The Alere BinaxNOW® Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Alere BinaxNOW® Influenza A & B Card 2 must be read by the Alere™ Reader.

Performance characteristics for influenza A were established during the 2015-2016 influenza season 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.

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 Alere BinaxNOW® Influenza A & B Card 2 is an immunochromatographic membrane assay that detects influenza type A and B nucleoprotein antigens in respiratory specific antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip is mounted inside a cardboard, book-shaped hinged test card.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into Elution Solution. Sample is added to the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of Sample Lines. Alere BinaxNOW® Influenza A & B Card 2 test results must be read by the Alere™ Reader.

The Alere™ Reader is an easy to use bench top instrument that can be used near patient and in laboratory settings which will interpret, capture and transmit test results. The Alere™ Reader is a camera based instrument that detects the presence and identity of the Alere BinaxNOW® Influenza A& B Card 2 assay, analyzes the intensity of the test and control lines and displays the results (positive or invalid) on a display screen. The screen is intended as a means of user interface informing the user how to operate the Reader and to display test results, including any errors. Data can be retrieved and downloaded by the operator at any time after testing and uploaded to the hospital LIS/LIM system, if desired. Operator ID and Subject ID can be entered manually or via the provided barcode scanner. An external printer can be attached via USB to the Alere™ Reader to print test results.

AI/ML Overview

This is a 510(k) premarket notification for a software modification to the Alere™ Reader, which is used with the Alere BinaxNOW® Influenza A & B Card 2 assay. The purpose of the submission is to introduce a "Walk Away" mode to the reader's software, alongside other minor enhancements. The underlying immunochromatographic assay (Alere BinaxNOW® Influenza A & B Card 2) itself remains unchanged.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on a software modification to the Alere™ Reader. It explicitly states: "There have been no changes to the Alere BinaxNOW® Influenza A & B Card 2 test." Therefore, the clinical performance (e.g., sensitivity, specificity) of the assay itself is not being re-evaluated or re-established by this specific submission, but rather the performance of the reader in interpreting those results.

The document discusses analytical performance for the reader with the new software. The acceptance criteria for the analytical studies were generally for the Alere™ Reader with the new software to maintain non-inferiority to the predicate reader (K162642) and to perform reliably in its new "Walk Away" mode.

Acceptance Criteria for Reader Performance (Implicit in comparative studies):

Accuracy of Interpretation: The modified Reader should accurately interpret positive and negative results from the Alere BinaxNOW® Influenza A & B Card 2, consistently with the predicate device and visual interpretation.
Timing Accuracy: The "Walk Away" mode should accurately time the 15-minute incubation period.
Reliability: The Reader should operate reliably without significant errors or invalid results.

Reported Device Performance (from the document, primarily from the Analytical Performance section, not provided here but typically found in a full 510(k) submission):

Analytical Sensitivity and Specificity: The document implies that the analytical performance (e.g., limit of detection, cross-reactivity) of the test card itself is unchanged, as the card hasn't been modified. The analytical performance of the reader with the new software would be demonstrated by its ability to accurately read a range of low-positive and negative samples consistently.
Reader Equivalence: The submission aims to demonstrate that the modified Reader is substantially equivalent to the predicate (K162642) through comparative studies, which would show consistent reading of results between the two reader versions.
"Walk Away" Mode Functionality: The new mode would have been tested to ensure it correctly times and reads the assay at the appropriate interval.

Since comprehensive performance data tables are not in the provided text, a complete table of acceptance criteria and reported numbers cannot be created. The document focuses on declaring substantial equivalence based on the software change.

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

The provided document describes the software modification and its comparison to the predicate device. It states, "The purpose of this Special 510k submission is to bring to market a modification of the software contained on the Alere™ Reader. There have been no changes to the Alere BinaxNOW® Influenza A & B Card 2 test."

This implies that the clinical performance data (sensitivity and specificity for influenza detection) would primarily come from the predicate device's original studies (K162642) or general knowledge of the Alere BinaxNOW® Influenza A & B Card 2 assay's performance.

For the software modification itself, the typical studies would involve:

Analytical Studies: Testing the new reader's ability to interpret positive and negative control cards, as well as cards with varying antigen concentrations (potentially low-positive). These studies would use a specific number of test cards, but this number is not provided in the excerpt.
Comparison Studies (Reader vs. Predicate Reader): Testing both the modified reader and the predicate reader on the same set of test cards (potentially clinical samples or spiked samples) to ensure concordance. The sample size for such a comparison is not provided in the excerpt.

Data Provenance: Not explicitly stated for specific test sets related to the software modification. Clinical performance characteristics mentioned (for the assay) were established during the 2015-2016 influenza season.

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

For this type of submission (software modification to an existing reader for an IVD), the "ground truth" for the reader's performance would likely be:

Reference Method for Assay Results: For clinical performance, a "gold standard" laboratory method like cell culture or an FDA-cleared molecular assay (as mentioned in the Indications for Use) would be used to establish the true presence/absence of influenza in patient samples. This is for the assay's performance, not the reader's.
Visual Interpretation: For evaluating the reader's accuracy, human visual interpretation by trained personnel (who are considered "experts" in reading the specific lateral flow assay) would often serve as a comparison, or the positive/negative status of contrived samples would be known from spiking.

The document does not provide specific details on the number or qualifications of experts used to establish ground truth for the reader's performance in this particular 510(k) submission.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for test sets related to the software modification. For analytical studies comparing reader performance, adjudication might involve a third reader or a consensus if discrepancies arise between the reader and a human interpreter. However, this is not explicitly stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This device is an automated reader for a rapid influenza antigen test. It is not an AI-assisted diagnostic tool designed to improve human reader performance. The Alere™ Reader replaces human visual interpretation of the test card. Its purpose is to provide an objective, automated reading of the results from the immunochromatographic assay. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The Alere™ Reader is a standalone device in the sense that it automatically interprets the test card and reports a result (positive, negative, or invalid) without human interpretation of the test lines. The human interaction is limited to inserting the card and reading the displayed result. The "algorithm" is the reader's software that analyzes the intensity of the test and control lines. The studies supporting this submission would evaluate the performance of this algorithm (software) in correctly reading the test cards.

7. The Type of Ground Truth Used

For the assay's (Alere BinaxNOW® Influenza A & B Card 2) clinical performance (established during the predicate device's evaluation), the indications for use state: "Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay." This indicates that cell culture or an FDA-cleared molecular assay would be considered the ground truth for determining actual influenza infection.

For the reader's performance (the focus of this specific 510(k) for software modification), the ground truth would likely be established by:

Known concentrations of analyte: For analytical sensitivity.
Visual interpretation by trained personnel: For concordance studies of the reader against human interpretation of the test card.
Results from the predicate reader: For demonstrating substantial equivalence of the modified reader.

8. The Sample Size for the Training Set

The document does not provide information about a specific training set. The Alere™ Reader's software likely uses image processing and pattern recognition algorithms that would have been developed and refined using a dataset of test cards (a "training set") to learn to identify and interpret the presence and intensity of test and control lines. However, the size or nature of such a training set is not disclosed in this regulatory summary.

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

As with the training set size, the method for establishing ground truth for any training data used to develop the reader's software is not provided in this document. Typically, for such image-based interpretation systems, ground truth for training data would be established by:

Manual annotation: Experienced individuals would visually inspect and label images of test cards (e.g., "positive for A," "negative," "invalid").
Spiked samples with known concentrations: Cards created with precise amounts of antigen to represent known positive or negative results.
Comparison to a gold standard: For cards from clinical samples, their true status would be confirmed by a reference method (e.g., PCR, cell culture).

Summary

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December 13, 2017

Alere Scarborough, Inc. Benjamin Crystal Manager, Regulatory Affairs - Infectious Disease 10 Southgate Road Scarborough, Maine 04074

Re: K173502

Trade/Device Name: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Regulation Number: 21 CFR 866.3328 Regulation Name: Influenza virus antigen detection test systems Regulatory Class: Class II Product Code: PSZ Dated: November 10, 2017 Received: November 13, 2017

Dear Benjamin Crystal:

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

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803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

Steven R. Gitterman -S for

Uwe Scherf, 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) K173502

Device Name

Alere BinaxNOW Influenza A & B Card 2 and Alere Reader

Indications for Use (Describe)

The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Alere BinaxNOW Influenza A & B Card 2 must be read by the Alere Reader.

Performance characteristics for influenza A were established during the 2015-2016 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.

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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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K173502

SUBMITTER

Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Establishment Registration Number: 1221359

PRIMARY CONTACT PERSON

Benjamin Crystal (207) 730-5820 (Office) (207) 730-5767 (FAX) Benjamin.crystal@alere.com (email)

SECONDARY CONTACT PERSON

Angela Drysdale (207) 415 - 1393 (Mobile) (207) 730 – 5737 (Office) Angela.drysdale@alere.com (email)

DATE PREPARED

11/7/2017

TRADE NAME

Alere BinaxNOW® Influenza A & B Card 2 Alere ™ Reader

COMMON NAME

BinaxNOW® Influenza A & B Card 2, BinaxNOW® Card 2, Alere Influenza A & B 2, BinaxNOW® Flu Card 2/Reader, Lateral Flow Reader, Card Test Analyzer

CLASSIFICATION NAME

Influenza virus antigen detection test system 21 CFR 866.3328

CLASSIFICATION

Class II

PRODUCT CODE

PSZ, Devices detecting influenza A, B and C virus antigens

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PANEL

Microbiology (83)

PREDICATE DEVICE

Alere BinaxNOW® Influenza A & B Card 2 and Alere™ Reader, K162642

DEVICE DESCRIPTION

INTENDED USE

The Alere BinaxNOW® Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Neqative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Alere BinaxNOW® Influenza A & B Card 2 must be read by the Alere™ Reader.

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Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

COMPARISON TO THE PREDICATE

The purpose of this Special 510k submission is to bring to market a modification of the software contained on the Alere™ Reader. There have been no changes to the Alere BinaxNOW® Influenza A & B Card 2 test. To facilitate flexibility in the testing workflow of the software has been modified to allow the user to use the Alere™ Reader according to the current procedure, utilizing "Read Now" mode, where the Alere BinaxNOW® Influenza A & B Card 2 assay is performed and timed on the bench and inserted in the Alere™ Reader at the read time, as well as, "Walk Away" mode, where the Alere BinaxNOW® Influenza A & B Card 2 assay is performed and inserted in the Alere™ Reader upon closing. The Alere™ Reader will time the test for the user, read the test and report the read time. In addition to the new "Walk Away" mode, the modified software incorporates additional updates and enhancements to the Alere™ Reader.

In the table below, the Alere BinaxNOW® Influenza A & B Card 2 with the modified Alere™ Reader is compared to the legally marketed predicate device, the 510(k) cleared Alere BinaxNOW® Influenza A & B Card 2 and Alere™ Reader.

Parameter	Alere BinaxNOW® Influenza A & B Card 2and Alere™ Reader(with software modification)	Alere BinaxNOW® Influenza A & BCard 2 and Alere™ Reader(K162642)
FDA Product Code	PSZ	Same
Assay Target	Influenza A, Influenza B	Same
Intended Use	The Alere BinaxNOW® Influenza A & B Card 2 isan in vitro immunochromatographic assay for thequalitative detection of influenza A and Bnucleoprotein antigens in nasopharyngeal (NP)swab and nasal swab specimens. It is intended toaid in the rapid differential diagnosis of influenzaA and B viral infections. Negative test results arepresumptive and should be confirmed by cellculture or an FDA-cleared influenza A and Bmolecular assay. Negative test results do notpreclude influenza viral infection and should notbe used as the sole basis for treatment or otherpatient management decisions. AlereBinaxNOW® Influenza A & B Card 2 must be readby the Alere™ Reader.Performance characteristics for influenza A wereestablished during the 2015-2016 influenzaseason when influenza A/H3N2 and A/H1N1pandemic were the predominant influenza Aviruses in circulation. When other influenza Aviruses are emerging, performance characteristics	Same

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Parameter	Alere BinaxNOW® Influenza A & B Card 2and Alere™ Reader(with software modification)	Alere BinaxNOW® Influenza A & BCard 2 and Alere™ Reader(K162642)
	may vary.If infection with a novel influenza A virus issuspected based on current clinical andepidemiological screening criteria recommendedby public health authorities, specimens should becollected with appropriate infection controlprecautions for novel virulent influenza virusesand sent to state or local health department fortesting. Viral culture should not be attempted inthese cases unless a BSL 3+ facility is available toreceive and culture specimens.
IntendedEnvironment forUse	Professional use, in a medical laboratory or pointof care (CW170003)	Same
Instrumentation	Alere™ Reader	Same
Assay Information
Sample Type	Nasal and Nasopharyngeal Swab	Same
Detection Format	The camera-based Alere™ Reader detects thepresence and identity of the Alere BinaxNOW®Influenza A & B Card 2 assay, analyzes theintensity of the sample and control line andreports the results (positive, negative, or invalid)on a display screen.	Same
Internal Control	Yes	Same
Assay Result	Qualitative	Same
Time to Result	15 minutes	Same

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.