen are disrupted,exposing internal viral nucleoproteins. After extraction, theTest Strip is placed in the Extraction Reagent Tube wherenucleoproteins in the specimen will react with the reagentsin the Test Strip.
	If the extracted specimen contains influenza A or Bantigens, a pink-to-red Test Line along with a blueprocedural Control Line will appear on the Test Stripindicating a positive result. The Test Line for influenza Aor B will develop at separate specified locations on thesame Test Strip. If influenza A or B antigens are notpresent, or are present at very low levels, only the blueprocedural Control Line will appear.

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Image /page/6/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, divided into two sections. The top section is a gradient of colors, including yellow, orange, red, and green. The bottom section is a gradient of blue and purple. The word "QUIDEL" is written in black, sans-serif font below the square shape.

Device Comparison

Item	Proposed Device	Previously Cleared Device	Predicate Device
Features	QuickVue Influenza A+B Test	QuickVue Influenza A+B Test	Sofia Influenza A+B FIA
Intended Use	The QuickVue Influenza A+B Test allows forthe rapid, qualitative detection of influenzatype A and type B antigens directly in nasalswab and nasopharyngeal swab specimensfrom symptomatic patients. The test isintended for use as an aid in the rapiddifferential diagnosis of acute influenza typeA and type B viral infections. The test is notintended to detect influenza C antigens. Anegative test is presumptive, and it isrecommended these results be confirmed byviral culture or an FDA-cleared influenza Aand B molecular assay. Negative results do notpreclude influenza virus infections and shouldnot be used as the sole basis for treatment orother patient management decisions. The testis intended for professional and laboratory use.	The QuickVue Influenza A+B Test allows forthe rapid, qualitative detection of influenza typeA and type B antigens directly from nasal swab,nasopharyngeal swab, nasal aspirate, and nasalwash specimens. The test is intended for use asan aid in the rapid differential diagnosis of acuteinfluenza type A and type B viral infections. Thetest is not intended to detect influenza Cantigens. Negative results should be confirmedby cell culture; they do not preclude influenzavirus infection and should not be used as the solebasis for treatment or other managementdecisions. The test is intended for professionaland laboratory use.	The Sofia Influenza A+B FIA employsimmunofluorescence to detect influenza Aand influenza B viral nucleoprotein antigensin direct nasal swab, nasopharyngeal swab,and nasopharyngeal aspirate/washspecimens and nasopharyngeal swab andnasopharyngeal aspirate/wash specimens intransport media from symptomatic patients.This qualitative test is intended for use as anaid in the rapid differential diagnosis ofacute influenza A and influenza B viralinfections. The test is not intended to detectinfluenza C antigens. A negative test ispresumptive and it is recommended theseresults be confirmed by viral culture or anFDA-cleared influenza A and B molecularassay. Negative results do not precludeinfluenza virus infections and should not beused as the sole basis for treatment or otherpatient management decisions. This test isintended for professional and laboratory use.
Item	Proposed Device	Previously Cleared Device	Predicate Device
Features	QuickVue Influenza A+B Test	QuickVue Influenza A+B Test	Sofia Influenza A+B FIA
Intended Use (cont.)	Performance characteristics for influenza Awere established during the 2017/2018influenza seasons when influenza A/H3N2and A/H1N1 pandemic were the predominantinfluenza A viruses in circulation. When otherinfluenza A viruses areemerging,performance characteristics may vary.If infection with a novel influenza A virus issuspected based on current clinical andepidemiological screening criteriarecommended by public health authorities,specimens should be collected withappropriate infection control precautions fornovel virulent Influenza viruses and sent tostate or local health department for testing.Viral culture should not be attempted in thesecases unless a BSL 3+ facility is available toreceive and culture specimens.	--	The Sofia Influenza A+B FIA may be usedwith Sofia or Sofia 2.Performance characteristics for influenza Aand B were established during Februarythrough March 2011 when influenza virusesA/California/7/2009 (2009 H1N1),A/Perth/16/2009 (H3N2), andB/Brisbane/60/2008 (Victoria-Like) werethe predominant influenza viruses incirculation according to the Morbidity andMortality Weekly Report from the CDCentitled "Update: Influenza Activity---United States, 2010-2011 Season, andComposition of the 2011-2012 InfluenzaVaccine." Performance characteristics mayvary against other emerging influenzaviruses.If infection with a novel influenza virus issuspected based on current clinical andepidemiological screening criteriarecommended by public health authorities,samples should be collected with appropriateinfection control precautions for novelvirulent influenza viruses and sent to state orlocal health department for testing. Viralculture should not be attempted in thesecases unless a BSL 3+ facility is available toreceive and culture samples.
Item	Proposed Device	Previously Cleared Device	Predicate Device
Features	QuickVue Influenza A+B Test	QuickVue Influenza A+B Test	Sofia Influenza A+B FIA
Read Results	Visual	Visual	Reader
Specimen Types	Nasal swab, nasopharyngeal swab	Nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash	Direct nasal swab, nasopharyngeal swab and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media
Read Result Time	10 minutes	10 minutes	15 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

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Image /page/7/Picture/0 description: The image shows the logo for Quidel. The logo features a square with rounded corners that is divided into four quadrants. The top left quadrant is filled with a gradient of colors, including yellow, green, blue, and red. The bottom right quadrant is filled with a dark blue color. The bottom of the image shows the word "QUIDEL" in a sans-serif font.

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Image /page/8/Picture/0 description: The image shows the logo for Quidel. The logo features a square with rounded corners, divided into four quadrants. The top left quadrant is a gradient of colors, including yellow, green, and red. The bottom right quadrant is blue. Below the square is the word "QUIDEL" in a sans-serif font.

7.1. Summary of Performance Data

Additional Clinical Studies were performed using the QuickVue Influenza A+B Test to confirm the device meets the performance characteristics detailed in 21 CFR 866.3328 for Class II influenza virus antigen detection test systems.

7.2. Conclusion

The results of this study demonstrate that the QuickVue Influenza A+B Test meets the performance requirements according to FDA's reclassification of rapid Influenza assays. The QuickVue Influenza A+B test is substantially equivalent with the predicate device, Sofia Influenza A+B FIA.

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.